prima

SURGICAL TECHNIQUE PRIMA STEM

PRIMA Stem

4 Indications, Contraindications, Warnings and Risk Factors 8 Surgical Steps 10 Introduction

12 Surgical Technique 12 Humerus Preparation 22 PRIMA Anatomic 26 PRIMA Reverse 29 Components Removal 31

Conversion from Anatomic to Reverse

Annex 1 - Measurement chart

34 Instrument set 42 Product codes

Limacorporate spa is a manufacturer of prosthetic implants and as such does not perform medical procedures. This documentation concerning surgical techniques, which provides surgeons with general guidelines for implanting the PRIMA Humeral System, which was developed with the advice of a team of surgical experts. All decisions as to the type of surgery and most suitable technique are obviously the responsibility of the health care professional. Surgeons must make their own decisions as to the adequacy of each planned implant technique based on their training, experience and the clinical condition of the patient.

PRIMA Stem Surgical technique

Indications, Contraindications, Warnings and Risk Factors

Contraindications Absolute contraindications include: • local or systemic general infection; • septicaemia; • persistent acute or chronic local or systemic osteomyelitis; • confirmed neurologic lesion compromising shoulder joint function; • in case of reverse prosthesis, deltoid muscle insufficiency; • poor bone stock compromising stability

Warnings

Consult instruction for use provided in the product package

In selecting patients for surgery, the following factors can be critical to the eventual success of the procedure: • Partial Shoulder replacement : in cases of a deficient and unreconstructable rotator cuff, a CTA-head is indicated; • Total Shoulder replacement : the rotator cuff must be functional, intact or reconstructable. In cases of a deficient and unreconstructable rotator cuff, a hemiprosthesis with a CTA head or a Reverse Total Shoulder Arthroplasty is indicated; • Reverse Shoulder replacement : the bone stock of the glenoid and humerus must be able to support the implant. In cases of significant bone loss or in which adequate

of the implant (severe fracture of the proximal humerus, meta- epiphyseal pseudoarthrosis, osteoporosis,

osteomalacia, extended bone loss after previous prosthetic or non-prosthetic surgery); • tumor; • serious muscular, neurological, or vascular diseases compromising stability of the implant. Relative contraindications include: • proximal humerus fracture sequelae with inadequate bone stock; • vascular or nerve diseases affecting the concerned limb; • metabolic disorders which may impair fixation and stability of the implant; • any concomitant disease that might affect the implanted prosthesis; • metal hypersensitivity to implant materials (CoCrMo); • patient with significant renal impairment.

fixation on the glenoid side cannot be obtained, a hemiarthroplasty with a CTA- head should be performed.

Note. For SMR Shoulder System components refer to the proper Instructions for Use leaflet.

Risk Factors The following factors may result in poor results with this prosthesis: • overweight*; • strenuous physical activities (active sports, heavy physical work); • incorrect implant positioning; • muscle deficiencies; • multiple joint disabilities; • refusal to modify postoperative physical activities; • patient history of infections or falls; • systemic diseases and metabolic disorders; • local or disseminated neoplastic diseases; • drug therapies that adversely affect bone quality, healing, or resistance to infection; • drug use or alcoholism; • immunocompromised patients (HIV, tumour, infections);

• severe deformity leading to impaired anchorage or improper positioning of implants; • use or combination with products, prosthesis or instruments of another manufacturer.

*According to the definition of World Health Organization (WHO), Body Mass Index (BMI) greater than or equal to 25 Kg/m².

PRIMA Stem Surgical technique

Indications The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patients. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Stem is intended for use in cementless applications. The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to: • non-inflammatory degenerative joint disease (i.e., osteoarthritis); • inflammatory degenerative glenohumeral joint disease such as rheumatoid arthritis; • avascular necrosis of the humeral head; • cuff tear arthropathy (CTA Heads only). The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e., in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).

Revision surgery with retention of the PRIMA Stem is intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses. The PRIMA Reverse implant is indicated for patients suffering from pain and disability due to: • rotator cuff tear arthropathy; • osteoarthritis with rotator cuff tear; • rheumatoid arthritis with rotator cuff tear; • massive irreparable rotator cuff tear. The PRIMA Humeral System consists of the following single use components: • Anatomic configuration: - stem, - adaptor for humeral heads, • Reverse configuration: - stem, - reverse insert.

System

Components

Material

A R ü ü

PRIMA Stem

Ti6Al4V 3D printed

Adaptor for Humeral Heads

Ti6Al4V

Reverse Insert

CoCrMo

Material Standards Ti6Al4V (ISO 5832-3 - ASTM F1472), Ti6Al4V 3D printed (ISO 5832-3) CoCrMo (ASTM F1537 and ISO 5832-12) A = Anatomic, R = Reverse

The PRIMA Humeral System is intended to be used with all glenoid implants belonging to the SMR Shoulder System. Instructions for use of SMR Shoulder System should be consulted for warnings that apply to these systems. The SMR Shoulder System components which are compatible with PRIMA Humeral System components in anatomical and in reverse configuration are:

System

Components

SMR Humeral Heads (Standard, CTA)

ü ü

SMR TT Metal Back (Baseplate and Peg)

SMR Axioma Metal Back Liner

ü ü

SMR Axioma TT Glenoid (Baseplate and Peg)

ü ü

SMR Metal Back Glenoid

ü ü

SMR TT Hybrid Glenoid

SMR Cemented Glenoid

SMR Cemented Glenoid 3-Pegs

SMR Metal Back Liner

SMR Connectors with screw

SMR Glenospheres

SMR TT Augmented 360 (Baseplate and Peg)

SMR TT Hybrid Glenoid Reverse Baseplate + Screw

SMR Bone Screw

A= Anatomic / R=Reverse

Table 2 SMR Shoulder System components compatible with PRIMA Humeral System

The following table identifies the allowed ( ü ) / not allowed ( x ) combinations between the SMR Lateralized Connectors and the SMR Glenospheres.

HP Glenospheres

Connectors

Diameter

Ecc.

LAT+4 LAT+2

ü ü

Ø40mm

Ø44mm

Ø44mm Corrective

Note. SMR Humeral Heads diameter 38 mm are not allowed to be coupled to PRIMA Humeral System. SMR Humeral Heads Dia 40mm H13, Dia 42mm H13 both neutral and eccentrical versions are not allowed to be coupled to PRIMA Humeral System. Note. The CTA head must be used only in case of good stability of PRIMA Stem. If the CTA Head has to be used, an Eccentric Adaptor must be used (the coupling with the Concentric Adaptor is not allowed) and that the eccentricity is in the cranial direction only.

PRIMA Stem Surgical technique

Surgical Steps

3 mm

0.5 mm

RESECT

SIZE AND PLACE PIN

REAM

COMPACT

TRIAL STEM

ANATOMIC

TRIAL HEAD

DEFINITIVE HEAD

DEFINITIVE STEM HEAD ADAPTOR

REVERSE

DEFINITIVE STEM DEFINITIVE INSERT

TRIAL INSERT

PRIMA Stem Surgical technique

Introduction

Access There are two recommended surgical

approaches to the shoulder joint. As in every surgical procedure, the access depends on diagnosis, planned surgical procedure and the experience of the surgeon. Shoulder range of motion may be evaluated with the patient under anesthesia to confirm the preoperative assessment and the extent of capsular release needed to restore the ROM postoperatively.

Preoperative planning LimaCorporate products should be implanted only by surgeons familiar with the joint replacement procedures described in the specific surgical techniques. Pre-operative planning, through radiographic templates in different formats, provides essential information regarding the type and size of components to be used and the correct combination of required devices based on the anatomy and specific conditions of each patient. Inadequate pre-operative planning can lead to improper selection of the implants and/or incorrect implant positioning. In selecting patients for surgery, the following factors can be critical to the eventual success of the procedure: the bone stock of the glenoid and humerus must be able to support the implant. In cases with significant bone loss and in which adequate fixation on the glenoid side cannot be obtained, a hemiarthroplasty with a CTA-head should be performed. Positioning Shoulder arthroplasty is normally performed in a “beach- chair” position; the surgeon needs complete access to the shoulder joint. The arm is free or stabilized by arm-holders. The shoulder must be positioned off the edge of the table to afford unobstructed arm extension. The patient’s head must be supported and stabilized in the neutral position. Nerve injury due to brachial plexus traction during positioning and surgery must be avoided. The surgeon must have a complete anterior view of the shoulder and positioning should allow unobstructed movement of the shoulder joint.

Delto-pectoral approach

Anterior vertical incision starts 1 cm later to the coracoid bone, slanting towards the axillary’ pouch. If there is a metaphyseal fracture, slant the incision laterally towards the deltoid insertion at the humerus. The cephalic vein is retracted laterally with the deltoid muscle. The clavipectoral fascia is incised along the lateral edge of the conjoined tendon up to the coracoacromial ligament. A retractor can easily be placed over the superolateral aspect of the humeral head to retract the deltoid. The conjoined tendon is retracted medially. The musculocutaneous nerve penetrates the lateral coracobrachialis muscle 3 to 8 cm distally of the tip of the coracoid process. The position of the axillary nerve should be identified along the anterior surface of the subscapularis muscle, below the conjoined tendon.

The axillary nerve crosses the inferolateral border of the subscapularis 3 to 5 mm medially of its musculotendinous junction and has an intimate anatomic relation with the inferior capsule of the shoulder joint. The anterior humeral circumflex artery and veins are visualized, ligated and divided. The subscapularis tendon is released, divided 1 cm medially to its attachment or released with a bone chip of the lesser tuberosity. Separation of the subscapularis from the capsule and incision of the capsule is performed to the inferior border of the glenoid rim, protecting the axillary nerve with a blunt retractor. Release the subscapularis and perform a 360° capsular release. Antero-lateral (deltoid splitting) approach Begin the incision at the anterolateral tip of the acromion and carry it distally over the deltoid muscle about 5 cm. Define the tendinous interval on 4 to 5 cm long between the anterior and middle thirds of the deltoid; splitting the muscle here provides an avascular approach to underlying structures. Incise the thin wall of the subdeltoid bursa and explore the rotator cuff as desired by rotating and abducting the arm to bring different parts of it into view in the floor of the wound.

Closure After the definitive prosthesis has been implanted, repair of the subscapularis is recommended for reverse shoulder arthroplasty and required for anatomic shoulder arthroplasty. In case of anatomic reconstruction evaluate after reattachment of the subscapularis if closure of the rotator interval is needed for further stability or not. Closure of the deltopectoral fascia, subcutaneous adaptation and skin closure is then performed.

PRIMA Stem Surgical technique

Humerus Preparation

Dislocation of the humeral head Detach the subscapularis tendon at its insertion on the lesser tuberosity and medialize the tendon, dividing it from the underneath capsule. Perform an anterior-oblique capsulotomy, paying attention to avoid injury of the axillary nerve. A retractor, placed between the capsule and the tendon, can be used for protecting the nerve. With careful external rotation and extension (the humerus may be osteoporotic and osteophytes may block the rotation process), the humeral head is dislocated anteriorly. All humeral osteophytes are carefully removed from the humeral head so that the anatomic neck can be identified.

Foreward To complete the joint replacement hereby described, a power tool featuring a pin drive, Zimmer-Hudson connection and cutting saw blade is required.

Preoperative Planning

Pre-operative planning is highly recommended with the use of templates showing a 5% enlarged image of the profiles. Normally standard AP and Axial view of the shoulder joint are used; in some cases, a preoperative CT-Scan is recommended to perform a more accurate planning. Select the stem size and resection level of the humeral head, which will serve as a reference for the final implant height. The PRIMA prosthesis can be implanted with one of the usual approaches: • delto-pectoral • antero-lateral (deltoid splitting) The surgical technique described hereafter refers to the delto-pectoral approach.

Humeral head resection

The humeral head resection technique is performed with the PRIMA instrumentation. The humeral head resection is performed with an anatomical angle (135°) for both PRIMA Anatomic and PRIMA Reverse implants. Open the proximal end of the humerus with the awl connected to the T-handle with Zimmer connection (Figure 1). Insert the awl into the humerus until the stopper flange comes in contact with the surface of the humeral head. Connect the Ø 6 mm humeral intramedullary rod to the T-handle with AO connection and attach the cutting jig connector, finally insert the assembly into the humerus. Prepare the anatomic resection jig by properly connecting it to the guide for resection jigs (Figure 2). Connect the alignment rod to the assembly on the LEFT or the RIGHT hole of the delto-pectoral (DP) side to obtain the chosen retroversion angle (0°, 20° and 30° positions are available). Finally connect the assembly to the Ø 6 mm intramedullary rod according to the side that is being operated. For a left shoulder, the mark LEFT shall be frontally visible on the guide and vice versa the mark RIGHT for a right shoulder.

Figure 1

Guide for resection jig

Anatomic resection jig

Figure 2

PRIMA Stem Surgical technique

Retroversion Keeping the forearm flexed at 90°, rotate the resection guide until the alignment rod and the forearm are parallel (Figure 3). Then fix the selected retroversion by screwing the threaded rod (Figure 4). A resection with the chosen retroversion will then be performed in this position. If less or more retroversion is required, the rod should be externally or internally rotated, respectively.

Threaded rod

Figure 3

Figure 4

Head Resection

Once the jig is secured to the humerus with the 3mm pins, remove the IM guide by releasing the red lever and slide the guide for resection jig upwards (Figure 7). Next, remove the central Ø 6 mm intramedullary rod from the humeral canal, leaving only the cutting jig secured onto the humerus. Resect the humeral head with a blade through the guided slot of the jig (Figure 8) finally, remove the pins and the jig. If a glenoid replacement is required, please refer to the dedicated surgical technique.

Adjust the height of the resection jig level until it is aligned with the anatomic neck. Turn the red knob clockwise or counter-clockwise to move the jig proximally or distally respectively (Figure 5). A graduated scale is available to support the visualization of the height during this phase. Use the sickle to assess the resection height and once the selected height is reached secure the guide to the humerus with two Ø 3 mm pins (Figure 6).

Graduated scale

2mm

Figure 5

Figure 6

Figure 7

Figure 8

PRIMA Stem Surgical technique

If needed, the PRIMA instrumentation includes humeral covers to be applied to protect the resected humeral cut. Two options are available for this purpose: humeral plate with spikes to be applied to the humeral resections plane (Figure 9A) and monolithic humeral cover to be used with PRIMA stem trial (Figure 9B). Humeral head resection using the extramedullary cutting template Take from the instrument set the cutting template; screw the alignment rod in the chosen retroversion hole (0°, 20° and 30° positions are available). A black laser marking allows to visualize the available retroversion holes (Figure 10). For a left shoulder, the mark “L” shall be visible on the front of the template and vice versa the mark “R” for a right shoulder. Place the cutting template onto the humerus (Figure 11) and align the alignment rod with the forearm flexed at 90°, finally fix the cutting template using the Ø 3 mm pins included into the instrument set (Figure 12). A distal hole for k-wire is available to further stabilize the template, if needed (Figure 10A). The humeral head should be resected exactly at the level of the anatomical neck. Perform the head resection with an oscillating saw.

Figure 9A

Figure 9B

Figure 10A

Figure 10

Figure 11

Figure 12

Determination of the PRIMA Stem size

The instruments feature color coding to support the surgical team using the system. The PRIMA Stem is available in 5 sizes and the table below indicates the corresponding color coding.

PRIMA Stem Size Color Code #1 No Color #2 Yellow #3 Orange #4 Magenta #5 Blue

Figure 13

Figure 14

Carefully remove all humeral osteophytes from the humeral head so that the size of the PRIMA Stem can be determined. Determine the size of the PRIMA stem using the metaphyseal sizer rings. As optional, the spike bushing could be used in this surgical phase to hold the metaphyseal sizer ring onto the resected humeral plane. Pre-assemble the spike bushing to the sizer ring on the back table, till the first click is heard (Figure 13). Then slide the metaphyseal sizer ring into the Ø 6 mm intramedullary rod and place it over the resected surface (Figure 14). The PRIMA stem will be aligned with the intramedullary canal of the humerus. To determine the correct implant, the outer rim of the selected ring should be central on the resected humeral surface without overlying the cortex (Figure 15A). The metaphyseal sizer ring has protrusions that are 3mm larger than the outer rim of the ring and should be used as reference tool for the positioning. The protrusions should be contained within the trabecular portion of the resected surface (Figure 15B) and should not extend beyond the cortical rim. If not satisfied substitute the sizer ring with a different size.

On limit

Over dimensioned

Figure 15A

3mm

Figure 15B

PRIMA Stem Surgical technique

It is possible to reposition the metaphyseal sizer ring on the resected humeral surface after removing the Ø 6mm intramedullary rod (Figures 16-17). In this case, PRIMA Stem won’t be any more aligned with the intramedullary canal of the humerus. Warning: Modifying the position alters the alignment of the stem within the humeral canal, and in extreme cases diaphyseal impingement may occur. Secure the metaphyseal sizer ring to the humeral resection plane in the desired position on the resection plane by sliding the spike bushing over it until the second click is heard (Figure 18). Once the metaphyseal sizer ring is secured to the humerus, remove the Ø 6 mm intramedullary rod and insert the checking rod all the way down in the metaphyseal sizer ring. Make sure there is no cortical contact in this phase. If the checking rod is not flush on the metaphyseal sizer ring, impingement is occurring (Figure 19). Optional: mark the AP and ML reference lines along the sizer’s ring slots which can help verify the humeral trial and final implant version. Remove the checking rod and insert the metaphyseal K-Wire through the central hole in the metaphyseal sizer ring until engaged in the lateral cortex (Figure 20). Note. During this phase, to prevent soft tissue damage especially the axillary nerve, use of a Homann or other retractor as protection during drilling phase is recommended.

Figure 16

Figure 18

Figure 17

x Impingement

ü Ok

Finally remove the sizer ring and the spike bushing.

Figure 19

Figure 20

Humerus Reaming Assemble the proximal reamer of the selected size to the reamer shaft (Figure 21) and ream the humeral metaphysis, using the K-wire as a guide. The reaming is completed once the collar of the reamer sits flush with the resected surface (Figure 22). Remove the reamer, leaving the K-wire in place. Complete the preparation of the metaphyseal portion of the humerus using the proximal compactor. Assemble the proximal compactor of the selected size to the compactor & positioning handle. Impact the proximal compactor using the k-wire as a guide until the compactor’s collar sits flush on the humeral resection.

Optional. If the stem entry point is closed due to the previous reaming step, remove the k-wire and align the mediolateral reference line marked previously on the bone along the proximal compactor’s slot, insert the checking rod into the dedicated hole to refresh the stem entry point (Figure 23). Remove the compactor by tapping it out using the handle and remove the k-wire.

Note. Be aware high impact force may cause fracture of the humerus.

Figure 21

Collar

Mediolateral reference slot

Figure 22

Figure 23

PRIMA Stem Surgical technique

Insertion of the Trial Stem

For this step, the impactor must be assembled onto the PRIMA Trial Stem by using the proper size adaptor. Connect the proper size adaptor to the impactor, then assemble the trial stem to the impactor. The retroversion may be verified by screwing the alignment rod in the marked screw holes of the impactor (0°, 20° or 30°) (Figure 24). For a left shoulder, the mark “L” shall be visible on the front of the impactor and vice versa the mark “R” for a right shoulder. Impact the trial stem of the selected size into the humerus (Figure 25). The impactor has been designed to provide two impaction directions, along the axis of the stem and perpendicular to the resected surface. During insertion it is possible to verify the proper insertion by utilizing the ML marking on the trial stem that should be aligned with the medial marking, if performed during the sizing step (Figure 26). Additionally, the impactor features a mark to visualize the trial stem axis (Figure 27). Stop impacting when the adaptor comes fully in contact with the resected surface. Remove the impactor and adaptor from the trial stem. Optional during this phase, the impactor knob features a central hole for the 3.5mm hexagonal screwdriver to support the removal of the impactor from the implanted trial stem. Once the impactor and the adaptor are removed, the trial stem will be 0.5mm protruded from the resection plane to compensate the subsidence during subsequent phases (Figure 28).

Figure 24

Figure 25

Figure 26

marking

0.5mm

Figure 28

Figure 27

Humeral cover use To prevent fracture or damage to the cut humeral surface during the glenoid preparation, humeral covers are provided with the PRIMA Instrumentation. The humeral covers are available in three sizes (Small, Medium and Large) in order to fit with the humerus dimensions; please note that they are not related to the PRIMA stem sizes. Two options are available for this purpose: humeral plate with spikes to be applied to the humeral resection plane and monolithic humeral cover to be used with trial or definitive PRIMA Stem (Figure 29). The humeral cover with spikes is intended to be used after resection of the humeral head: the cover is placed on the resected surface and the fixation is obtained by means of the spikes. The monolithic humeral cover is used with trial stem in situ. If anatomic prosthesis is performed, proceed as described in “PRIMA Anatomic” on page 22. In case of reverse prosthesis, follow the surgical steps described in “PRIMA Reverse” on page 26.

Figure 29

PRIMA Stem Surgical technique

PRIMA Anatomic Trial reduction

Insert the anatomical trial adaptor into the PRIMA trial stem using the extracting pliers for reverse trial inserts (Figure 30). Apply the neutral trial adaptor taper to the trial humeral head by hand and fit the head to the adaptor on the trial stem (Figure 31). Reduce the joint and check the match with the glenoid. If it is not well aligned with the cut humeral surface, substitute the neutral trial adaptor taper with an eccentric one (2 mm, 4 mm and 6 mm are available). To remove trial adaptor tapers from the trial humeral head use the extracting pliers for trial adaptors (Figure 32). If an eccentric adaptor is used, mark the position of the eccentricity with an electric scalpel, using the arrow of the trial humeral head as a reference (Figure 33). This procedure helps to place the final head in the correct position. After trial reduction remove the trial head, trial adaptor taper using the extractor, and the trial adaptor using the extracting pliers for reverse trial inserts.

Figure 30

Finally remove the trial stem using the positioning handle.

Figure 31

Note. The trialing phase may also be performed on the definitive PRIMA Stem to assess range of motion and implant size selection, at the discretion of the surgeon, paying attention to avoid any stress to the implanted stem.

Figure 32

Figure 33

Insertion of the definitive components

Remove the PRIMA stem of the chosen size from sterile packaging and impact it into the prepared humerus using the impactor with the impactor adaptor of the chosen size (Figure 34). The retroversion may be verified by screwing the alignment rod in the marked screw holes of the impactor (0°, 20° or 30°). For a left shoulder, the mark “L” shall be visible on the front of the impactor and vice versa the mark “R” for a right shoulder. Place the PRIMA stem in the same position as the trial implant. The impactor has been designed to provide two impaction directions, along the axis of the stem and along the axis of the trial stem taper. Additionally, the impactor features a mark to visualize the PRIMA Stem axis. Stop impacting when the adaptor comes fully in contact with the resected surface. Then remove the impactor by unscrewing it from the stem. Optional during this phase, the impactor knob features a central hole for the 3.5mm hexagonal screwdriver to support the removal of the impactor from the implanted stem. Once the impactor and the adaptor are removed, the PRIMA stem will be 0.5mm protruded from the resection plane to compensate the subsidence during subsequent phases. Remove the appropriate final adaptor taper and final head from the sterile packaging. Apply the adaptor taper to the definitive stem. If an eccentric adaptor taper is used, insert it by aligning the marking with the previous marked reference (Figure 35). A safety screw is used to secure the coupling between the adaptor taper and the PRIMA stem (Figure 36).

Figure 34

Eccentric position

Figure 35

Figure 36

PRIMA Stem Surgical technique

Make sure that the contact surfaces are perfectly clean and that the head or adaptor does not contact the bone, as this could compromise the stability of the morse taper coupling. Finally reduce the shoulder joint.

Tighten the screw using the 3.5 mm allen wrench with the T-handle with Zimmer connection and the counter torque attached to the multipurpose handle to prevent load transmission (Figure 37). Apply the definitive humeral head to the adaptor taper (Figure 38) and secure the coupling by tapping with the humeral head impactor and handle assembly (Figure 39). The head should sit flush on the osteotomy plane.

T handle with Zimmer connection

Counter-torque Handle for Anatomical Adaptors

Multipurpose handle

Figure 37

Figure 38

Figure 39

CTA heads use The clinical indication for prosthetic treatment with a CTA head is by rotator cuff tear arthropathy. Note. The CTA head must be used only in case of good stability of the PRIMA stem. If the CTA Head has to be used, make sure that an Eccentric Adaptor is used (the coupling with the Concentric Adaptor is not allowed) and that the eccentricity is in the cranial direction only. To prepare the seat for the CTA Head, connect the trial humeral head dia. 40 mm (in case of dia. 42 and 46 mm definitive CTA Head) or dia. 46 mm (in case of dia. 50 and 54 mm definitive CTA Head) to the PRIMA stem by means of the dedicated connector for trial adaptor and the trial adaptor taper ecc. 2 mm, ecc. 4 mm or ecc. 6mm . Use the slots of trial head as reference to evaluate the area of the greater tuberosity where the bone has to be removed to host the CTA heads (Figure 40). Use the trial CTA heads with the trial adaptor taper ecc. 2 mm, ecc. 4 mm or 6mm to properly assess the prepared seat. Refine the seat if required until perfect seat of the trial CTA Head is achieved prior to implanting the final CTA Head.

Figure 40

PRIMA Stem Surgical technique

PRIMA Reverse Important! In the reverse configuration PRIMA Stem is intended for use only with SMR 40 mm or 44mm glenospheres. The surgeon can further choose between regular and lateralized connectors, according to the joint tensioning. Trial reduction The trial components feature color coding to support the surgical team using the system.

Figure 41

PRIMA reverse insert

Color code

Dia. 40mm

Blue

Dia. 44mm

Green

Choose the trial reverse insert according to the implanted 40 mm or 44 mm glenosphere and insert it into the trial stem by means of the extracting pliers for reverse trial inserts (Figure 41).

PRIMA reverse insert

Size

Figure 42

Insert Short

0mm

Insert Medium

+3mm

Insert Long

+6mm

Insert Medium - Offset

+3mm, 3mm offset

Insert Long - Offset +6mm, 3mm offset The trial reverse insert is available with 0° and 7° angle. If using a 7° or an OFFSET trial reverse insert, mark the position of the slit of the trial insert on the resected surface in order to reproduce it with the final implant (Figure 42). Reduce the implant to verify the shoulder tensioning and address any laxity by replacing with the next liner size. The choice of liner thickness is made by the surgeon to ensure the correct tension, prevent any laxity in the joint, restore the correct offset of the joint. To remove and replace the trial reverse insert use the extracting pliers for reverse inserts. Note. The trialing phase may also be performed on the definitive PRIMA stem to assess range of motion and implant size selection, at the discretion of the surgeon, paying attention to avoid any stress to the implanted stem.

Insertion of the definitive components

Remove the PRIMA stem of the chosen size from sterile packaging and impact it onto the humerus cavity using the impactor with the impactor adaptor of the chosen size (Figure 43). The retroversion may be verified by screwing the alignment rod in the marked screw holes of the impactor (0°, 20° or 30°) (Figure 44). For a left shoulder, the mark “L” shall be visible on the front of the impactor and vice versa the mark “R” for a right shoulder. Place the PRIMA stem in the same position as the trial implant. The impactor has been designed to provide two impaction directions, along the axis of the stem and along the axis of the trial stem taper. Additionally, the impactor features a laser mark to visualize the PRIMA Stem axis. Stop impacting when the adaptor enters in contact with the resected surface. Then remove the impactor from the stem. Optional during this phase, the impactor knob features a central hole for the 3.5mm hexagonal screwdriver to support the removal of the impactor from the implanted stem. Once the impactor and the adaptor are removed, the PRIMA stem will be 0.5mm protruded from the resection plane to compensate the subsidence during subsequent phases (Figure 45).

Figure 44

0.5mm

Figure 43

Figure 45

PRIMA Stem Surgical technique

Insertion of final PRIMA reverse insert

Open the packaging of the reverse insert that was selected during the trial reduction. Clean the PRIMA Stem and impact the insert on the stem by means of the reverse insert pusher assembled to the handle (Figure 46). If a 7° or an offset reverse insert is chosen, make sure to align the marking on the insert to the marking performed during trialing phase (Figure 47). Make sure that the contact surfaces are perfectly clean and that the insert does not contact the bone, as this could compromise the stability of the morse taper coupling. The shoulder joint may then be reduced with gentle manipulation, with or without use of the Namba slide.

Figure 46

Figure 47

Components Removal

Humeral head removal

To remove the humeral head, slide the anatomic head extractor between the collar of the PRIMA stem and the undersurface of the humeral head (Figure 48). Firmly tap the end of the instrument to loosen the head. It may be necessary to use more than one direction to accomplish the extraction. Using the 3.5 mm allen wrench plus T-handle with Zimmer connection remove the safety screw inside the adaptor whilst using the counter torque and the multipurpose handle to prevent load transmission. Then insert the humeral head adaptors extractor attached to the T-handle into the counter torque (Figure 49). Tighten the extractor until the disassembly operation has been completed.

Figure 48

Reverse insert removal

To remove the reverse insert from the PRIMA Stem, slide the reverse insert extractor between the collar of the PRIMA stem and the undersurface of the reverse insert. Firmly tap the end of the instrument to loosen the insert (Figure 50). For the removal of the glenoid component refer to the related surgical technique.

Figure 49

Figure 50

PRIMA Stem Surgical technique

PRIMA Stem removal

Glenoid components removal For the removal of the glenoid component refer to the SMR Surgical Techniques. In case of revision of the SMR TT Augmented 360 Metal Back and SMR TT Metal Back, refer to the surgical steps showed in the related surgical techniques.

If necessary to remove the PRIMA Stem, screw the stopper for removal reamer into the PRIMA stem (Figure 51). Select the removal reamer according to the implanted size and attach it to the reamer shaft. Introduce the reamer onto the stopper and proceed with the reaming of the bone in the proximal area (Figure 52). A small osteotome may be gently inserted along the length of the PRMIA stem through the windows in the metaphyseal portion of the prosthesis at the surgeon’s discretion. Then remove the PRIMA stem by securing the positioning handle to the prosthesis and back slapping gently with a mallet.

Figure 51

Figure 52

Conversion from Anatomic to Reverse

Note. The conversion of the implant must be performed only in case of good stability of the implanted PRIMA Stem.

Humeral side trialing Expose the humerus and select the trial reverse insert according to the implanted 40 mm or 44 mm glenosphere and insert it into the PRIMA stem as described on page 26 of the PRIMA surgical technique (Figure 41). Reduce the implant to verify the shoulder tensioning and address any laxity by replacing with the next liner size.

Removal of the humeral head and adaptor Remove the humeral head and the adaptor as described on page 29 of the PRIMA surgical technique. If no metal back glenoid has been implanted previously, proceed with the glenoid preparation as described in the SMR surgical technique.

Insertion of the definitive components

Open the packaging of the reverse insert that was selected during the trial reduction. Clean the PRIMA Stem and insert the final reverse insert as described at page 28 (Figure 46). Refer to the SMR surgical technique (SMR Metal Back, SMR Axioma TT Metal Back, SMR TT 360 Augmented Glenoid and SMR TT Hybrid Glenoid reverse baseplate) for the glenoid implantation. Finally reduce the shoulder joint.

Previous glenoid implant

Remove the anatomical component on the glenoid side as described in the SMR surgical technique.

Figure 53

Figure 54

PRIMA Stem Annex

Annex 1: Measurement chart

PRIMA Stem

LENGHT (mm)

PROXIMAL DIA (mm)

SIZE

66.0

1357.14.028

66.7

1357.14.030

67.4

1357.14.032

68.1

1357.14.034

68.9

1357.14.036

PRIMA REVERSE INSERTS 40mm

THICKNESS (mm)

OFFSET (mm)

1367.09.200 SHORT 0°

1367.09.203 MEDIUM 0°

1367.09.206 LONG 0°

1367.09.270 SHORT 7°

1367.09.273 MEDIUM 7°

1367.09.276 LONG 7°

1367.09.403 MEDIUM 0° 3mm Offset 1367.09.406 LONG 0° 3mm Offset

PRIMA REVERSE INSERTS 44mm

THICKNESS (mm)

OFFSET (mm)

1367.09.300 SHORT 0°

1367.09.303 MEDIUM 0°

1367.09.306 LONG 0°

1367.09.370 SHORT 7°

1367.09.373 MEDIUM 7°

1367.09.376 LONG 7°

1367.09.503 MEDIUM 0° 3mm Offset 1367.09.506 LONG 0° 3mm Offset

PRIMA HUMERAL HEAD ADAPTOR WITH SCREW ECCENTRICITY (mm) 1367.15.700 neutral 1367.15.702 +2 eccentrical 1367.15.704 +4 eccentrical 1367.15.706 +6 eccentrical

PRIMA Stem Instrument set

9013.68.000 PRIMA General and Reverse Set 1/2 Ref. Code Description

Qty.

Sickle

A68

9013.50.305

Cutting Jig Connector

B68

9013.55.010

Extracting Pliers for Reverse Trial Liners

C68

9013.60.101

Humeral Starting Awl

D68

9013.67.001

Guide for Resection Jig

E68

9013.67.005

Humeral Intramedullary Rod

F68

9013.67.015

Checking Rod

G68

9013.67.016

Anatomic Resection Jig

H68

9013.67.020

Cutting Template

I68

9013.67.025

Alignment Rod

J68

9013.67.028

Humeral Plate Small

K68

9013.67.030

Humeral Plate Medium

K68

9013.67.031

Humeral Plate Large

K68

9013.67.032

Humeral Cover Small

L68

9013.67.035

Humeral Cover Medium

L68

9013.67.036

Humeral Cover Large

L68

9013.67.037

Pin Dia. 3x100mm

M68

9013.67.075

Metaphyseal K-Wire

N68

9013.67.080

Reamer Shaft

O68

9013.67.100

Proximal Reamer #1

P68

9013.67.101

Proximal Reamer #2

P68

9013.67.102

Proximal Reamer #3

P68

9013.67.103

Proximal Reamer #4

P68

9013.67.104

Proximal Reamer #5

P68

9013.67.105

Trial Stem #1

Q68

9013.67.121

Trial Stem #2

Q68

9013.67.122

Trial Stem #3

Q68

9013.67.123

Trial Stem #4

Q68

9013.67.124

Trial Stem #5

Q68

9013.67.125

Impactor

R68

9013.67.140

Impactor Adaptor #1

S68

9013.67.141

Impactor Adaptor #2

S68

9013.67.142

Impactor Adaptor #3

S68

9013.67.143

Impactor Adaptor #4

S68

9013.67.144

Impactor Adaptor #5

S68

9013.67.145

Spike Bushing

T68

9013.67.160

Metaphyseal Size Ring #1

U68

9013.67.161

Metaphyseal Size Ring #2

U68

9013.67.162

Metaphyseal Size Ring #3

U68

9013.67.163

Metaphyseal Size Ring #4

U68

9013.67.164

Metaphyseal Size Ring #5

U68

9013.67.165

Humeral Head Impactor

V68

9013.67.191

Reverse Insert Pusher

W68

9013.67.192

9013.68.000 PRIMA General and Reverse Set 2/2 Ref. Code Description

Qty.

Trial Insert Dia.40mm SHORT 0°

X68

9013.67.200

Trial Insert Dia.40mm MEDIUM 0°

X68

9013.67.201

Trial Insert Dia.40mm LONG 0°

X68

9013.67.202

Trial Insert Dia.40mm SHORT 7°

X68

9013.67.203

Trial Insert Dia.40mm MEDIUM 7°

X68

9013.67.204

Trial Insert Dia.40mm LONG 7°

X68

9013.67.205

Trial Insert Dia.40mm MEDIUM 0° 3mm Offset

X68

9013.67.206

Trial Insert Dia.40mm LONG 0° 3mm Offset

X68

9013.67.207

Trial Insert Dia.44mm SHORT 0°

X68

9013.67.208

Trial Insert Dia.44mm MEDIUM 0°

X68

9013.67.209

Trial Insert Dia.44mm LONG 0°

X68

9013.67.210

Trial Insert Dia.44mm SHORT 7°

X68

9013.67.211

Trial Insert Dia.44mm MEDIUM 7°

X68

9013.67.212

Trial Insert Dia.44mm LONG 7°

X68

9013.67.213

Trial Insert Dia.44mm MEDIUM 0° 3mm Offset

X68

9013.67.214

Trial Insert Dia.44mm LONG 0° 3mm Offset

X68

9013.67.215

Compactor & Positioning Handle

Y68

9013.67.420

Proximal Compactor #1

Z68

9013.67.611

Proximal Compactor #2

Z68

9013.67.612

Proximal Compactor #3

Z68

9013.67.613

Proximal Compactor #4

Z68

9013.67.614

Proximal Compactor #5

Z68

9013.67.615

Instrument Tray

9013.68.990

Powered Pin Driver

Z68 Γ 68 Δ 68 Θ 68

9095.11.120

T-Handle Zimmer Connection

9095.11.203

T-Handle with AO Connection

9095.11.206

Namba Shoulder Slide

9095.11.911

PRIMA Stem Annex

9013.69.000 PRIMA Anatomic Set Ref. Code Description

Qty.

Trial Humeral Head Dia. 40mm

A69

9013.22.405

Trial Humeral Head Dia. 42mm

A69

9013.22.425

Trial Humeral Head Dia. 44mm

A69

9013.22.445

Trial Humeral Head Dia.46mm

A69

9013.22.465

Trial Humeral Head Dia. 48mm

A69

9013.22.485

Trial Humeral Head Dia. 50mm

A69

9013.22.505

Trial Humeral Head Dia. 52mm

A69

9013.22.525

Trial Humeral Head Dia. 54mm

A69

9013.22.545

Trial Adaptor Taper Neutral

B69

9013.30.011

Trial Adaptor Taper Ecc. 2mm

C69

9013.30.016

Trial Adaptor Taper Ecc. 4mm

C69

9013.30.021

Trial Heads Ecc. 6mm Adaptor

D69

9013.30.026

Anatomical Trial Adaptor

E69

9013.67.180

Counter-torque Handle for Anatomical Adaptors

F69

9013.67.190

Humeral Head Adaptors Extractor

G69

9013.67.360

Anatomic Head Extractor

H69

9013.67.500

Instrument Tray

9013.69.990

Extracting Plier for Trial Adaptors

I69

9066.35.610

Screwdriver Shaft

J69

9095.10.228

Multipurpose Handle

G69

9095.11.255

9013.74.000 PRIMA Stem Revision Set Ref. Code Description

Qty.

Metaphyseal Removal Reamer #1

C74

9013.67.401

Metaphyseal Removal Reamer #2

C74

9013.67.402

Metaphyseal Removal Reamer #3

C74

9013.67.403

Metaphyseal Removal Reamer #4

C74

9013.67.404

Metaphyseal Removal Reamer #5

C74

9013.67.405

Metaphyseal Removal Reamer Stopper

D74

9013.67.410

Reverse Insert / Tray Assembly Extractor

E74

9013.67.501

Instrument Tray

9013.74.990

PRIMA Stem Annex

9013.92.000 SMR Reverse HP & Lateralized Glen. Set Ref. Code Description

Qty.

Reverse Trial Liner Dia. 44mm Short

A92

9013.62.011

Reverse Trial Liner Dia. 44mm Medium

A92

9013.62.016

Reverse Trial Liner Dia. 44mm Long

A92

9013.62.021

Reverse Trial Liner LAT. Dia. 44mm Medium

A92

9013.62.116

Reverse Trial Liner LAT. Dia. 44mm Long

A92

9013.62.121

Reverse Trial Liner Dia. 40mm Short

A92

9013.65.011

Reverse Trial Liner Dia. 40mm Medium

A92

9013.65.016

Reverse Trial Liner Dia. 40mm Long

A92

9013.65.021

Reverse Trial Liner LAT. Dia. 40mm Medium

A92

9013.65.116

Reverse Trial Liner LAT. Dia. 40mm Long

A92

9013.65.121

Guide Screw for Trial Glenosphere Small-R

B92

9013.74.105

Guide Screw for Trial Glenosphere

B92

9013.74.120

Glenosphere Impactor

C92

9013.74.144

Glenosphere Extractor

D92

9013.74.145

Trial Glenosphere Lat. +2mm Dia. 36mm

E92

9013.74.312

Trial Glenosphere Lat. +4mm Dia. 36mm

E92

9013.74.314

Trial Glenosphere Dia.40mm

E92

9013.74.402

Trial Glenosphere Dia.44mm

E92

9013.74.441

Trial Glenosphere Dia. 44mm Corrective

E92

9013.74.445

Trial Glenosphere Lat. +2mm Dia. 40mm

E92

9013.74.502

Trial Glenosphere Lat. +4mm Dia. 40mm

E92

9013.74.504

Trial Glenosphere Lat. +2mm Dia. 44mm

E92

9013.74.542

Inserter for Glenosphere Plug

F92

9013.74.606

Dia. 40-44mm Glenosphere Orienter LEFT

G92

9013.74.651

Dia. 40-44mm Glenosphere Orienter RIGHT

G92

9013.74.652

Instrument Tray

9013.92.990

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