MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID SMALL, ALPHA; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-02
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 300-10-15 - equinoxe replicator plate 1.5mm o/s; (b)(6), 300-20-02 - equinox square torque define screw drive kit; (b)(6), 300-30-06 - equinoxe preserve stem 6mm; (b)(6); 310-01-41 - equinoxe, humeral head short, 41mm (alpha).
Event or Problem Description
As reported, the 73 year old female patient had an initial right tsa on (b)(6) 2022.The patient underwent a revision of the failed anatomic shoulder arthroplasty on (b)(6) 2024.The reason for the revision was the glenoid.On x-ray it was clear the pegs had disassociated from the poly, no trauma reported, cuff still intact.Upon removal of the implant, only the superior peg remained, both posteriors were dissociated and central cage was grown in.It is worth noting the poly did not break off cleanly from the central peg and the threaded portion still contained poly.Trephine drill was used to extract.It's likely the poly was then rubbed against the cage, resulting in loss of poly.The patient was revised to a standard small baseplate, lots of glenoid bone loss, no immediate signs of infection but tissue samples were taken.6mm preserve stem retained.All parts, pieces and fragments were removed from the patient wound site.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3, h6 component code, type of investigation, investigation findings, investigation conclusions.The following sections were corrected: h6 problem code.H3: the revision reported was likely the result of prosthesis fracture, disassociation, and wear of the anatomic glenoid component.The cause of this fracture cannot be confirmed may have been due to incomplete seating of the implant and/or off-axis drilling of the peg holes during implantation resulting in a rocking horse effect, dissociation of peripheral pegs, and prosthesis wear.However, this cannot be confirmed because the component was not returned for evaluation and no radiographs were provided.

• Brand Name: EQUINOXE CAGE GLENOID SMALL, ALPHA
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19297591
• Report Number: 1038671-2024-01200
• Device Sequence Number: 5855488
• Product Code: KWT
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2024
• Device Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female