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

Catalog Number	314-13-02
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4.4 years post the initial left total shoulder arthroplasty, the patient had all implants explanted due to stem loosening.The patient was revised to competitor devices.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d10: - equinoxe replicator plate 4.5mm o/s (cat# 300-10-45 / serial# (b)(6)).- equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(6)).- equinoxe, humeral head short, 44mm (alpha) (cat# 310-01-44 / serial# (b)(6)).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d.The revision reported was likely the result of prothesis wear.Additional reasons for the reported revision may be humeral loosening and the inclusion of the polyethylene in the packaging recall.However, the reported humeral loosening could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information was not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE CAGE GLENOID SMALL, ALPHA
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 21468572
• Report Number: 1038671-2025-01238
• Device Sequence Number: 15617981
• Product Code: KWS
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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: 08/13/2023
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 10/21/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 02/26/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 H11.; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female