MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, PEGGED BETA, LARGE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-02-14
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Arthropathy (4894)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-10-15 - equinoxe replicator plate 1.5mm o/s (b)(6), 300-20-02 - equinox square torque define screw drive kit (b)(6), 310-01-50 - equinoxe, humeral head short, 50mm (beta) (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that an 88 yo male patient, who had a left primary anatomic shoulder replacement, was converted to a rtsa.The patient was happy until the cuff failed.The original stem was retained.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are not being returned but will be requested.Device images were provided.Prosthesis wear was observed.No further information.This is 1 of 2 reports for this event.

• Brand Name: EQUINOXE GLENOID, PEGGED BETA, LARGE
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 24464732
• Report Number: 1038671-2026-00205
• Device Sequence Number: 10277332
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2024
• Device Catalogue Number: 314-02-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male