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

Catalog Number	320-10-00
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Laxity (4526); Metal Related Pathology (4530)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, who had a left tsa, underwent a revision procedure.The patient presented with an unstable shoulder and required surgery to reduce the joint stability.During the case, it became clear of what the issue was as the poly was floating around in the joint space and was not locked into the humeral tray.There was lots of black tissue and metallosis surrounding the implants.The 38mm glenosphere and glenosphere locking screw were explanted along with the 38mm +2.5mm constrained liner, +0mm humeral tray and torque screw.They upsized and reimplanted a 42mm glenosphere and glenosphere locking screw, and a 42mm +2.5mm liner, +0mm humeral tray and torque screw.The glenoid baseplate and humeral stem were left in as they were well fixed.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.X-ray images were provided.The explanted devices are not available for return as the hospital won't release them.Device images were provided.No further information.This is 1 of 3 reports for this event.

• Brand Name: EQUINOXE
• 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 ct; gainseville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 court; gainseville, FL 32653 ; 3523771140
• MDR Report Key: 25479814
• Report Number: 1038671-2026-00765
• Device Sequence Number: 14813776
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 06/24/2026

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 Catalogue Number: 320-10-00
• 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: 05/21/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male