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

Catalog Number	320-20-00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-30-06 - equinoxe preserve stem 6mm: unknown 322-40-00 - 145-deg pe 40mm hum liner +0: (b)(6); 320-32-40 - exp glen, 40mm, for small reverse: (b)(6); 320-55-99 - csb glenosphere screw: (b)(6;) 320-55-01 - centl scr baseple standard: (b)(6); 320-55-40 - cent scr basepl cent scr, 40mm: (b)(6) should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported via a clinical study, that a 69 yo male patient, who had a rtsa, underwent a revision procedure due to disassociation of humeral plate.The replicator tray screw stripped and backed out of the cylindrical bore humeral tray.The tray and liner were replaced.The study indicates it was definitely related to the devices and the procedure.The outcome states resolved.No further information.This is 1 of 2 events for this patient.

• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24624246
• Report Number: 1038671-2026-00289
• Device Sequence Number: 21099473
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: 320-20-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White