MAUDE Adverse Event Report: Exactech, Inc. EQUINOXE GLENOID, PEGGED BETA, MEDIUM; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Catalog Number	314-02-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right anatomic shoulder replacement.Subsequently, the patient began experiencing pain and dislocation, the glenoid component was reported to have worn down.The surgeon removed the exactech implants and converted the patient to a reverse total shoulder replacement (tsr) using implants from another manufacturer.The patient was last known to be in stable condition following the event.No further information is available.

• Brand Name: EQUINOXE GLENOID, PEGGED BETA, MEDIUM
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; +1(352)377-1140
• MDR Report Key: 50569708
• Report Number: 1038671-2026-01131
• Device Sequence Number: 13382719
• Product Code: KWS
• UDI-Device Identifier: 10885862657800
• UDI-Public: 10885862657800
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 09/02/2026

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: 06/27/2021
• Device Catalogue Number: 314-02-13
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 07/05/2016
• 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
• Patient Sex: Male