MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-01-42
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
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.D10: eq rev locking screw (cat# 320-15-05 / serial # (b)(6).
Event or Problem Description
As reported, approximately three years post the initial right total shoulder arthroplasty, the patient's poly dissociated at an unknown point, cause unknown.After dissection, it was noted that the motion of the glenosphere without a poly in place had worn away the humeral tray and locking screw.All components above were removed and replaced with new implants.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 revision reported was likely the result of humeral liner disassociation and subsequent abnormal articulation between the glenosphere and humeral tray leading to full thickness wear of the humeral tray and fracture of the locking screw.The reason for the disassociation cannot be determined but may be the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.

• Brand Name: EQUINOXE REVERSE 42MM GLENOSPHERE
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21402470
• Report Number: 1038671-2025-00998
• Device Sequence Number: 8215229
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 06/19/2025

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 Catalogue Number: 320-01-42
• 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: 05/21/2023
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 03/26/2020
• 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 Age: 78 YR
• Patient Sex: Male