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

Model Number	EQUINOXE REVERSE 42MM GLENOSPHERE
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately four years post initial right tsa, the 75 y/o male patient complained of pain and poly failure.Patient was not revised to exactech devices.There was no breakage of device or surgical delay/prolongation reported.Patient last known to be in stable condition following the event.Images received.The device is not available for evaluation due to hospital will not release due to chain of command.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately four years post initial right tsa, the male patient complained of pain and poly failure.Patient was not revised to exactech devices.There was no breakage of device or surgical delay/prolongation reported.Patient last known to be in stable condition following the event.Images received.The device is not available for evaluation due to hospital will not release due to chain of command.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b1, b2, b5, d8, g1, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The revision reported was likely the result of pain and prosthesis wear of the humeral liner and an unknown metal component.It remains unclear which metal component was involved with the observed metal debris.The cause of the humeral liner wear cannot be determined but may be related to impingement of the liner on native glenoid bone and/or or instability of the shoulder joint resulting in edge loading of the glenosphere on the humeral liner.However, the series of events cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and no radiographs or relevant clinical information was provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18395070
• Report Number: 1038671-2023-03053
• Device Sequence Number: 2673462
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 12/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EQUINOXE REVERSE 42MM GLENOSPHERE
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2019
• 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: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM (3).; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM.; EQ REV LOCKING SCREW.; EQ REVERSE TORQUE DEFINING SCREW KIT.; EQUINOXE REVERSE 42MM HUMERAL LINER +2.5.; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0.; EQUINOXE, HUMERAL STEM PRIMARY.; GLND KWIRE.; RS GLENOID PLATE SUP AUG, 10 DEG.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male