MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, ALPHA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-03
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-01-11 - equi, hum stem primary, press fit 11mm: (b)(6).300-10-45 - equi replicator plate 4.5mm o/s: (b)(6).300-20-02 - equi sq torque define screw drive kit: (b)(6).310-01-47 - equi, hum head short, 47mm (beta): (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 71 yo male patient who had a right tsa, underwent a revision procedure.The shoulder was revised due to increased pain and reduced rom over the last 12 months.On x-ray there was evidence of lysis of both humeral and glenoid components.All implants were removed as infection could not be ruled out.Testing confirmed that all samples were negative except one - staph epi on enriched growth.Significant glenoid wear was noted, likely requiring a custom glenoid.The cuff was still in tact on the day of the revision.A cement spacer is now insitu.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are available for return.Device images were provided.No further information.This is 1 of 2 reports for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11.The complaint device was evaluated, and the reported event was confirmed.The evaluation identified the glenoid component central cage appears to have sheared off the glenoid body and subsequently worn a hole through the articular surface.Commonly associated with off-axis drilling of the peg holes during implantation and/or improper initial seating of the glenoid component.The end of the center cage appears slanted, consistent with wear of the component.A review of complaint history determined that no further action is required as no trends were identified.The revision reported was likely the result of fracture of the central cage and peripheral peg leading to the subsequent wear and cracking of the glenoid component.Other contributing factors to the event could have been the reported loss of range of motion and infection.The cause of the fracture cannot be conclusively determined but may be related to off-axis drilling of the peripheral peg holes during implantation and/or incomplete seating of the implant resulting in a rocking horse effect.However, loss of range of motion, infection, and the series of events could not be confirmed fand potential contributions of user or patient-related considerations to the event could not be assessed as radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, ALPHA
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 23641080
• Report Number: 1038671-2025-03446
• Device Sequence Number: 9765813
• Product Code: KWS
• UDI-Device Identifier: 10885862657923
• UDI-Public: 10885862657923
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 01/21/2023
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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