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

Catalog Number	314-13-04
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-10-45 - equinoxe replicator plate 4.5mm o/s: sn#: (b)(6).300-20-02 - equinox square torque define screw drive kit: sn#: (b)(6).300-30-08 - equinoxe preserve stem 8mm: sn#: (b)(6).310-01-44 - equinoxe, humeral head short, 44mm (alpha): sn#: (b)(6).Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial anatomic total shoulder replacement on the right side.Subsequently, the patient experienced severe bone loss and a fractured polyethylene glenoid implant.As a result, an unknown amount of time post-surgery, the patient underwent a revision.All pieces of the fractured polyethylene were removed from the patient.There were no surgical delays during the procedure.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available at this time.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23913548
• Report Number: 1038671-2025-03640
• Device Sequence Number: 21105545
• Product Code: KWS
• UDI-Device Identifier: 10885862172709
• UDI-Public: 10885862172709
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 12/29/2025

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 Expiration Date: 03/27/2021
• Device Catalogue Number: 314-13-04
• 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: 12/11/2025
• Initial Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 03/29/2016
• 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 Age: 66 YR
• Patient Sex: Male