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

Catalog Number	314-13-14
Medical Device Problem Codes	Loss of Osseointegration (2408); Lack of Effect (4065)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial anatomic total shoulder replacement on the left side.Subsequently, the patient experienced glenoid loosening, glenoid bone loss and loss of range of motion.As a result, approximately, nine years and ten months post-surgery, the patient underwent a revision.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.
Additional Manufacturer Narrative
D10: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm: sn# (b)(6), 300-10-15 - equinoxe replicator plate 1.5mm o/s: sn# (b)(6), 300-20-02 - equinox square torque define screw drive kit: sn# (b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta): sn# (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• 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: 23581415
• Report Number: 1038671-2025-03360
• Device Sequence Number: 9505315
• Product Code: KWS
• UDI-Device Identifier: 10885862657947
• UDI-Public: 10885862657947
• 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): 11/18/2025

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: 11/29/2020
• Device Catalogue Number: 314-13-14
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 12/02/2015
• 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