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); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 94 months after a left total shoulder replacement procedure, the patient underwent a revision procedure to address pain, loss of function and osteolysis.The loss of function was not a gradual loss of function, but more of an ¿all of sudden¿ event per the report.Upon extracting hardware, the humeral head, replicator plate, and stem were all extracted without much difficulty.Moving to the glenoid side, the glenoid came out quite easily with all 3 peripheral pegs attached but the cage was not attached as it had snapped from the poly.The threaded cage extraction instrument was threaded into the cage and a slap hammer was used to remove it.All parts and pieces were removed.The cage had broken off in the glenoid but was removed in its entirety.There were some clear signs of osteolysis as the glenoid had become quite medialized.The surgeon extracted all hardware and converted to a competitor¿s devices per his plan.The patient left the operating room in stable condition.No further issues or complications were reported.X-rays were provided.The device is not available for return as the hospital kept them.Device images were provided.No additional information is available.
Additional Manufacturer Narrative
D10: concomitant devices 4332823 300-10-45 - equinoxe replicator plate 4.5mm o/s 4346005 300-20-02 - equinox square torque define screw drive kit 4474813 310-01-44 - equinoxe, humeral head short, 44mm (alpha).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely due to fracture of the glenoid component.Additionally, potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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 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: 19726286
• Report Number: 1038671-2024-02362
• Device Sequence Number: 8033619
• Product Code: KWS
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 05/06/2025

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: 06/08/2021
• Device Catalogue Number: 314-13-03
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 05/05/2025; 05/05/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 05/06/2025; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female