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

Catalog Number	314-13-13
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Arthropathy (4894)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 310-01-47 - equinoxe, humeral head short, 47mm (beta) 2946854.300-01-13 - equinoxe, humeral stem primary, press fit 13mm 2979013.300-20-02 - equinox square torque define screw drive kit 3534168.300-10-45 - equinoxe replicator plate 4.5mm o/s 3641528.
Event or Problem Description
The glenoid component was not broken or loose.I'm guessing the patient's rc had deteriorated and was unstable, or maybe the nine-year-old poly was starting to wear.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been due to prosthesis wear, instability and/or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear and instability could not be confirmed.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.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, BETA
• 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 ct; gainesville FL
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17859771
• Report Number: 1038671-2023-02440
• Device Sequence Number: 5909042
• Product Code: KWT
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2018
• Device Catalogue Number: 314-13-13
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2013
• 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 H10.
• Patient Age: 60 YR
• Patient Sex: Male