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

Catalog Number	320-42-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm; (b)(6), 320-02-42 - rs expanded glenosphere 42mm, +4mm offset; (b)(6), 320-15-05 - eq rev locking screw; (b)(6), 320-15-06 - rs glenoid plate +10mm cage peg; (b)(6), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm; (b)(6), 531-78-20 - shouldr gps hex pins kit; (b)(6), a10012 - gps implant kit v2.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 64 yo male patient, whose left shoulder was initially implanted in (b)(6) 2024, and who was revised in (b)(6) 2024, due to the shoulder dislocating, underwent a second revision on (b)(6) 2025.The patient presented with component dissociation.The surgeon extracted and changed the humeral liner.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were available.The explanted product is not available for return.It was disposed of by the customer.No device images were available.No further information.September revision reported under mdr# 1038671-2024-03725.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3 - the revision reported was likely the result of disassembly between the humeral liner and humeral tray.However, this cannot be confirmed and potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the reported disassembly of the humeral liner cannot be determined as the devices were not returned for evaluation and images/radiographs were not provided.H6 - clinical and investigation coding added.The following sections were corrected: h6 -clinical code 2374 investigation type 4118, findings 3233, conclusion 11 no longer applies should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21398743
• Report Number: 1038671-2025-00968
• Device Sequence Number: 21164275
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/23/2025

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 Catalogue Number: 320-42-13
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2024
• 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: 64 YR
• Patient Sex: Male