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

Catalog Number	320-20-00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 320-10-05 - equinoxe reverse tray adapter plate tray +5, (b)(6), 320-15-04 - rs glenoid plate post aug, 8 deg, right, (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere, (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit, (b)(6), 300-30-08 - equinoxe preserve stem 8mm, (b)(6), 315-35-00 - glnd kwire, (b)(6), 315-35-00 - glnd kwire, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-20-00 - eq reverse torque defining screw kit, (b)(6), 320-38-00 - equinoxe reverse 38mm humeral liner +0, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.
Event or Problem Description
It was reported that a 43 yo male patient, who had a competitor¿s right shoulder anatomic devices converted to a reverse on (b)(6) 2022, underwent a revision procedure on (b)6) 2025, approximately 2 years 4 months post the reverse procedure.The patient was reaching behind their knee and their shoulder gave way.Intraoperative it was determined the torque defining screw wasn't in the stem, the tray was posterior to the glenosphere, and the liner was in place.The liner, adaptor tray and screw kit were revised to same company¿s devices.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted devices are not available for return.The patient requested them.Device images were provided.No further information.
Event or Problem Description
This is 1 of 2 reports for this event.See mdr# 1038671-2025-00294.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The reason for the revision is likely due to the disassembly of the torque defining screw and thus the humeral tray and liner assembly from the humeral stem.Potential contributions may include patient conditions, incomplete seating or forces on the underside of the humeral tray at the time of implantation secondary to unintended contact with protruding bone, or an issue with insufficient application of torque or cross-threading of the screw during assembly.However, this cannot be confirmed as not all involved devices were returned and the view in the provided immediate post-operative radiograph does not provide sufficient visibility.H6 - investigation type, findings, conclusion.The following sections were corrected: h6 - 1924 failure of implant no longer applies.H6 - investigation type, findings, conclusion - prior coding no longer applies.

• 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: 21173016
• Report Number: 1038671-2025-00291
• Device Sequence Number: 4538718
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2025

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: 320-20-00
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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: 43 YR
• Patient Sex: Male