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

Catalog Number	320-38-00
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Joint Impingement (4834)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 320-01-38 equinoxe reverse 38mm glenosphere.(b)(6) 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.(b)(6) 320-15-04 - rs glenoid plate r post aug, 8 deg, right.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) 531-20-00 - shldr gps rvrs drill kit.(b)(6) 531-78-20 - shouldr gps hex pins kit (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that female patient who had an initial reverse shoulder implanted on the right side, underwent a revision procedure approximately 5 years post the initial procedure.The patient was doing well until she had spinal fusion surgery in (b)(6) 2025.The surgeon stated the patient had to push herself in and out of bed a lot but had no memory of an exact instance where the poly may have popped out of the humeral tray.Imaging showed tray and sphere articulation, so it was clear the liner had disassociated.Revision occurred and the polyethylene was in fact disassociated with the humeral tray posteriorly.It was pulled out and observation indicated there was some wear on the inferior lip of the poly due to potential scapular notching and on the outside posterior lip portion of the liner, likely due to floating in the joint and rubbing on an adjacent structure.There was no noticeable poly wear on the articulating area of it.The tray was removed, as well as the glenosphere locking screw and glenosphere.The surgeon wound up upsizing to a 42 sphere and constrained liner for additional stability.There were no device breakages or surgical delays 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 as the hospital won¿t release them.Device images were provided.No further information.

• 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 ; 3525541928
• MDR Report Key: 21971638
• Report Number: 1038671-2025-01979
• Device Sequence Number: 12887618
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 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: 04/03/2024
• Device Catalogue Number: 320-38-00
• 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: 04/14/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female