MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-10-00
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-30-09 - equinoxe preserve stem 9mm (b)(6).320-06-42 - glenosphere 42mm (b)(6).320-15-01 - eq rev glenoid plate (b)(6).320-15-05 - eq rev locking screw (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
As reported, approximately 4 years and 1 month post the initial left reverse total shoulder arthroplasty, the patient complained of pain and was revised due to poly disassociation.Metal on metal wear and debris was found during the revision.The poly was recalled.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24712298
• Report Number: 1038671-2026-00345
• Device Sequence Number: 5989230
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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): 03/27/2026

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: 320-10-00
• 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: 03/13/2026
• Initial Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 10/27/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male