MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-10-05
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: serial #: (b)(6), category #: 320-42-13 - 145-deg pe 42mm const hum liner +2.5, serial #: (b)(6), category #: 320-10-05 - equinoxe reverse tray adapter plate tray +5, serial #: (b)(6), category #: 320-08-42 - glenosphere exp 42mm +4mm offset, serial #: (b)(6), category #: 320-15-05 - eq rev locking screw, serial #: (b)(6), category #: 320-20-00 - eq reverse torque defining screw kit.The revision reported may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and images/radiographs were unable to be obtained.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported, approximately 10 months post op the initial left tsa, this patient was revised due to the humeral poly dissociating from humeral tray.Patient was last known to be in stable condition following the event.No information is forth coming at this time.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• 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
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL
• MDR Report Key: 24379050
• Report Number: 1038671-2026-00169
• Device Sequence Number: 18711895
• Product Code: KWT
• UDI-Device Identifier: 10885862086426
• UDI-Public: 10885862086426
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 320-10-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 06/28/2021
• 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): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male