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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 years post the initial left total shoulder arthroplasty, the patient was revised due to poly disassociation.The patient was revised to competitor devices.There were parts/fragments that were removed from the patient.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10: equinoxe humeral stem primary press fit 12mm (cat# 300-01-12 / serial# (b)(6), equinoxe reverse 46mm glenosphere (cat# 320-01-46 / serial# (b)(6), eq rev glenoid plate (cat# 320-15-01 / serial# (b)(6), eq rev locking screw (cat#320-15-05 / serial# (b)(6), eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6), eq rev compress screw lck cap kit, 4.5 x 42mm (cat# 320-20-42 / serial# (b)(6), eq rev compress screw lck cap kit, 4.5 x 46mm (cat# 320-20-46 / serial# (b)(6), eq rev compress screw lck cap kit, 4.5 x 46mm (cat# 320-20-46 / serial# (b)(6), equinoxe reverse shoulder drill kit (cat# 321-20-00 / serial# (b)(6).No device was returned for evaluation; the reported event was confirmed by review of photographs of the device.The review identified that the explanted liner appears severely worn, which was likely t he result of floating free in the joint space.The black discoloration appears consistent with metal debris particles becoming embedded in the polyethylene likely due to metal-on-metal contact between the glenosphere and humeral tray after the disassociation occurred, which can be seen on the radiograph.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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: katy priest ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25230274
• Report Number: 1038671-2026-00631
• Device Sequence Number: 12044590
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2023
• 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): 05/20/2026

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: 01/13/2023
• Initial Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 01/03/2020
• 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; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male