MAUDE Adverse Event Report: EXACTECH, INC. TRAPEZOID TIBIAL TRAY SZ 4F/5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-04-45
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was likely due to prosthesis wear of the insert and prosthesis wear and fracture of the patella.Prosthesis wear of the tibial insert may have been due to instability, orientation of the components, patient related conditions, third body wear, incomplete seating of the insert, or any combination of these possibilities.It also appears that the insert disassembled from the tibial tray.Based on the information provided, the sequence of events could not be determined.It is unclear if the disassociation of the insert led to prosthesis wear and/or if the prosthesis wear may have led to the disassociation of the insert.Additionally, the insert was packaged in a nonconforming vacuum bag for over five years, which may have contributed to the reported wear.D10: ps cem.Femoral size 4, right (cat# 234-03-04 / (b)(6)).
Event or Problem Description
As reported, approximately ten years post the initial right total knee arthroplasty, the patient had a revision due to a massive osteolysis issue due to poly wear.All implants were removed.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: TRAPEZOID TIBIAL TRAY SZ 4F/5T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21937201
• Report Number: 1038671-2025-01945
• Device Sequence Number: 7884336
• Product Code: JWH
• UDI-Device Identifier: 10885862047700
• UDI-Public: 10885862047700
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2016
• Device Catalogue Number: 204-04-45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 80 KG