MAUDE Adverse Event Report: EXACTECH, INC. TRAPEZOID TIBIAL TRAY SZ 1F/1T, 2F/1T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-04-21
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 200-62-13 - cr tibial insert sz 2, 13mm, slope +; (b)(6) 200-02-32 - three peg patella 32mm; (b)(6) 230-03-02 - optetrak asy, cr cemented femoral, sz 2, multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-01902, 1038671-2024-01903.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
It was reported via legal documentation that approximately 143 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, failure of polyethylene liner, osteolysis, aseptic loosening.Revision operative report was provided, and findings conclude that patient was negative for infection.Polyethylene liner was worn and separated from the tibial plate place and evidence of metal-on-metal articulation after the polyethylene failure, as well as aseptic loosening and osteolysis of the femoral and tibial components.There was a central area of bone loss in the tibia and a fairly large medial femoral condyle bone loss as well as central bone loss in the femur.No further issues or complications were reported.No additional information is available.
Event or Problem Description
It was reported via legal documentation that approximately 143 months after a right total knee replacement procedure, the patient underwent a revision procedure address pain, swelling and instability due to aseptic loosening, osteolysis and failure of the polyethylene liner.A revision operative report was provided.Intraoperatively, the surgeon observed black stained tissue, and the polyethylene was noted to be completely eroded through and had separated from the tibial base plate.The blackened tar tissue due to the metal-on-metal articulation after the polyethylene failure was removed.The femoral and tibial components were removed, and it was noted that there was a central area of bone loss in the tibia and a fairly large medial femoral condyle bone loss as well as central bone loss in the femur.No medical or surgical intervention was noted.No additional information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h11.The following sections were corrected: b5, h6.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.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 prosthesis wear, instability, disassembly, and femoral loosening, as reported, or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRAPEZOID TIBIAL TRAY SZ 1F/1T, 2F/1T
• 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 ; gainesville, FL 32653
• MDR Report Key: 20854140
• Report Number: 1038671-2024-04636
• Device Sequence Number: 8776744
• Product Code: JWH
• UDI-Device Identifier: 10885862047625
• UDI-Public: 10885862047625
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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 Expiration Date: 08/12/2014
• Device Catalogue Number: 204-04-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2009
• 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: 62 YR
• Patient Sex: Female