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

Catalog Number	204-04-22
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number: 1038671-2023-00662, 1038671-2025-00398.D10 concomitant devices: (b)(6) 204-32-01 - fluted stem extension 11l x 12 mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00662, 1038671-2025-00398.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.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
It was reported via legal documentation that approximately 94 months after a left total knee replacement procedure, the patient has experienced prosthesis wear, chronic left knee pain and recent increased left knee pain, metal related pathology, osteolysis, synovitis, implant pain, scar tissue, joint laxity, loss of range of motion implant.Revision operative reports were provided.Post operative diagnosis noted failed left knee replacement.Intraoperatively the surgeon noted that upon entry of the joint, extensive grey/black synovium was observed throughout the joint consistent with metallosis reaction.The surgeon noted the femoral and tibial components were well fixed and not loose but observed evidence of several underlying areas of osteolysis on both components.The patellar button was noted to have some delamination of the polyethylene but mostly intact with only slight deformation and it was elected to retain it in place.No medical or surgical interventions were reported.No additional information is available.Patient was transferred to recovery room in stable condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b, c, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, dislocation, and loss of range of motion or due to inclusion of the polyethylene in the packaging recall.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/2T, 2F/2T
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21232508
• Report Number: 1038671-2025-00399
• Device Sequence Number: 8537310
• Product Code: JWH
• UDI-Device Identifier: 10885862047632
• UDI-Public: 10885862047632
• 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: 2010
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2015
• Device Catalogue Number: 204-04-22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/25/2025
• Date Device Manufactured: 04/26/2010
• 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: 52 YR
• Patient Sex: Female