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 Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Aseptic loosening (4883)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had an initial right total knee arthroplasty, subsequently, six (6) years, seven (7) months later, the patient experienced increasing pain.As a result, the patient underwent a revision procedure.A revision operative report was provided.Post operative diagnosis noted aseptic (non-infected) loosening of the tibial with large metaphyseal uncontained bony defect and polyethylene wear.Intraoperatively, synovitis and scar tissue were observed.The patient was taken to the pacu in stable condition.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6), 234-03-02 - optetrak asy, ps cemented femoral, sz 2, (b)(6), 200-02-35 - three peg patella 35mm, (b)(6), 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t, (b)(6), 204-22-11 - ps tibial inserts sz 2, 11mm.H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01941.The revision reported in this event may have been the result of polyethylene wear and aseptic loosening as stated in the operative notes.The aseptic (non-infected) tibial loosening may have been the result of both patient-related conditions and insufficient bonds between the tibial tray and the bone.The extent and root cause of the polyethylene wear cannot be determined as the explanted devices were not returned for evaluation, and radiographs / photographs 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 ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24274141
• Report Number: 1038671-2026-00119
• Device Sequence Number: 15967311
• Product Code: JWH
• UDI-Device Identifier: 10885862047632
• UDI-Public: 10885862047632
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• 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
• Report Date (Section B): 02/05/2026

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: 10/27/2015
• Device Catalogue Number: 204-04-22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 10/28/2010
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female