MAUDE Adverse Event Report: EXACTECH, INC. TRAPEZOID TIBIAL TRAY SZ 3F/3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-04-33
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, it was reported that the patient experienced pain, swelling, osteolysis and prosthesis wear.As a result, the patient underwent a right knee revision approximately 13 years after initial implantation.Patient was last known to be in stable condition.No further information available.
Additional Manufacturer Narrative
The revision reported was likely the result of wear of the tibial insert and suspected aseptic (non-infected) loosening.The cause and extent of the prosthesis wear cannot be determined because the revised components were not returned for evaluation and no x-rays or photographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.D10: insert, constrained condylar size3 9mm, cat#: 208-23-09, sn: (b)(6).Patella, three peg 35mm, cat#: 200-02-35, sn: (b)(6).Extension, femoral and tibialfluted stem 12mm od x11mm l, cat#: 204-32-01, sn: (b)(6).Component, femur non¿modular cck size 3, cat#: 210-01-03, sn: (b)(6).

• Brand Name: TRAPEZOID TIBIAL TRAY SZ 3F/3T
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24680658
• Report Number: 1038671-2026-00321
• Device Sequence Number: 15962979
• Product Code: JWH
• UDI-Device Identifier: 10885862047663
• UDI-Public: 10885862047663
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• 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): 03/24/2026

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: 03/23/2014
• Device Catalogue Number: 204-04-33
• 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: 09/23/2022
• Initial Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 03/25/2009
• 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: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male