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

Catalog Number	204-04-44
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: ps tibial insert size 4, 9mm (cat#204-24-09 / serial # (b)(6).Three peg patella 32mm (cat# 200-02-32/ serial # (b)(6).The revision reported was likely due to a combination of osteolysis and loosening between the patellar and tibial components and the underlying bone over the course of 11 years of implantation.Patellar maltracking may have been a contributing factor to the patellar wear and/or loosening.Unintended contact between the trochlear ridge of the femoral component during knee extension and/or third body wear may have been a contributing factor to the tibial insert damage.Patellar and tibial loosening cannot be confirmed as the devices were not available for evaluation and limited clinical information was provided.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
As reported, approximately ten years post initial right tka, the 70 y/o male patient had a revision due to loose patella, poly issues and osteolysis of the tibia.Surgeon changed the liner, patella and tibial tray and also used an extension stem.There were no parts or pieces fell into the patient wound site.Patient was last known to be in stable condition following the event.X-rays and photos received.The devices are not available for evaluation as they were discarded by the hospital.No other patient information/medical history reported.

• Brand Name: TRAPEZOID TIBIAL TRAY SZ 4F/4T
• 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: 21778138
• Report Number: 1038671-2025-01740
• Device Sequence Number: 20991572
• Product Code: JWH
• UDI-Device Identifier: 10885862047694
• UDI-Public: 10885862047694
• 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: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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: 01/28/2017
• Device Catalogue Number: 204-04-44
• 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: 07/12/2023
• Initial Report FDA Received Date: 04/04/2025
• Date Device Manufactured: 01/31/2012
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG