MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-22-09
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the revision reported was likely the result of wear and fracture of the tibial insert and femoral loosening after 13 years of implantation.However, the reported femoral loosening could not be confirmed from the provided information.Loosening may have led to an increase in cement and bone particles in the joint space or abnormal contact between the femoral component and tibial insert and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis and subsequent loosening.However, the contributions of loosening, prosthesis wear, and potential patient-related considerations to the sequence of events cannot be determined.Fracture of the tibial insert was confirmed, but the root cause of the fracture could not be determined from the available information.Potential contributions of user-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs were not provided.
Event or Problem Description
As reported, approximately 13 years post the initial total knee arthroplasty, the patient was revised due to an intercondylar fracture with tibial osteolysis, and loosening of the femoral component.Polyethylene asymmetry was observed.The patient was revised to competitor products.There was no reported breakage of a device or surgical delay/prolongation.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM
• 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 ; 3523771140
• MDR Report Key: 22493146
• Report Number: 1038671-2025-02488
• Device Sequence Number: 4096681
• Product Code: JWH
• UDI-Device Identifier: 10885862063953
• UDI-Public: 10885862063953
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 02/03/2018
• Device Catalogue Number: 244-22-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 02/04/2010
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG