MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY, HI-FLEX PS CEM FEM, SZ 4, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-03-04
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Granuloma (1876); Osteolysis (2377)
Date of Event	09/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 200-02-32 - three peg patella 32mm.204-04-43 - trapezoid tibial tray sz 4f/3t.244-24-11 - optetrak hi-flex tibial insert sz 4 11mm.The revision reported was likely the result of polyethylene wear of the tibial insert and an insufficient bond between the femoral component and bone, which led to aseptic (non-infected) femoral loosening and osteolysis.Contributing factors to the severe wear may have been the result of gross instability and being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the devices were not returned for evaluation 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.
Event or Problem Description
As reported, approximately five years post initial right tka, the 62 y/o male had a premature polyethylene wear and delamination of insert resulting in granuloma and massive osteolysis with loosening of femoral components and significant bone defects medial and lateral femoral condyles.Patient revised to competitor's components with sleeves and stem extensions and allograft bone grafting to femur.There was no breakage of device or surgical delay/prolongation.Image received.The devices will not be returned for evaluation as it was discarded by hospital.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 type of investigation, investigation findings, and investigation conclusions.
Additional Manufacturer Narrative
The revision reported was likely the result of polyethylene wear of the tibial insert and an insufficient bond between the femoral component and bone, which led to aseptic (non-infected) femoral loosening and osteolysis.Contributing factors to the severe wear may have been the result of gross instability and being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.

• Brand Name: OPTETRAK ASY, HI-FLEX PS CEM FEM, SZ 4, RIGHT
• 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: 21773688
• Report Number: 1038671-2025-01736
• Device Sequence Number: 20898849
• Product Code: JWH
• UDI-Device Identifier: 10885862063854
• UDI-Public: 10885862063854
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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,Followup,Followup
• Report Date (Section B): 04/07/2025

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: 04/18/2022
• Device Catalogue Number: 244-03-04
• 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: 05/28/2023
• Supplement Date Received by Manufacturer: 04/03/2025; 04/03/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/07/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 89 KG