MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	232-03-03
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 21-0901-00t-l1 - stryker s6 90x13/21x1.0, (b)(6), 200-04-33 - (disc) cemented finned t ib.Tra sz 3f/3t, (b)(6), 200-23-09 - cr tibial insert sz3, 9mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported a 52 yo male patient who had a right knee implanted, underwent a revision procedure approximately 10 years and 10 months post the initial procedure.The patient was revised due to premature polyethylene wear with massive osteolysis.Associated with a pseudotumoral lesion in the popliteal area secondary to a foreign body reaction caused by polyethylene particles.The patient was revised to a competitor¿s devices.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted devices are not available for return.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3 - the revision reported was likely caused by tibial insert prosthesis wear over the course of 10 years, which led to metal component wear of the femoral and/or tibial tray.The extent of the wear and possible causes could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.H6 the following sections were corrected: h6 - codes 4756, 4118, 3233, 11 no longer applies should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: OPTETRAK
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22319933
• Report Number: 1038671-2025-02364
• Device Sequence Number: 21040399
• Product Code: JWH
• UDI-Device Identifier: 10885862063106
• UDI-Public: 10885862063106
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 08/22/2019
• Device Catalogue Number: 232-03-03
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2014
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 52 YR
• Patient Sex: Male