MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-02-02
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544); Tissue Breakdown (2681); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 1311991 244-22-09 - optetrak hi-flex tibial insert, sz 2, 9mm.2863981 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t.2915165 200-02-29 - three peg patella 29mm.Multiple mdr reports were filed for this event, please see associated 1038671-2023-00553, 1038671-2024-04263, 1038671-2025-00287.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported via legal documentation that approximately 105 months after a left total knee replacement the patient underwent a revision surgery.The patient experienced pain and noises.A post operative report was provided.Post operative diagnosis noted polyethylene failure, metallosis and aseptic loosening.Intraoperatively the surgeon observed significant metallosis and necrotic tissue and synovitis.Although no signs of infection.The patellar component was noted to be significantly loose with metallosis and pockets of defect in the patella.The tibial tray component was removed, and the surgeon observed significant metallosis with necrotic tissue posteriorly, posterior medial and laterally as well as a large bony defect encompassing almost the whole lateral femoral condyle.No medical or surgical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, g, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and patellar loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images 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.

• Brand Name: OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, LEFT
• 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: 21171883
• Report Number: 1038671-2025-00288
• Device Sequence Number: 9468295
• Product Code: JWH
• UDI-Device Identifier: 10885862063779
• UDI-Public: 10885862063779
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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: 11/05/2018
• Device Catalogue Number: 244-02-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/07/2025
• Date Device Manufactured: 11/12/2013
• 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: 70 YR
• Patient Sex: Female