BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK KNEE COMPONENTS

    MDR report key: 21828314 · Received April 11, 2025

    Report

    Report Number
    1038671-2025-01796
    Event Type
    Injury
    Date Received
    April 11, 2025
    Report Date
    April 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. D10: 200-03-32 - ONE PEG PATELLA 32MM: 2059831, 200-04-21 - CEMENTED FINNED TIB. TRA SZ 2F/1T: 1201540, 200-21-09 - CR TIBIAL INSERT SZ 1, 9MM: 1060171, 230-03-01 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 1,: 1822659.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT STATED THEY UNDERWENT LEFT KNEE REPLACEMENT SURGERY APPROXIMATELY 14 YEARS AGO AND IS CURRENTLY SUFFERING FROM SEVERE PAIN. THEY NOTED THAT THEIR DOCTOR HAS INDICATED THAT NEITHER REPAIR NOR REMOVAL OF THE KNEE REPLACEMENT IS POSSIBLE. ADDITIONALLY, THE PATIENT MENTIONED THAT STEROID INJECTIONS ARE NOT AN OPTION DUE TO THE PLASTIC OF THE KNEE REPLACEMENT, LEAVING THEM WITHOUT ANY RELIEF SOLUTIONS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989111 OPTETRAK KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11