BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE METAL COMPONENT

    MDR report key: 20762077 · Received November 22, 2024

    Report

    Report Number
    1038671-2024-04487
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    September 12, 2023
    Report Date
    November 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-01752 D10 CONCOMITANT DEVICES: 4119055 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5 4410204 200-02-38 - THREE PEG PATELLA 38MM 6163335 02-022-45-3545 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 4.5T MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-01752 THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, LOSS OF RANGE OF MOTION, AND 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 39 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, IMPLANT PAIN, DISCOMFORT, STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, COMPONENT LOOSENING, SWELLING/ EDEMA, OSTEOLYSIS, FAILURE OF IMPLANT, LOSS OF RANGE OF MOTION, AMBULATION OR POSTURAL DIFFICULTIES AND BALANCE PROBLEMS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798067 UNKNOWN KNEE METAL COMPONENT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H