BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER FEMORAL IMPLANT

    MDR report key: 2961495 · Received February 10, 2013

    Report

    Report Number
    2961495
    Event Type
    Malfunction
    Date Received
    February 10, 2013
    Date of Event
    January 3, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STRYKER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SUSPECTED HARDWARE FAILURE- PATIENT HAD A TOTAL KNEE ARTHROPLASTY PERFORMED AT AN OUTSIDE INSTITUTION. HE WAS UNABLE TO ACHIEVE THE TYPE OF RESULT HE WOULD LIKE WITH A FEELING OF LOCKING AND GIVING WAY OF HIS KNEE JOINT. IN ADDITION, HE HAD PAIN AND CREPITUS OVER THE LATERAL SIDE OF THE JOINT. HIS COMPONENTS APPEARED TO BE WELL FIXED AND THERE WAS NO EVIDENCE OF INFECTION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REVISION RIGHT TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57873 STRYKER FEMORAL IMPLANT PROSTHESIS, IMPLANT JWH STRYKER UNK UNK
    57874 STRYKER TIBIAL PLATE PLATE, FIXATION, BONE HRS STRYKER UNK UNK
    57875 STRYKER POLY INSERT PROSTHESIS, KNEE, HEMI-, TIBIAL JWH STRYKER UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR