BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL BASEPLATE M-2?

    MDR report key: 1844706 · Received September 20, 2010

    Report

    Report Number
    9610726-2010-00331
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 9, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K920034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SUBJECT HAD DEGENERATIVE JOINT DISEASE REQUIRING BILATERAL TOTAL KNEE REPLACEMENT. REVISION SURGERY WAS CONDUCTED ON RIGHT KNEE DUE TO A LOOSE TIBIAL COMPONENT AND A SUBSIDED VARUS POSITION OF THAT PRIMARY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL BASEPLATE M-2? UNK JWH STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention