BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - STRYKER LEFT KNEE

    MDR report key: 2062740 · Received April 13, 2011

    Report

    Report Number
    2249697-2011-00461
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 18, 2001
    Report Date
    March 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT CALLED TO REPORT THAT HE HAD A KNEE IMPLANTED IN 1999, BUT THE SCREW CAME OUT OF IT. HE SAID THAT NOW HIS KNEE (THI IS HIS LEFT KNEE) IS TURNING OUT TO THE RIGHT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - STRYKER LEFT KNEE IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other