BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL COMPONENT

    MDR report key: 2171333 · Received July 15, 2011

    Report

    Report Number
    2249697-2011-01062
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE INVESTIGATION IS COMPLETED THE RESULTS WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    "IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION. IT WAS REPORTED THE UNIT HAD BEEN ORIGINALLY IMPLANTED 15 YEARS AGO. IT WAS REPORTED THAT X-RAYS REVEALED THAT THE UNIT WAS LOOSE IN (B)(6) 2011. IT WAS REPORTED THAT DURING SURGERY IT WAS DISCOVERED THAT THE UNIT HAD FRACTURED. IT WAS REPORTED THAT THE BONE SURROUNDING THE IMPLANT HAS DISINTEGRATED AND LONGER SUPPORTED THE IMPLANT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R