BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINTERTHUR HIPS

    MDR report key: 3142489 · Received April 22, 2013

    Report

    Report Number
    9613350-2013-01535
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 5, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE IMPLANT WAS IN SITU DURING 20 YEARS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    EVENT TIMING: AFTER SURGERY. IT IS REPORTED THAT THE PT RECEIVED A HIP IMPLANT (ASSUMED A CLS CUP) ON (B)(6) 1993 IN HER LEFT HIP. SHE WAS REVISED ON (B)(6) 2013 DUE TO BREAKAGE, DISLOCATION, OSTEOLYSIS, PAIN AND LARGE BONE DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173305 WINTERTHUR HIPS NONE KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization