BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLOCLASSIC SL STEM 5 12/14

    MDR report key: 2141557 · Received June 17, 2011

    Report

    Report Number
    9613350-2011-00402
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, (B)(4) , WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER GMBH CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT STATED THAT WHEN TRIES TO MOVE HIS RIGHT HIP HE GETS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOCLASSIC SL STEM 5 12/14 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL KWY ZIMMER GMBH 2342800

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other