BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCLASSIC SL STEM 2 12/14

    MDR report key: 2270054 · Received September 20, 2011

    Report

    Report Number
    9613350-2011-00611
    Event Type
    Injury
    Date Received
    September 20, 2011
    Date of Event
    September 29, 2009
    Report Date
    August 22, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SHOULD ADD'L 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 AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT STATED THAT RIGHT HIP REVISION WAS DONE DUE TO ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOCLASSIC SL STEM 2 12/14 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL KWY ZIMMER, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R