BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCLASSIC

    MDR report key: 2243775 · Received August 30, 2011

    Report

    Report Number
    9613350-2011-00567
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    April 23, 2010
    Report Date
    August 22, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBER WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE DETERMINED FROM THE INFO PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT IMPLICATE A PRODUCT FAILURE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT TOTAL HIP ARTHROPLASTY WITH DATE UNK. REVISION STATUS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOCLASSIC ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL LZO ZIMMER, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other