BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP

    MDR report key: 2950442 · Received February 6, 2013

    Report

    Report Number
    9613350-2013-01327
    Event Type
    Other
    Date Received
    February 6, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 20, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR 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 EVENTS CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. A TIGHT MONITORING IS ONGOING FOR REVISION WITH THE U.S. DUROM CUPS WERE THE INITIAL IMPLANT DATA OCCURRED AFTER THE RE-LAUNCH OF THE U.S. DUROM CUP. THE NEED FOR FURTHER CORRECTIVE MEASURE IS NOT INDICATED AT THIS TIME. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED MEANWHILE DUE TO BUSINESS REASONS. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED OUT OF THE USE OF A DUROM HIGH. IT WS REPORTED THAT THE PT RECEIVED A DUROM HIP GENERIC ON THE LEFT SIDE ON (B)(6) 2009 AND IS BEING MONITORED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50260 DUROM HIP DUROM HIP LZO ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other