BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 54/48 N

    MDR report key: 2931151 · Received January 22, 2013

    Report

    Report Number
    9613350-2013-01282
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2009
    Report Date
    January 4, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER 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. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT 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 EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. A TIGHT MONITORING IS ONGOING FOR REVISION WITH U.S. DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RE-LAUNCH OF THE U.S. DUROM CUP. THE NEED FOR FURTHER CORRECTIVE MEASURES 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

    IT HAS BEEN REPORTED THAT THE PT RECEIVED A DUROM U.S. ACETABULAR COMPONENT 54/48 N ON THE LEFT SIDE ON (B)(6) 2008 AND IS BEING MONITORED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29529 DUROM US ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2433606

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other