BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2921646 · Received January 15, 2013

    Report

    Report Number
    9613350-2013-01246
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    October 26, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBER WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICES RETURNED FOR EVALUATIONS, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH US DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RE-LAUNCH OF THE US 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

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE ALLEGED USE OF THE DUROM ACETABULAR COMPONENT. IT IS UNKNOWN AT THIS TIME IF THE HIP PRODUCT IS ACTUALLY THE DUROM CUP. THE PT RECEIVED THE IMPLANT ON (B)(6) 2009 AND UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO KNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22928 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND "METASUL" KWA ZIMMER GMBH 2357510

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Hospitalization| R