BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT

    MDR report key: 2931141 · Received January 22, 2013

    Report

    Report Number
    9613350-2013-01288
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT WAS NOT REOPERATED TO DATE. WHERE LOT NUMBER WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AS NO LOT NUMBERS 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 INFO PROVIDED. A PRODUCT FAILURE CANNOT BE MONITORED. 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 REVISIONS WITH U.S. DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RELAUNCH 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. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT RECEIVED AN ACETABULAR CUP ON (B)(6) 2010 IN HER RIGHT HIP. ON (B)(6) 2011 DUE TO PAIN AND SIGN OF LOOSENING, A REVISION SURGERY WAS RECOMMENDED TO THE PT. THE REVISION SURGERY WAS NOT PERFORMED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29459 DUROM US ACETABULAR COMPONENT DUROM US ACETABULAR COMPONENT 54/48 N KWA ZIMMER GMBH 2392898

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention