BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 1329030 · Received March 3, 2009

    Report

    Report Number
    9613350-2009-00070
    Event Type
    Injury
    Date Received
    March 3, 2009
    Date of Event
    January 20, 2009
    Report Date
    January 27, 2009
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SURGICAL REVISION OF TOTAL HIP ARTHROPLASTY WITH REMOVAL OF A ZIMMER DUROM ACETABULAR COMPONENT. THE PHYSICIAN'S HISTORY AND PHYSICAL NOTE THAT THE PATIENT HAS HAD ONGOING PAIN ISSUES SINCE ORIGINAL ARTHROPLASTY PERFORMED IN 2007. PHYSICIAN NOTES IN THE MEDICAL RECORD AS POSTOPERATIVE DIAGNOSIS: PROBABLY MECHANICAL FAILURE OF ACETABULAR COMPONENTS, LESS LIKELY SENSITIVITY. PATIENT HAS REQUESTED DEVICE; THEREFORE, IT WILL NOT BE AVAILABLE FOR RETURN TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL LDH LA KWB ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R