BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 1227549 · Received November 13, 2008

    Report

    Report Number
    9613350-2008-00205
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 PRODUCT SURVEILLANCE RECEIVED A VOICEMAIL FROM A GENTLEMAN, WHOSE DAUGHTER HAD A DUROM CUP IMPLANTED IN 2006 AT HEALTH SERVICES CENTER. HE SAID THAT SHE HAS HAD LOTS OF PAIN SINCE THE SURGERY, AND HER DOCTOR WHO IS GOING TO REVISE HER JUST INFORMED HER THAT THE DUROM CUP WAS "RECALLED".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R