BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 56/50 P

    MDR report key: 1153247 · Received September 5, 2008

    Report

    Report Number
    9613350-2008-00093
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 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
    MD, 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 THE ACETABULAR COMPONENT WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 56/50 P DUROM ACETABULAR COMPONENT AND METASUL LDH LA KWA ZIMMER GMBH 2330094

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R