BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 58/52 R

    MDR report key: 1253396 · Received December 2, 2008

    Report

    Report Number
    9613350-2008-00245
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC. (ESTABLISHMENT 1822565), WHICH MARKETS THE DEVICES IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DUROM SHELL WAS REVISED DUE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 58/52 R DUROM ACETABULAR COMPONENT AND METASUL LDH LA KWB ZIMMER GMBH 2392123

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R