BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 54/48 N

    MDR report key: 1222041 · Received November 3, 2008

    Report

    Report Number
    9613350-2008-00202
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 DR PERFORMED A PRIMARY TOTAL HIP ON PT IN 2007. THE CUP ONLY WAS REVISED IN 2008. THE CUP WAS LOOSE, HAD NO INGROWTH AND THERE WAS A YELLOWISH FLUID BETWEEN THE CUP AND ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 54/48 N DUROM US ACETABULAR COMPONENT AND METASUL LDH LA KWA ZIMMER GMBH 2349659

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R