BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 58/52 R

    MDR report key: 1060439 · Received June 13, 2008

    Report

    Report Number
    9613350-2008-00041
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    October 15, 2007
    Report Date
    May 14, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 DAYS POST OP THE ACETABULAR COMPONENT HAD LOOSENED, AND WAS REVISED 7 DAYS POST-OP. FEMORAL SIDE COMPONENTS WERE ALSO REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 58/52 R DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R