BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 50/44 J

    MDR report key: 1131888 · Received August 18, 2008

    Report

    Report Number
    9613350-2008-00101
    Event Type
    Injury
    Date Received
    August 18, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 17, 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

    INFO FORWARDED FROM THE OWNER ESTABLISHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR PERFORMED A PRIMARY TOTAL HIP ON PT. PT IN LATE 2006, AND REVISED CUP ONLY IN 2008 AT THE HOSPITAL. THE ACETABULUM AND CUP HAD SAME CHARACTERISTICS AS PREVIOUS ONES REPORTED. THERE WAS NO INFECTION AND NO METAL SENSITIVITY PRESENT. THE CUP WAS PULLED OUT WITH A RONGEUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 50/44 J DUROM ACETABULAR COMPONENT AND METASUL LDH LA KWA ZIMMER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R