BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 56/50 P

    MDR report key: 1233864 · Received November 13, 2008

    Report

    Report Number
    9613350-2008-00211
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    July 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 PATIENT UNDERWENT TOTAL HIP REPLACEMENT IN 2008, IN WHICH HE RECEIVED A DUROM CUP ACETABULAR COMPONENT. POST-OP, PATIENT EXPERIENCED PAIN AND UNDERWENT REVISION SURGERY. ABOUT SIX MONTHS LATER, LACK OF BONY INGROWTH WAS NOTED.

    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 2395160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R