BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 54/48 N

    MDR report key: 1201815 · Received October 15, 2008

    Report

    Report Number
    9613350-2008-00179
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DUROM CUP WAS REMOVED ON PATIENT AND REPLACED WITH A CONVERGE CUP. THE CUP WAS LOOSE AND CAUSING PAIN. THE PATIENT STARTING HAVING PAIN LESS THAN 3 MONTHS AGO. SHE EVEN HAD HER OTHER SIDE DONE WITH A DUROM HIP AFTER THE FIRST TONE. THE CUP WAS DOING FINE INITIALLY AND THE LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL LDH LA KWA ZIMMER GMBH 2361513

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R