BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 52/46 L

    MDR report key: 1276968 · Received December 22, 2008

    Report

    Report Number
    9613350-2008-00307
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEM STEM IMPLANTED APPROXIMATELY TWO YEARS AGO. THE PATIENT HAD HIP PAIN SINCE THE TIME OF IMPLANTATION. DR DETERMINED THAT THE ACETABULAR SHELL WAS THE PROBLEM. THERE WAS NO EVIDENCE OF BONE INGROWTH OR ONGROWTH ON THE DUROM SHELL. DR REIMPLANTED A TRILOGY SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL LDH LA KWB ZIMMER GMBH 2367247

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R