BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SYSTEM RIM FLARE POROUS SHELL WITH SPIKES

    MDR report key: 1200656 · Received October 17, 2008

    Report

    Report Number
    1822565-2008-00708
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    June 10, 2002
    Report Date
    September 19, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    Z-406-1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE PT THAT SHE UNDERWENT LEFT TOTAL HIP REPLACEMENT IN 2000 WITH A SULZER ORTHOPEDICS COVERAGE SHELL THAT WAS LATER RECALLED AND PT WAS REVISED IN 2002 FOR PAIN COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTER-OP ACETABULAR SYSTEM RIM FLARE POROUS SHELL WITH SPIKES HIP PROSTHESIS KWB ZIMMER, INC. NA 1418655

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R