BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY REPLICAPINNACLE MARATHON ACETABULAR LINER - LIPPED LIP LNR ANG 48 MM OD 28

    MDR report key: 2760190 · Received June 11, 2007

    Report

    Report Number
    2760190
    Event Type
    Injury
    Date Received
    June 11, 2007
    Date of Event
    April 4, 2007
    Report Date
    May 25, 2007
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD RECEIVED INITIAL HIP IMPLANT AT (B)(6) HOSPITAL IN (B)(6) 2006. SHE WAS SEEN IN (B)(6) 2006 DUE TO THIS IMPLANT APPARENTLY NOT FUNCTIONING PROPERLY. SHE HAD SURGERY ON (B)(6) 2007 TO REMOVE THE DEVICE AND HAVE A NEW DEVICE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY REPLICAPINNACLE MARATHON ACETABULAR LINER - LIPPED LIP LNR ANG 48 MM OD 28 HIP REPLACEMENT DEVICE KWA AJ8BN1000
    2 DEPUY REPLICA ARTICUL/EZE FEMORAL HEAD 28MM +5 12/14 CONE HIP REPLACEMENT DEVICE KXA 2117200

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R