BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL TAPER LINER, HH/36

    MDR report key: 2831660 · Received November 9, 2012

    Report

    Report Number
    9613350-2012-01059
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED THE DEVICE. ONCE THE INVESTIGATION HAS BEEN DONE AND THE RESULTS BECOME AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) OLD FEMALE PT HAD A TOTAL HIP REPLACEMENT IN (B)(6) 2011. IN (B)(6) 2012, SHE COMPLAINED OF A "CLICKING SOUND WHEN SHE SEATS AND CROSSES HER LEGS" AND WHEN SHE HAS WALKED FOR A CERTAIN "PERIOD OF TIME". THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO LOOSENING OF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METASUL TAPER LINER, HH/36 METASUL TAPER LINERS, METASUL FEMORAL KWA ZIMMER GMBH 2555081

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R