BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION 8" HA HIP STEM

    MDR report key: 1062182 · Received June 13, 2008

    Report

    Report Number
    2249697-2008-00170
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 22, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    K944836
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE TEMPLATING SHOWED THAT IT WAS THE STEM WITH THE ITEM NUMBER THAT WOULD FIT. THE TRIAL STEM MATCHED THIS SIZE, BUT WHEN THE SURGEON SHOULD IMPLANT THE STEM IT WENT DOWN (IT SANKED)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION 8" HA HIP STEM IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other