BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC HIP

    MDR report key: 1082455 · Received July 22, 2008

    Report

    Report Number
    2249697-2008-00215
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    March 17, 1999
    Report Date
    June 25, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PT'S HIP WAS SQUEAKING." FURTHER, PT ALLEGED THAT SHE SUFFERED A DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABC HIP IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other