BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - CUP

    MDR report key: 2132578 · Received June 10, 2011

    Report

    Report Number
    2249697-2011-00860
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2010
    Report Date
    May 26, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # UNK, LOT # UNK, DESCRIPTION: ACCOLADE RIGHT HIP REPLACEMENT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "FROM DAY 1 THIS PATIENT HAS BEEN EXPERIENCING PAIN. A BONE SCAN WAS DONE AND IT SHOWS A LOOSE CUP. HE HAS BACK AND KNEE PAIN. RIGHT LEG IS LONGER THAN THE LEFT LEG. HE HAS BEEN DOING RESEARCH AND WOULD LIKE TO KNOW IF ANY OF HIS IMPLANTS HAVE BEEN RECALLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - CUP IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R