BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EIUS UNI KNEE XS FEM RM/LL

    MDR report key: 2503691 · Received March 21, 2012

    Report

    Report Number
    9610726-2012-00086
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    April 17, 2009
    Report Date
    March 5, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSX
    PMA / PMN Number
    K992287
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. DEVICES WERE DISCARDED. ADDITIONAL INFORMATION (X-RAYS, MEDICAL RECORDS, OPERATIVE NOTES) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT NUMBER 6636-2-316, LOT NUMBER 1YMHL DESCRIPTION: EIUS UNI TIB XS 6MM RM/LL. CAT NUMBER 6197-9-001, LOT NUMBER MBP01 DESCRIPTION: SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT'S RIGHT KNEE LOCKED UP AND SHE COULDN'T MOVE IT SO THE SURGEON REVISED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIUS UNI KNEE XS FEM RM/LL IMPLANT HSX STRYKER ORTHOPAEDICS LIMERICK NA SBJ3C

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention