BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2439155 · Received January 31, 2012

    Report

    Report Number
    2249697-2012-00121
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED NI THIS REPORT: CAT # NLS-300000B, LOT# 34563702, DESCRIPTION: LRG TAP PRI MOD NCK 0DEG 30MM. 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, "THE PATIENT COMPLAINED OF PAIN. MASSIVE METALLOSIS AND DESTRUCTION OF SOFT TISSUE BED WAS DISCOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA MJN1JJ

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R