BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR SHORT NECK

    MDR report key: 2840502 · Received November 7, 2012

    Report

    Report Number
    9616680-2012-00998
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    July 20, 2012
    Report Date
    October 9, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY/STERILIZATION RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. MEDICAL REVIEW INDICATED THAT ALTHOUGH THE PT MAY HAVE HAD AN ADVERSE RESPONSE TO METAL WEAR DEBRIS, THE PRIMARY ISSUE WAS PROBABLY AN INFECTION. THE REPORTED INFECTION WAS NOT CONFIRMED AND THE SOURCE OF THE INFECTION COULD NOT BE IDENTIFIED. THE CLINICAL PRESENTATION AND SYMPTOMS FOR REACTIONS TO METAL DEBRIS CAN BE SIMILAR TO OTHER COMPLICATIONS SUCH AS INFECTION. W/O FURTHER INFO AND THE PHYSICAL DEVICES THE INFECTION AND/OR ADVERSE RESPONSE TO METAL WEAR DEBRIS CANNOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED BY THE PT THAT APPROX SIX MONTHS AFTER THE PT HAD A THR SHE STARTED EXPERIENCING SYSTEMIC SYMPTOMS, THERE WAS FLUID ON THE MUSCLE THAT WAS ASPIRATED AND THE FLUID WAS INFECTED. PT DEVELOPED CHRONIC COUGH AND FATIGUE. PT NOW CAN'T LIFT LEG OFF THE FLOOR - LOSS OF MUSCLE, SLOWLY GETTING WORSE. SURGEON WANTS TO REVISE BUT PT FEELS LIKE SHE NEEDS TO FIND OUT MORE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII MODULAR SHORT NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G3053238

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R