BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - PCA HEAD

    MDR report key: 1678162 · Received May 6, 2010

    Report

    Report Number
    2249697-2010-00499
    Event Type
    Injury
    Date Received
    May 6, 2010
    Date of Event
    April 14, 2010
    Report Date
    April 14, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALSO UNKNOWN PCA STEM WAS REPORTED. THE REASON FOR REVISION WAS NOT PROVIDED. SUMMARY OF EVAL: THE ROOT CAUSE OF THE FEMORAL FRACTURE AND THE PCA HEAD BEING LOCKED ON THE STEM COULD NOT BE DETERMINED, AS INSUFFICIENT INFO WAS PROVIDED. THE LOT CODE AND CATALOG NUMBERS FOR THE REPORTED DEVICES WAS NOT PROVIDED. THE X-RAYS AND MEDICAL RECORDS WERE REQUESTED, BUT NOT PROVIDED. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING THE REVISION SURGERY, THE SURGEON COULD NOT REMOVE THE PCA HEAD FROM PCA STEM. BECAUSE IT WAS LOCKED TOO TIGHTLY. AS A RESULT, WHEN THE SURGEON WAS TRYING TO REMOVE THE PCA HEAD FROM THE PCA STEM, THE PT'S FEMUR WAS FRACTURED. THE SURGERY WAS COMPLETE TO USE NON STRYKER BRAND (JMM)."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention