BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5 CANCELLOUS BONE SCREW 25MM

    MDR report key: 2885007 · Received December 12, 2012

    Report

    Report Number
    2249697-2012-02625
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    September 1, 2009
    Report Date
    November 19, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWC
    PMA / PMN Number
    K894124
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 6.5 CANCELLOUS BONE SCREW 25MM, CAT # 2030-6525-1, LOT # MHATRH, MANUFACTURED FEBRUARY 2, 2009 WAS ALSO LISTED IN THIS REPORT. AT THIS TIME, IT REMAINS UNKNOWN WHICH SCREW WAS FOUND TO BE SHEARED OFF. ADDITIONALLY, IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: THE PATIENT BEGAN EXPERIENCING SHARP PAIN IN THE BACK OF HER RIGHT HIP IN (B)(6) 2010. THE PAIN BECAME EXTREME OVER TIME. THE PATIENT EVENTUALLY BEGAN USING A WHEEL CHAIR BECAUSE THE HIP AND LEG FELT UNSTABLE LIKE IT WAS GOING TO GIVE WAY. THE PATIENT HAD X-RAYS THAT REVEALED A SCREW IN THE IMPLANT HAD SHEARED OFF. THE PATIENT HAD A TOTAL REVISION SURGERY IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5 CANCELLOUS BONE SCREW 25MM IMPLANT HWC STRYKER ORTHOPAEDICS MAHWAH NA MHDA38

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention