BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE 132 SIZE 5.5

    MDR report key: 2920984 · Received January 17, 2013

    Report

    Report Number
    0002249697-2013-00087
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 1, 2009
    Report Date
    January 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE REPORTED DEVICE WAS NOT PROVIDED FOR EVALUATION. PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW BY A CONSULTING CLINICIAN WHO INDICATED THAT THE REPORTED PAIN COULD NOT BE CONFIRMED AND THERE WAS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THE COMPLAINTS DESCRIBED IN THE EVENT DESCRIPTION. A DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. THE EXACT ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED DUE TO MINIMAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING HIP AND GROIN PAIN SINCE 2009. RECENT BLOOD WORK RECORDS AN ELEVATED COBALT LEVEL OF 6.4. THE PATIENT'S PAIN IS CONSTANT AND ASSOCIATED WITH CERTAIN MOVEMENTS. PATIENT MUST USE A CANE OR WALKER TO WALK MORE THAN A FEW HUNDRED FEET. PATIENT SOMETIMES EXPERIENCES SHARP SHOOTING PAIN IN HIS HIP AND FEELS LIKE THE HIP SLIPS IN AND OUT OF JOINT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING HIP AND GROIN PAIN SINCE 2009. RECENT BLOOD WORK RECORDS AN ELEVATED COBALT LEVEL OF 6.4. THE PATIENT'S PAIN IS CONSTANT AND ASSOCIATED WITH CERTAIN MOVEMENTS. PATIENT MUST USE A CANE OR WALKER TO WALK MORE THAN A FEW HUNDRED FEET. PATIENT SOMETIMES EXPERIENCES SHARP SHOOTING PAIN IN HIS HIP AND FEELS LIKE THE HIP SLIPS IN AND OUT OF JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25977 ACCOLADE 132 SIZE 5.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 18812102S

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other