BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SUMMIT STEM #5

    MDR report key: 3200456 · Received July 1, 2013

    Report

    Report Number
    1818910-2013-20270
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE DISREGARD MFR REPORT NUMBER 1818910-2013-20270, AS IT WAS CREATED IN ERROR.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, DISCOMFORT, MALAISE, SWELLING, IMMOBILIZATION AND TISSUE DAMAGE AFTER ASR HIP IMPLANT. UPDATE: (B)(6) 2012 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2013-SALES REP REPORTED REVISION SURGERY DUE TO PATIENT'S REQUEST. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOR: (B)(6) 2013. UPDATE: (B)(6) 2013 - MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO METALLOSIS. ADDITIONALLY, THE REVISION REPORT INDICATES THAT IN EXAMINING THE CALCAR, THERE WERE A FEW AREAS THAT WERE SUSPECT FOR A POSSIBLE NONDISPLACED FRACTURE. THE NEWLY IMPLANTED STEM HAS BEEN ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298866 UNKNOWN DEPUY SUMMIT STEM #5 FEMORAL STEM KWY DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention