BEUDAMED
    FDA Adverse Event Summary report: N

    SYNTHES USA PLATE RIGHT FEMUR

    MDR report key: 3062774 · Received April 11, 2013

    Report

    Report Number
    MW5029765
    Date Received
    April 11, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT HAD HIP SURGERY ON (B)(6) 2012 WITH A SYNTHES USA PLATE USED. PT HAD PAIN IN HIP AREA FROM PREVIOUS SURGERY AROUND 3 WEEKS PRIOR TO COMING INTO THE HOSPITAL ON (B)(6) 2013. BASED ON X-RAY, APPEARED PLATE WAS FRACTURED. PT DID NOT RECALL DOING ANY ACTIVITY THAT WOULD HAVE CAUSED THE PLATE TO FRACTURE. HIP SURGERY WAS PERFORMED ON (B)(6) 2013 AND THE DX WAS NONUNION PERIPROSTHETIC FRACTURE, RIGHT FEMUR AROUND THE BIPOLAR STEM WITH DEGENERATIVE ARTHRITIS ACETABULUM. THE PROCEDURE PERFORMED WAS REMOVAL OF BIPOLAR PROSTHESIS RIGHT HIP, REVISION RIGHT TOTAL HIP ARTHROPLASTY AND OPEN REDUCTION INTERNAL FIXATION RIGHT FEMUR FRACTURES. DURING SURGERY PT EXPERIENCED 1000CC BLOOD LOSS, REC'D 6 UNITS OF PACKED RED BLOOD CELLS, AND WAS TEMPORARILY INTUBATED AND TRANSFERRED TO ICU. SHE RECOVERED WELL DURING HOSPITALIZATION AND WAS DISCHARGED TO NURSING HOME IN STABLE CONDITION ON (B)(6) 2013 FOR REHABILITATION SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156161 SYNTHES USA PLATE RIGHT FEMUR PLATE NAR LCP HRS SYNTHES USA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization