BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM STYLE FEMORAL SLEEVE

    MDR report key: 6212410 · Received December 27, 2016

    Report

    Report Number
    MW5066964
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    July 6, 2016
    Report Date
    December 8, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    LWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE WAITING TO BOARD A BUS IN (B)(6), I GOT UP TO WALK AND A SCREW ATTACHING MY FEMORAL STEM TO THE KNEE JOINT BROKE. THE LEFT KNEE PROSTHESIS WAS PUT IN ON (B)(6) 2009. INDICATIONS FOR PROCEDURE: MR. (B)(6) IS A(B)(6) GENTLEMAN WHO FIRST HAD A FEMUR FRACTURE, WHICH HEALED WITH 100 PERCENT DISPLACEMENT AND SHORTENING. THE PATIENT SUBSEQUENTLY UNDERWENT TOTAL KNEE ARTHROPLASTY, WHICH WAS UNSTABLE AND THEN AGAIN REVISION TO A HANGER PROSTHESIS. THERE MAY HAVE BEEN MORE THAN ONE STOPPING INVOLVED, AS THERE WAS AT LEAST A LINER EXCHANGE AT ONE POINT. THE PATIENT PRESENTS AT THIS TIME WITH A PAINFUL AND RADIOGRAPHICALLY LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856213 S-ROM STYLE FEMORAL SLEEVE S-ROM STYLE FEMORAL SLEEVE LWJ DEPUY ORTHOPAEDICS CD2BY4000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R