BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMW 3 BONE CEMENT 40 G

    MDR report key: 9569702 · Received January 8, 2020

    Report

    Report Number
    MW5092131
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    March 12, 2010
    Report Date
    January 7, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010 DR. (B)(6) PLACED A DEPUY SIGMA P.F.C. HIGH FLEX KNEE IN MY BODY. I HAD PROBLEMS WITH THE IMPLANT FROM THE 3RD MONTH. DR. (B)(6) DIDN'T THINK IT WAS LOOSENING. CONTINUING TO SEE (B)(6), THE LEG CONTINUED TO GET BETTER BECAUSE THE JOINT WAS REPLACED BUT VERY SWOLLEN. AT ONE YEAR THERE WAS STILL LUCENCY AT THE JOINT. (B)(6) STILL INSISTING IT WASN¿T THE KNEE SO I MOVED ON WITH MY LIFE. LOST JOB, LOST HOUSE, PERMANENTLY DISABLED FROM FAULTY KNEE REPLACEMENT NOT BACK ISSUE. FAST FORWARD TO 2018 STILL HAVING RIGHT LEG PAIN, SWELLING AND DISABILITY; MY DOCTOR SUGGESTED A REVISION OF MY KNEE. POINT OF DISCOVERY (B)(6) 2018. DR. (B)(6) REPLACED MY FAILED KNEE, HE STATES TO MY WIFE ¿HE JUST LIFTED THE IMPLANT OUT¿. NOT THINKING ANYTHING OF IT I WENT ON WITH MY LIFE. ON (B)(6) I SAW A COMMERCIAL FOR CEMENT FAILURE LAWSUIT AND AT THAT POINT ALL LIGHTS TURNED ON AND I REALIZED I WAS HURT BY THE FIRST KNEE REPLACEMENT AND IT WAS DEPUY WHO IS AT FAULT. STICKER SHEET READS AS FOLLOWS: CMW3 BONE CEMENT. QTY 3 LOT 2922894, CMW3 BONE CEMENT. QTY 1; LOT 2946642, REF 96-0113. END MY CLAIM DEPUY 3 BONE CEMENT IS HARMFUL TO CONSUMERS. POTENTIALLY DEADLY! THIS SURGERY WAS THE POINT OF DISCOVERY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29863 CMW 3 BONE CEMENT 40 G CMW 3 BONE CEMENT 40 G LOD DEPUY ORTHOPAEDICS 3332040 2922894
    29864 CMW 3 BONE CEMENT 40 G CMW 3 BONE CEMENT 40 G LOD DEPUY ORTHOPAEDICS 3332040 2922894
    29865 CMW 3 BONE CEMENT 40 G CMW 3 BONE CEMENT 40 G LOD DEPUY ORTHOPAEDICS 3332040 2922894
    29866 CMW 3 BONE CEMENT 40 G CMW 3 BONE CEMENT 40 G LOD DEPUY ORTHOPAEDICS 3332040 2946642

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| O| R| S