BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEPUY CMW 2 40G

    MDR report key: 2903889 · Received January 9, 2013

    Report

    Report Number
    1818910-2013-10636
    Event Type
    Death
    Date Received
    January 9, 2013
    Report Date
    January 24, 2013
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    PK053003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DURING A HIP REPLACEMENT (NECK FEMUR) THE PATIENT SADLY SUFFERED A HEART ATTACK DURING THE CEMENT INSERTION AND DIED OF GENERAL HEART FAILURE 3 HOURS LATER IN POST OP CARE. FOLLOWING THE PATIENT DEATH NO TRACE OF REACTION WAS FOUND IN BLOOD SAMPLES AND NO EMBOLISM WAS FOUND. THEREFORE TRUE CAUSE OF CARDIAC ARREST IS UNCONFIRMED. THERE ARE KNOWN RISKS, ASSOCIATED WITH THE USE OF BONE CEMENT, INCLUDING CARDIAC ARREST AND A HIGHER MORTALITY RATE ASSOCIATED WITH FEMORAL NECK FRACTURE; THESE RISKS ARE HIGHLIGHTED IN THE IFU AS FOLLOWS: SERIOUS ADVERSE EVENTS, SOME WITH FATAL OUTCOME, ASSOCIATED WITH THE USE OF BONE CEMENTS INCLUDE: MYOCARDIAL INFARCTION, CARDIAC ARREST, CEREBROVASCULAR ACCIDENT, PULMONARY EMBOLISM, ANAPHYLAXIS. THE EXPULSION OF BONE MARROW HAS BEEN ASSOCIATED WITH THE OCCURRENCE OF PULMONARY EMBOLISMS, AND THIS RISK HAS BEEN FOUND TO BE INCREASED IN PATIENTS WITH HIGHLY OSTEOPOROTIC BONE AND PATIENTS DIAGNOSED WITH FEMORAL NECK FRACTURE. "..IN PATIENTS DIAGNOSED WITH FEMORAL NECK FRACTURE, AS SOME PUBLISHED LITERATURE HAS INDICATED THERE IS A POTENTIAL FOR INCREASED MORTALITY..." CMW 2 IS A FAST SETTING CEMENT. THIS CEMENT IS OFTEN USED TO CEMENT THE ACETABULUM DURING TOTAL HIP REPLACEMENT SURGERY, BUT IT IS STATED IN THE IFU THAT, IT IS GENERALLY NOT SUITABLE FOR FIXATION OF THE FEMORAL COMPONENTS OF HIP REPLACEMENTS. THIS IS DUE TO THE FACT THAT ALTHOUGH THE ACETABULUM CAN BE CEMENTED RELATIVELY QUICKLY, IT CAN TAKE MORE TIME TO CEMENT THE FEMUR AND THEREFORE, THE SURGEON MAY RUN OUT OF CEMENT WORKING TIME, THE RISK BEING THAT THE CMW 2 CEMENT MAY SET (OR HARDEN) BEFORE THE IMPLANT HAS BEEN FULLY INSERTED INTO THE BONE. IT MUST BE STRESSED THAT THE USE OF THE CMW 2 CEMENT IN THE FEMUR IS NOT CONTRAINDICATED AND IN ADDITION IT MUST BE STRESSED THAT THE USE OF THE CMW 2 CEMENT FOR FEMORAL NECK FRACTURE IS NOT CONTRAINDICATED. THE ABOVE STATEMENTS ARE WARNINGS IN THE IFU, TO CONSIDER POTENTIAL RISKS ASSOCIATED WITH THE USE OF ANY BONE CEMENT (NOT NECESSARILY CMW 2) FOR FEMORAL NECK FRACTURE. INDEED MANY SURGEONS HAVE USED BONE CEMENT FOR FEMORAL NECK FRACTURE WITHOUT ANY ADVERSE INCIDENCE. THE SURGEON TAKES THE INTERESTS OF THE PATIENT INTO ACCOUNT BALANCING THE RISKS WITH THE BENEFITS OF THE SURGERY. THROUGH THEIR TRAINING, SURGEONS WILL BE FAMILIAR WITH THE CEMENT THEY ARE USING AND UNDERSTAND HOW THE CEMENT HANDLES IN TERMS OF CEMENT WORKING TIME AND SETTING TIME. THESE TIMINGS CAN BE AFFECTED BY ENVIRONMENTAL CONDITIONS, SUCH AS STORAGE AND OR TEMPERATURES, AND AS AN AID, TIMINGS CHARTS ARE INCLUDED TOWARDS THE BACK OF THE IFU AS A REFERENCE. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    UPDATED INFORMATION RECEIVED.

    Description of Event or Problem · 1

    MY MOTHER DIED DURING A HIP REPLACEMENT (NECK FEMUR) 2 YEARS AGO WHERE THE CAUSE OF DEATH IS RELATIVELY UNKNOWN NOW, EVEN AFTER THE INQUEST WHICH RETURNED A NARRATIVE VERDICT. SHE SUFFERED A HEART ATTACK DURING THE CEMENT INSERTION AND DIED OF GENERAL HEART FAILURE 3 HOURS LATER IN POST OP CARE. I ALREADY KNOW OF BONE CEMENT IMPLANTATION SYNDROME WHICH GIVES SOME LIGHT AS TO THE CAUSE OF THESE RARE AND SUDDEN REACTIONS BUT I WISH TO LOOK INTO IT FURTHER FOR MY OWN PERSONAL REASONS (NOT LEGAL ACTION). MY MAIN CONCERN IS THAT WITHIN YOUR DOCUMENTATION FOR DEPUY 2 CEMENT, IT STATES THAT IT IS NOT RECOMMENDED FOR USE ON THE FEMUR NECK, OR HIP USE. CAN YOU PLEASE TELL ME EXACTLY WHY DEPUY 2 IS NOT RECOMMENDING THIS USE AND COULD IT HAVE CONTRIBUTED TO MY MOTHERS FATE? MY MOTHER WAS (B)(6), STILL WORKING. NON DRINKER OR SMOKER, HEALTHY HEART ACCORDING TO THE AUTOPSY. NO TRACE OF REACTION FOUND IN BLOOD SAMPLES, NO EMBOLISM FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11630 DEPUY CMW 2 40G BONE CEMENT LOD DEPUY CMW 3042071

    Patients

    Seq Age Sex Outcome Treatment
    1 Death