BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEPUY CMW HIGH VISCOSITY BONE CEMENT 40G

    MDR report key: 2485377 · Received March 9, 2012

    Report

    Report Number
    1818910-2012-05762
    Event Type
    Death
    Date Received
    March 9, 2012
    Date of Event
    October 7, 2011
    Report Date
    February 8, 2012
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K053003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING COMPLAINT REVIEW BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINED - FROM THE LIMITED INFORMATION AVAILABLE IT IS NOT POSSIBLE TO SAY WHAT HAS OCCURRED OR WHY. IT IS UNLIKELY THAT THE DEATH IS RELATED DIRECTLY TO THE IMPLANT DESIGN. NO INFORMATION IS PROVIDED TO CONFIRM THAT METALLOSIS WAS PRESENT. METALLOSIS HAS NOT PREVIOUSLY BEEN REPORTED FOR THE PRODUCT COMBINATION HASTINGS HEAD/C-STEM AND IT IS NOT LIKELY THAT THE DEVICE WOULD HAVE CAUSED A METALLOSIS ISSUE IN THE SHORT IMPLANTATION PERIOD AND BASED ON AVAILABLE PATIENTS PAST MEDICAL HISTORY. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. PATIENT DEMOGRAPHICS WERE NOT MADE AVAILABLE. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    DEATH. HIP REPLACEMENT ON (B)(6) 2011. BIPOLAR HEMIARTHROPLASTY. DISCHARGED FROM HOSPITAL (B)(6) 2011. ALLEGED DEATH ON (B)(6) 2011 DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY CMW HIGH VISCOSITY BONE CEMENT 40G BONE CEMENT LOD DEPUY CMW 3276582

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death