BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER DOUGH-TYPE BONE CEMENT

    MDR report key: 2063195 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00687
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: A REVIEW OF THE COMPLAINT HISTORY DID NOT REVEAL ANY OTHER SIMILAR COMPLAINTS. THE CONDITION OF THE MIXING BOWL PRIOR TO MIXING THE MONOMER AND POLYMER IS UNKNOWN. SINCE THE PROCESS OF FILLING THE (B)(6) IS CAPABLE OF REMOVING PARTICLES SMALLER THAN THOSE REPORTED WITHIN THE COMPLAINT, IT IS HIGHLY UNLIKELY THAT THE PARTICLES CAME FROM THE MONOMER. THE PARTICLES WERE NOT RETURNED SO THE COMPOSITION COULD NOT BE ANALYZED. WITH THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED CONDITION CANNOT BE DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON FOUND REDDISH BROWN PARTICLES IN THE MONOMER LIQUID ADDED TO THE POLYMER IN THE BOWL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER DOUGH-TYPE BONE CEMENT BONE CEMENT LOD ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1