BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER RECONSTRUCTION BONE PLATE - STRAIGHT

    MDR report key: 2041928 · Received March 31, 2011

    Report

    Report Number
    1822565-2011-00788
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    April 29, 2009
    Report Date
    September 23, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THERE IS NOT ENOUGH INFO PROVIDED ABOUT THE CONDITIONS THE PLATE WAS SUBJECTED TO AT THE TIME OF THE INITIAL SURGERY OR DURING THE TIME LEADING TO THE DEVICE FRACTURE TO DETERMINE THE POTENTIAL ROOT CAUSE OF THIS INCIDENT. 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 INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE, IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE PT HAD HER STITCHES REMOVED, IT WAS FOUND THAT THE PLATE WAS BROKEN AND THE WOUND WAS STILL NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER RECONSTRUCTION BONE PLATE - STRAIGHT HRS ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R