BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULS RECON PLATE

    MDR report key: 1884132 · Received October 21, 2010

    Report

    Report Number
    1822565-2010-00969
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PACKAGE INSERT WARNS OF THESE COMPLICATIONS WHICH CAN RESULT DUE TO PATIENT'S POST-OP ACTIVITIES. PATIENT DETAILS LIKE AGE, HEIGHT, WEIGHT ETC ARE UNKNOWN. NO X-RAYS SHOWING TYPE OF FRACTURE AND PLATE BREAKAGE WERE RETURNED. THE DEVICE STATED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. MOST LIKELY THE PATIENT'S FALL RESULTED IN THE PLATE BREAKAGE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. 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 IS REPORTED THAT THE PLATE BROKE WHEN THE PATIENT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULS RECON PLATE TRAUMA PROSTHESIS HRS ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention