BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER INTERNAL FIXATION PLATE

    MDR report key: 2023242 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00618
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A JOURNAL ARTICLE. EVALUATION SUMMARY: INFORMATION IS NOT SUFFICIENT TO MAKE AN APPROPRIATE DETERMINATION ON THE FAILURE. 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 A PATIENT DEVELOPED A NON-UNION COMPLICATED BY BREAKAGE OF THE INTERNAL FIXATION PLATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention