BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER PERIARTICULAR LOCKING SCREW

    MDR report key: 2041965 · Received March 31, 2011

    Report

    Report Number
    1822565-2011-00787
    Event Type
    Injury
    Date Received
    March 31, 2011
    Report Date
    August 27, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IF THE SURGEON BENT THE PLATE (TO FIT TO ANATOMY OF PT) NEAR THE LOCKING HOLE, THE HOLE MIGHT HAVE DEFORMED, POSSIBLY ALLOWING THE SCREW TO BACK OUT. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. 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 THE PT WAS REVISED FOR A LOCKING SCREW THAT BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER PERIARTICULAR LOCKING SCREW TRAUMA PROSTHESIS HWC ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention