BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISIONAL LINER LOCKING SCREW

    MDR report key: 2193066 · Received July 22, 2011

    Report

    Report Number
    1822565-2011-01680
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE PROVISIONAL LOCKING SCREW WAS DESIGNED SO THAT IT CAN BE ASSEMBLED AND DISASSEMBLED FROM THE PROVISIONAL LINER FOR DEVICE REPROCESSING. IT IS POSSIBLE THAT THE SURGEON DID NOT HAVE THE AXIS OF THE SCREW ALIGNED WITH THE MATING THREADS OF THE SHELL OR THE LINER WAS NOT ALL THE WAY SEATED IN THE SHELL MAKING INSERTION OF THE SCREW DIFFICULT. IT IS UNK IF INSTRUCTIONS PER THE SURGICAL TECHNIQUE WERE FOLLOWED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVAL: 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 SPECS. 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 RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY MATING THE PROVISIONAL LOCKING SCREW WITH THE PROVISIONAL LINER. AS THE SCREW WAS BEING REMOVED, IT FELL INTO THE SURGICAL WOUND AND WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISIONAL LINER LOCKING SCREW LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR