BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL MODULAR SHELL

    MDR report key: 1930038 · Received November 18, 2010

    Report

    Report Number
    1822565-2010-01154
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THE RETURNED DEVICES HAVE BEEN REVIEWED AND THE FOLLOWING OBSERVATIONS WERE MADE: THE SHELL INCLUDES THE REPLACEMENT LOCKING RING LISTED ABOVE. THE INNER DIAMETER OF THE SHELL SHOWS RING MARK AROUND THE DOME HOLE AND A SCRATCH. THE LOCKING RING IN THE SHELL HAS DAMAGE AT THE TABS AND SHOWS A SLIGHT BEND. THE FIRST LINER SHOWS A MATCHING SCRATCH ON THE OUTER DIAMETER COMPARED TO THE ONE ON THE SHELL. THE SECOND LINER SHOWS DAMAGE ON THE POLAR BOSS, A CRACK ON THE RIM, AND A SCRATCH. AS RETURNED, THE IMPLANTS CONFORM TO SPECIFICATIONS WHERE MEASURED. IT IS UNK WHETHER THE SHELL WAS IMPLANTED WITH THE CORRECT FIT AND ORIENTATION PER SURGICAL TECHNIQUE. INSTRUMENTATION USED IS UNK. BASED ON THE ABOVE INFO, IT IS POSSIBLE THAT THE INABILITY TO SEAT EITHER LINER IN THE SHELL AND THE DEFORMATION OF THE LOCKING RINGS MAY HAVE BEEN CAUSED BY ONE OR A COMBINATION OF THE FOLLOWING: DAMAGE TO THE RING DURING SHELL IMPACTION, MIS-ALIGNMENT OF THE LOCKING RING, SOFT TISSUE IMPINGEMENT, MIS-ALIGNMENT OF THE LINER IN THE SHELL. THE DAMAGE TO THE SECOND LINER MAY ALSO HAVE BEEN CAUSED BY THE TOOLS AND FORCE USED TO REMOVE THE LINER FROM THE SHELL. HOWEVER, THE EXACT CAUSE OF THIS SITUATION CANNOT BE DETERMINED WITH CERTAINTY. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON COULD NOT LOCK THE LINER INTO THE SHELL BECAUSE THE LOCKING RING WAS WARPED. THE SURGEON REPLACED THE LOCKING RING AND REQUESTED ANOTHER LINER. HOWEVER, HE COULD NOT GET THE SECOND LINER TO LOCK INTO THE SHELL EITHER. THEREFORE, THE SURGEON REMOVED BOTH THE SHELL AND THE LINER AND PROCEEDED TO IMPLANT ANOTHER SHELL AND LINER WITHOUT ANY FURTHER ISSUES. SURGERY WAS DELAYED BY 60 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL MODULAR SHELL HIP PROSTHESIS KWB ZIMMER, INC. 61539583

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR TRILOGY ACETABULAR SYSTEM TRABECULAR METAL MODULAR| TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED| CROSSLINKED POLYETHYLENE, CATALOG #00634104832,| TRILOGY ACETABULAR SYSTEM LINER LONGEVITY| LOT #60878018| LOT #60912605| POLYETHYLENE LINER, CATALOG #00634104832,| REPLACEMENT LOCKING RING, CATALOG #00620104800,| LOT #60113579