BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES POROUS

    MDR report key: 1634515 · Received March 10, 2010

    Report

    Report Number
    2648920-2010-00009
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 9, 2010
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RECEIVED DEVICES WERE REVIEWED. IN THEIR RETURNED CONDITIONS, IT WAS OBSERVED THAT THE TRILOGY CLUSTER-HOLED SHELL HAD SCRATCHES IN SEVERAL PLACES, TWO PATCHES OF SURFACE "DELAMINATION", A CIRCULAR BUFFED MARK CENTERED ABOUT THE POLAR HOLD INDICATING WHERE MATED WITH SHELL IMPACTOR, AND THIRD BODY PARTICLES IN VARIOUS LOCATIONS ON ONE HALF OF THE POROUS SUFACE. THE LOCKING RING HAD THIRD BODY SUBSTANCE AT APEX OF RING, THE SURFACE WAS BUFFED IN VARIOUS LOCATIONS, AND IT WAS BENT IN A "WAVE" PATTERN. WHEN PLACED ON A FLAT SURFACE, THE LOCKING RING TABS AND APEX OF THE RING WERE ON THE SURFACE, WITH THE REMAINING RING BENT UPWARDS TO APPROX 1 MM. THE TRILOGY UHMWPE STANDARD LINER HAD SCRATCHES ON OUTER SURFACE IN VARIOUS LOCATIONS, HAD ONE BUFF MARK IN AN ARCH SHAPE ON OUTER SURFACE LOCATED APPROX 3 CM FROM THE LINER EDGE, THE POLAR BOSS EDGE WAS STRIPPED, THE BOTTOM EDGE OF FLANGE WAS FRACTURED IN A WEDGE SHAPE APPROX 2 CM LONG STARTING AT ONE SCALLOP, AND HAD SCRATCHES ON CHAMFERED EDGE AND FLAT SURFACE OF THE FLANGE LOCATED UNDER "56 X 36" ENGRAVING. IT IS UNK IF THE LINER WAS ATTEMPTED TO BE INSERTED AS PER SURGICAL TECHNIQUE. AS THE SURGICAL NOTES ARE UNAVAILABLE, IT IS MOST LIKELY THAT THE LOCKING RING WAS MISALIGNED IN THE SHELL AND WHEN THE POLY LINER WAS ATTEMPTED TO BE INSERTED, THE LOCKING RING MAY HAVE DEFORMED. THIS MAY HAVE CAUSED THE LOCKING RING TO NOT MATER PROPERLY WITH THE POLY LINER. HOWEVER, THE EXACT CAUSE OF THE CURRENT SITUATION CANNOT BE CONCLUSIVELY DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, 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

    WE WERE UNABLE TO GET 2 DIFFERENT LINERS TO LOCK INTO THIS TRILOGY CLUSTER SHELL. THE SURGEON TRIED FOR 45 MINUTES TO MAKE THIS SHELL WORK. HE CLEANED THE RIM FOR OSTEOPHYTES, CLEANED AND CLEARED ALL SOFT TISSUE, IRRIGATED, AND CHECKED THE SCREW HEADS. THE LINER STILL WOULD NOT LOCK DOWN. AT THAT POINT HE CHOSE TO TAKE THE CUP OUT AND IMPLANT ANOTHER 56 MM TRILOGY CUP, WHICH WAS A MULTI-HOLE BECAUSE THAT IS ALL WE HAD FOR BACK UP. THE LINER LOCKED INTO THIS SHELL JUST FINE. SURGERY WAS PROLONGED BY 45-60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES POROUS HIP PROSTHESIS LPH ZIMMER MANUFACTURING B.V. NA 61381068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK