BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRILOGY LINER

    MDR report key: 4780227 · Received May 18, 2015

    Report

    Report Number
    1822565-2015-00717
    Event Type
    Injury
    Date Received
    May 18, 2015
    Date of Event
    March 11, 2015
    Report Date
    April 16, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES AND X-RAYS WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: THE PART NUMBERS AND LOT NUMBERS OF THE PRODUCTS ARE UNK; THEREFORE THE MFG RECORDS, COMPLAINT HISTORY COULD NOT BE REVIEWED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNK. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    OTHER DEVICE USED: CATALOG #UNKNOWN, UNKNOWN TRILOGY LINER, LOT #UNKNOWN, CATALOG #UNKNOWN, UNKNOWN VERSYS STEM, LOT #UNKNOWN. SURGICAL NOTES, DATED (B)(6) 2001, STATE THAT THE THA WAS FOR END-STAGE OSTEOARTHRITIS. THE FINAL REDUCTION WAS NOTED TO HAVE EXCELLENT STABILITY AND IMPROVED LEG LENGTH. NO COMPLICATION WERE NOTED. SURGICAL NOTES, DATED (B)(6) 2015, STATED THAT THE PATIENT WAS REVISED FOR POLYETHYLENE WEAR AND OSTEOLYSIS. THE PATIENT HAD FLUID AND OSTEOLYSIS AROUND THE HIP. THERE WAS MAJOR POLYETHYLENE WEAR AND CORROSION AROUND THE FEMORAL NECK AT THE HEAD NECK JUNCTION NOTED. MAJOR OSTEOLYTIC LESION OF THE GREAT TROCHANTER WAS ALSO NOTED. THIS WAS REPAIR WITH A BONE GRAFT. THE FINAL REDUCTION AFTER REVISION WAS NOTED TO HAVE EXCELLENT STABILITY. NO COMPLICATIONS WERE NOTED. WITH THE PROVIDED INFORMATION IT APPEARS THAT THE OSTEOLYSIS MAY HAVE BEEN FROM THE POLYETHYLENE WEAR OVER THE 14 YEARS OF USE. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THESE DEVICES HAVE BEEN USED IN THE TREATMENT OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO DEBRIS AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321444 UNKNOWN TRILOGY LINER HIP PROSTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention