BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRILOGY HEAD

    MDR report key: 4252940 · Received November 12, 2014

    Report

    Report Number
    1822565-2014-01565
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    May 30, 2012
    Report Date
    October 14, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES 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 AGE, BONE QUALITY, HEIGHT/WEIGHT, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICES CAUSED OR CONTRIBUTED TO PT INFECTION. CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND 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.

    Description of Event or Problem · 1

    IT IS REPORTED THE PT UNDERWENT A TWO STAGE REVISION DUE TO PAIN AND INFECTION. IT IS REPORTED THE SURGICAL REPORT INDICATED A PSEUDOCAPSULE WAS UNDER SEVERE PRESSURE AND BURST UPON INCISION, CORROSION OF THE MORSE TAPER, AND THE LOCKING RING SHIFTING AND BECOMING IMMOBILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729565 ZIMMER TRILOGY HEAD HIP PROSTHESIS LZO ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK ZIMMER TRILOGY LINER, CATALOG UNK, LOT UNK