BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER TRILOGY LINER

    MDR report key: 4092589 · Received September 4, 2014

    Report

    Report Number
    1822565-2014-01073
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. EVALUATION SUMMARY: X-RAYS FROM AFTER THE REVISION STILL SHOW THE PLACEMENT OF THE ORIGINAL ACETABULAR SHELL AND FEMORAL SIDE COMPONENTS, WHICH APPEAR THAT THE SHELL MAY NOT HAVE BEEN IMPLANTED IN THE APPROPRIATE VERSION ANGLE. THE PATIENT'S REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. THE PATIENT'S ACTIONS DURING THE TIME OF THE RECURRENT DISLOCATIONS IS UNKNOWN, IT CANNOT BE DETERMINED WHETHER THE PATIENT ABIDED BY THA POST OPERATIVE INDICATIONS. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: 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 SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT INSTABILITY AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542029 UNKNOWN ZIMMER TRILOGY LINER HIP PROSTHESIS LZO ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention IMPLANTED.| UNK ZIMMER FEMORAL HEAD, CATALOG# UNK, LOT# UNK| UNK TRILOGY SHELL, CATALOG# UNK, LOT# UNK-REMAINS