BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER WITH KINECTIV FEMORAL STEM

    MDR report key: 6116232 · Received November 21, 2016

    Report

    Report Number
    0001822565-2016-04281
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    August 25, 2015
    Report Date
    June 26, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LWJ
    PMA / PMN Number
    PK063251
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A PRODUCT EVALUATION COULD NOT BE CONDUCTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNDETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THESE TYPES OF EVENTS CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDRS HAVE BEEN FILED FOR THIS EVENT. SEE ASSOCIATED REPORTS: 0002648920-2016-04394, 0001822565-2016-04782.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S HIP ARTHROPLASTY WAS REVISED DUE TO METALLOSIS AND ELEVATED COBALT AND CHROMIUM LEVELS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT LEFT TOTAL HIP REVISION APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED OSTEOLYSIS, METALLOSIS, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT WAS REVISED DUE TO ELEVATED COBALT AND CHROMIUM LEVELS, OSTEOLYSIS, AND METALLOSIS. DURING THE PROCEDURE, FLUID, METALLOSIS IN THE TAPER JUNCTION, CALCIFICATION, DEFICIENT ACETABULAR BONE, AND A VERTICAL CUP WITH EXCESSIVE ANTEVERSION WERE NOTED. DUE TO THE BONE OVERGROWTH OF THE STEM, THE PATIENT'S GREATER TROCHANTER ALSO FRACTURED DURING REMOVAL OF THE FEMORAL STEM. CABLES WERE USED TO FIX THE FEMUR. A NEW CUP, LINER, STEM, AND HEAD WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768552 ZIMMER M/L TAPER WITH KINECTIV FEMORAL STEM HIP PROSTHESIS LWJ ZIMMER, INC. N/A 60872628

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R