BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP FMRL 5.0MM

    MDR report key: 8119954 · Received November 30, 2018

    Report

    Report Number
    0001825034-2018-10985
    Event Type
    Injury
    Date Received
    November 30, 2018
    Date of Event
    June 29, 2015
    Report Date
    November 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K050441
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A 38MM MOD; P/N: 11-173661, L/N: 717020; M2A 38MM MOD; P/N: 11-173661, L/N: 040260; TAPERLOC MICROP FMRL; P/N: 14-103200, L/N: 746180; TAPERLOC POR FMRL 5.0X130; P/N: 103200, L/N: 080530; M2A-MAGNUM PF CUP 44ODX38ID; P/N: US157844, L/N: 511670; M2A-MAGNUM PF CUP 44ODX38ID; P/N: US157844, L/N: 857110. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A PICTURE OF THE EXPLANTED HEAD FROM THE RIGHT HIP, WAS PROVIDED. A DAMAGE MARK WAS FOUND ON THE BOTTOM OF THE HEAD. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2015 - 02994 - 4, 0001825034 - 2015 - 04786 - 2, 0001825034 - 2018 - 10985.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL BILATERAL HIP ARTHROPLASTY 9 YEARS POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT WAS REVISED 3 YEARS AGO DUE TO ELEVATED METAL ION, PAIN, INFLAMMATION, AND LIMITED RANGE OF MOTION LEVELS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960647 TAPERLOC MICROP FMRL 5.0MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 746180

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R