BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL LAT 10X140

    MDR report key: 8549092 · Received April 25, 2019

    Report

    Report Number
    0001825034-2019-01868
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    January 30, 2017
    Report Date
    April 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. AN OP NOTE FOR THE REVISION DEMONSTRATED THAT THE PATIENT UNDERWENT A WASHOUT AND EXTENSIVE INFECTION WAS FOUND. THERE WAS ALSO METAL STAINED TISSUE THAT WAS NECROTIC AND INFECTIOUS. PATIENT WAS REVISED AND SPACER AND BIPOLAR MODULAR HEAD WERE IMPLANTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A ROOT CAUSE REMAINS UNDETERMINED. 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. CONCOMITANT MEDICAL PRODUCTS: 157446, M2A-MAGNUM MOD HD SZ 46MM, LOT 912700, US157852, M2A-MAGNUM PF CUP 52ODX46ID, LOT 573100, 139252, M2A-MAGNUM 42-50MM TPR INSRT-6, LOT 789490. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04880, 0001825034-2017-04883.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 7 YEARS POST IMPLANTATION, THE PATIENT HAD DEVELOPED PAIN AND WEAKNESS IN THE HIP. THE PATIENT UNDERWENT A WASHOUT OF THE JOINT DUE TO INFECTION, AND A 2-STAGE REVISION OF THE IMPLANTS. THERE WAS ALSO LARGE AMOUNTS OF METAL STAINED SOFT TISSUE THAT WAS NECROTIC AND INFECTIOUS, ALONG WITH A LARGE CYST ALONG THE FEMORAL STEM, RESULTING IN THE REMOVAL OF THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342080 TAPERLOC POR FMRL LAT 10X140 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 670290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R