BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAPERLOC POR FMRL 10X140

    MDR report key: 6968868 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09595
    Event Type
    Death
    Date Received
    October 23, 2017
    Date of Event
    January 28, 2014
    Report Date
    October 23, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOLOX DELTA LNR 36MM 54-56MM, CATALOG# 650-0795, LOT# 2084697; DELTA CERAMIC FEM HD 36/-3MM, CATALOG# 650-0660, LOT# 1708280; EXCEED ABT 3HL SHELL 44/54MM, CATALOG# 124454, LOT# 1576413. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN REASONS FOUR YEARS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748461 TAPERLOC POR FMRL 10X140 KNEE, PROSTHESIS LPH ZIMMER BIOMET, INC. 259620

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death