BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAPERLOC POR FMRL 12.5X145

    MDR report key: 6968884 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09585
    Event Type
    Death
    Date Received
    October 23, 2017
    Date of Event
    August 26, 2015
    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 PRODUCTS: BIOLOX DELTA XLW-18 INS 32/39G CATALOG# 650-0791 LOT#2240588, BIOLOX D MOD CER HD 32MM STD CATALOG#164186 LOT#2264338, EXCEED ABT 3HL SHELL 39/52MM M CATALOG#123952 LOT 2111623. 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 OPERATION. THERE IS NO INFORMATION TO SUGGEST THE DEVICES CONTRIBUTED TO THE PATIENT'S DEATH, HOWEVER CAUSE OF DEATH REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748614 TAPERLOC POR FMRL 12.5X145 KNEE, PROSTHESIS LPH ZIMMER BIOMET, INC. 257400

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death