BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FINNED PRI STEM 40MM

    MDR report key: 9080975 · Received September 18, 2019

    Report

    Report Number
    0001825034-2019-04141
    Event Type
    Injury
    Date Received
    September 18, 2019
    Date of Event
    August 30, 2019
    Report Date
    September 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-01446. CONCOMITANT MEDICAL PRODUCTS: BMET REGENX PRI TIB TRAY 79MM ITEM# 141275 LOT# 158670, SERIES A PAT STD 37 3 PEG ITEM# 184768 LOT# 359540, VANGUARD CR POR FMRL-LT 75 ITEM# 183074 LOT# 556910, E1 VNGD AS TIB BRG 10X79 ITEM# EP-189100 LOT# 708490. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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 A PATIENT WAS REVISED APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO LOOSENING OF THE TIBIAL IMPLANT. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874840 BIOMET FINNED PRI STEM 40MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 362180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R