BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 36MM RLC LNR MROM SZ24

    MDR report key: 7758222 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-04809
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    December 20, 2013
    Report Date
    October 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 103533 TI LOW PROFILE SCREW 6.5X30MM LOT# 998640. 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 - 2018 - 09734, 0001825034 - 2018 - 09741.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034 - 2018 - 04806; 0001825034 - 2018 - 04807; 0001825034 - 2018 - 04808; 0001825034 - 2018 - 04810. CONCOMITANT MEDICAL PRODUCTS: 51-107110, TAPERLOC STEM, LOT 2921960; 11-363660, FEMORAL HEAD, LOT 923630; 13-104154, RLC SHELL, LOT 743650; 103531, SCREW, LOT 2838103. REPORTED INFECTION AND FEMORAL STEM LOOSENING EVENT CONFIRMED DUE TO MEDICAL RECORDS RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS SEVERE PAIN, GROSS INFECTION, AND LACK OF FEMORAL STEM IN-GROWTH. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601092 EPOLY 36MM RLC LNR MROM SZ24 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R