BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 40MM +3 MAXROM LNR SZ24

    MDR report key: 7339122 · Received March 14, 2018

    Report

    Report Number
    0001825034-2018-01788
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    August 11, 2011
    Report Date
    October 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: (B)(4), SELEX/MAGNUM MOD HD 40MM +3 LOT# 971510; ITEM# (B)(4), BI-METRIC POR FMRL 9.0X250MML, LOT# 384650. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS WHICH INDICATED ESTIMATED BLOOD LOSS WAS ABOUT 1400 ML DURING PROCEDURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 11-301303, ARCOS CON SZ C STD 60MM, 163470, S001140, SELEX/MAGNUM MOD HD 40MM STD, 626430. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01787, 0001825034 - 2018 - 01789. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD LOSS OF 1400 ML DURING A STAGE II REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183120 E-POLY 40MM +3 MAXROM LNR SZ24 PROSTHESIS, HIP MAY ZIMMER BIOMET, INC. N/A 878960

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O