BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 36MM F

    MDR report key: 7337169 · Received March 14, 2018

    Report

    Report Number
    0001825034-2018-01839
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    October 7, 2013
    Report Date
    April 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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). MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034 - 2018 - 01836, 0001825034 - 2018 - 01837, 0001825034 - 2018 - 01838. CONCOMITANT MEDICAL PRODUCTS: 010000665 G7 PPS LTD ACET SHELL 56F LOT 2981561, 12-115120 CER BIOLOXD MOD HD 36MM -3 NK LOT 725740, 51-103130 TPRLC 133 TYPE1 PPS SO 13.0 LOT 2835744. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED 1500 ML BLOOD LOSS DURING THE PRIMARY RIGHT TOTAL HIP ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182594 G7 NEUTRAL E1 LINER 36MM F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3078828

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other