BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FREEDOM CONSTRAINED E1 LINER 36MM F

    MDR report key: 7469962 · Received April 27, 2018

    Report

    Report Number
    0001825034-2018-02579
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    April 2, 2018
    Report Date
    November 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. UPON VISUAL INSPECTION THE ITEMS WERE STUCK TOGETHER AND COULD NOT BE SEPARATED DUE TO THIS, NO FURTHER MEASUREMENTS WERE TAKEN. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3 WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM# 110010245 G7 OSSEOTI 4 HOLE SHELL 54 MM F LOT# 6222888. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02578.

    Description of Event or Problem · 1

    DURING A TOTAL HIP ARTHROPLASTY THE PHYSICIAN HAD DIFFICULTY SEATING THE LINER IN THE CUP. PATIENT EXPERIENCED FRACTURED PELVIS DURING THE ATTEMPT TO SEAT THE LINER. ADDITIONAL INFORMATION REQUESTED AND RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311299 G7 FREEDOM CONSTRAINED E1 LINER 36MM F HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 6159284

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other