BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 FREEDOM CONST E1 LNR 32MM C

    MDR report key: 7402800 · Received April 6, 2018

    Report

    Report Number
    0001825034-2018-02431
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    February 28, 2018
    Report Date
    May 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK142882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL DEVICES: ITEM # 010000985, LINER, LOT # 3964905; ITEM # 010000982, LINER, LOT # 6142887.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 DURING A HIP ARTHROPLASTY, THE SURGEON ATTEMPTED TO IMPLANT A POLY LINER IN TO THE PATIENT'S ACETABULUM BY CEMENTING IN THE LINER WITHOUT THE USE OF THE MATING SHELL COMPONENT. THE SURGEON ATTEMPTED TO USE TWO LINERS UNSUCCESSFULLY; THE PROCEDURE WAS COMPLETED WITH A THIRD LINER, WHICH WAS CEMENTED IN, WITHOUT AN ACETABULAR SHELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247449 G7 FREEDOM CONST E1 LNR 32MM C HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 3521075

    Patients

    Seq Age Sex Outcome Treatment
    1