BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET G7 LINER

    MDR report key: 7346620 · Received March 16, 2018

    Report

    Report Number
    0001825034-2018-01867
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    October 11, 2017
    Report Date
    November 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON VISUAL INSPECTION, THERE WAS DEFORMATION TO THE SCALLOPS AND LOCKING FEATURE OF THE LINER. NO FURTHER MEASUREMENTS WERE TAKEN AS THE ORDER WAS CHECKED 100% DURING PRODUCTION. 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). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 110017104, FINNED CUP, LOT # 6061019, ITEM # 010000819, LINER, LOT # 6029243. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01866, 0001825034-2018-01867, 0001825034-2018-01868.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE LINERS WOULD NOT LOCK INTO THE SHELL. THE EVENT OCCURRED DURING A PRIMARY HIP SURGERY CAUSING A DELAY GREATER THAN 30 MINUTES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190295 BIOMET G7 LINER HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 6065078

    Patients

    Seq Age Sex Outcome Treatment
    1 Other