BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BALL HEX DRVR FOR INSR HNDL

    MDR report key: 7826661 · Received August 29, 2018

    Report

    Report Number
    0001825034-2018-08564
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 6, 2018
    Report Date
    May 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CONCOMITANT MEDICAL PRODUCTS: 110003451, G7 STR MODULAR SHELL INSERTER, 423350, 110010247, G7 OSSEOTI 4 HOLE SHELL 58MM G, 3973486. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08565, 0001825034-2018-08566. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE THE HEX DRIVER SNAPPED OFF AND BROKE. THIS LEFT THE SHELL INSERTER STUCK TO THE IMPLANTED SHELL WITH NO WAY TO REMOVE. THE SHELL WAS THEN EXPLANTED AND A DIFFERENT SHELL WAS IMPACTED USING A DIFFERENT INSERTER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668296 G7 BALL HEX DRVR FOR INSR HNDL PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 395400

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention