BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 STR INSRTR THREADED SHAFT

    MDR report key: 12569338 · Received October 4, 2021

    Report

    Report Number
    0001825034-2021-02810
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 13, 2021
    Report Date
    January 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K121874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A G7 BALL HEX DRVR FOR INSR HNDL, PART # 010002736 FROM LOT 057745, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE BALL HEX FEATURE TO HAVE FRACTURED FROM THE SHAFT. PITS AND SCRATCHING ARE PRESENT ON THE HANDLE AS WELL AS SURFACE SCRATCHING AND WEAR RINGS ON THE SHAFT. A G7 STR INSRTR THREADED SHAFT, PART # 110003452 FROM LOT 493623, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND BOTH HEX FEATURES TO BE NICKED AND SCRATCHED. SCRATCHING AND WEAR RINGS ARE PRESENT ON THE SHAFT. THE THREADS EXHIBIT NO SIGNIFICANT DAMAGE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT 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). 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. PART #: 010002736 / G7 BALL HEX DRVR/ LOT # 057745. PAR T#: 010000663/ G7 PPS LTD ACET SHELL /LOT# 7061683. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02808, 0001825034-2021-02811.

    Description of Event or Problem · 1

    IT WAS REPORTED AS THE SURGEON IMPACTED G7 PPS CUP AND ATTEMPTED TO UNSCREW THE INSERTER FROM THE IMPLANT. THE INSTRUMENT WOULD NOT UN-COUPLE FROM THE SHELL. THE SURGEON PUT A TOMMY BAR THROUGH SCREW DRIVER SHAFT TO ASSIST AND THE BALL HEX DRIVER TIP BROKE OFF INSIDE. THE CUP WAS IMPLANTED AND NOT AFFECTED BY THE SCREW DRIVER BREAKAGE. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467637 G7 STR INSRTR THREADED SHAFT INSTRUMENT, HIP LPH ZIMMER BIOMET, INC. NI 493623

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male SEE H10