BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 BALL HEX DRVR FOR INSR HNDL

    MDR report key: 13367838 · Received January 27, 2022

    Report

    Report Number
    0001825034-2022-00195
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    January 4, 2022
    Report Date
    March 22, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304926820
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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 # 110010247/ G7 OSSEOTI 4 HOLE SHELL 58MM/ LOT # UNKNOWN. ITEM # 110003451/ G7 STR MODULAR SHELL INSERTER/ LOT # 494810. ITEM # 110003452/ G7 STR INSRTR THREADED SHAFT/ LOT # 072082. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2022 -00197, 0001825034 -2022 -00199, AND 0001825034 -2022 -00200.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION OF THE RETURNED HANDLE FOUND THE BALL HEX TRIP TO BE FRACTURED. OXIDATION SPOTS WERE OBSERVED ON THE SHAFT AND GRIP. SURFACE SCRATCHES ARE ALSO PRESENT ON THE SHAFT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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

    IT WAS REPORTED THAT DURING A HIP PROCEDURE THE CUP INSERTION HANDLE COULD NOT BE LOOSENED FROM CUP. TOMMY BAR WAS USED WITH G7 BALL TIP SCREW DRIVER TO TRY TO RELEASE CUP. G7 BALL DRIVER BROKE AT TIP AND INSERTION HANDLE WAS STILL ATTACHED TO CUP IN PATIENT. WHOLE CONSTRUCT WAS REMOVED. NO ADVERSE EVENTS WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112680 G7 BALL HEX DRVR FOR INSR HNDL INSTRUMENT, HIP LPH ZIMMER BIOMET, INC. NI 062100 00880304926820

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male