BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 58MM G

    MDR report key: 13367847 · Received January 27, 2022

    Report

    Report Number
    0001825034-2022-00197
    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
    OQI
    PMA / PMN Number
    K140669
    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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 010002736/ G7 BALL HEX DRVR FOR INSR HNDL/ LOT # 062100. 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 -00195, 0001825034 -2022 -00199, AND 0001825034 -2022 -00200.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H6 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. DHR WAS UNABLE TO BE REVIEWED AS THE LOT NUMBER FOR THE DEVICE IS UNKNOWN. 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
    112688 G7 OSSEOTI 4 HOLE SHELL 58MM G PROSTHESIS, HIP OQI ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male