BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 STR MODULAR SHELL INSERTER

    MDR report key: 20079518 · Received August 27, 2024

    Report

    Report Number
    0001825034-2024-02096
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 6, 2024
    Report Date
    January 16, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868462498
    PMA / PMN Number
    K121874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110003452, ITEM NAME G7 STR INSRTR THREADED SHAFT, LOT # 083622. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4 G3 G6 H2 H6 H11 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UNABLE TO CONFIRM THE EVENT. 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 THE THREADED SHAFT IS STUCK INSIDE THE MODULAR SHELL INSERTER. INTERNAL THREADS ARE DAMAGED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179266 G7 STR MODULAR SHELL INSERTER INSTRUMENT, HIP LPH ZIMMER BIOMET, INC. N/A 65771333 00887868462498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male PLEASE SEE H11