BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 STR MODULAR SHELL INSERTER

    MDR report key: 20453013 · Received October 15, 2024

    Report

    Report Number
    0001825034-2024-02430
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 25, 2024
    Report Date
    February 12, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    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 G7 STR INSRTR THREADED SHAFT 083622. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H3, H6, H10. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE THREADED SHAFT HAS A DEFORMATION DAMAGE TO THE THREAD. NO IMAGES WERE PROVIDED OF THE INSERTER. THE ITEMS WERE DISCARDED AT THE USER FACILITY; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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 COMPLAINT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MODULAR INSERTER AND SHAFT ARE DAMAGED. UNABLE TO THREAD AND UNTHREAD SHAFT IN AND OUT OF INSERTER. THE PIECE WAS ASSEMBLED AND WAS NOT ABLE TO BE DISASSEMBLED WITHOUT MUCH FORCE OR POSSIBLE FARTHER DAMAGE. THERE WAS NO IMPACT ON SURGERY. SURGERY WAS COMPLETED WITH ORIGINAL DEVICE.

    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
    316708 G7 STR MODULAR SHELL INSERTER HIPS, INSTRUMENTS PBI ZIMMER BIOMET, INC. N/A 65771333 00887868462498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11 NARRATIVE