BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 CURVED INSERTER THD SHAFT

    MDR report key: 23180166 · Received September 30, 2025

    Report

    Report Number
    0001825034-2025-03045
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 8, 2025
    Report Date
    February 18, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00887868462528
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; D9; G3; H2; H3; H4; H6. D4: LOT NUMBER, 083625. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED CONFIRMED ETCH IDENTIFICATION; HEX, THREADS, AND SLOT WERE GOUGED AND SCRATCHED FROM PREVIOUS USE; THE LEADING THREAD WAS DEFORMED AND FRACTURED AWAY BUT REMAINED CONNECTED ON BOTH ENDS OF THE BROKEN SECTION. MEASUREMENTS WITHIN SPECIFICATION, APPROXIMATE FIELD AGE OF 3 YEARS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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 TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: CANADA. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THREADS ON THE G7 INSERTER ARE DAMAGED, PREVENTING THE USE OF THE SCREW. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214870 G7 CURVED INSERTER THD SHAFT PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 083625 00887868462528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown