BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLOC 133 OFFSET INSERTER ASSY

    MDR report key: 18226808 · Received November 29, 2023

    Report

    Report Number
    0001825034-2023-02787
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 8, 2023
    Report Date
    March 19, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304509719
    PMA / PMN Number
    K120030
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE TLOC 133 OFFSET INSERTER ASSY ITEM# 51-222224 LOT# 057777 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE TIP OF THE DEVICE HAD FRACTURED FROM THE DEVICE. THERE ARE INDENTATIONS TO THE STRIKE PLATE. 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. THE EVENT IS CONFIRMED VIA RETURNED PRODUCT. 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

    DURING IMPACTION OF THE FEMORAL COMPONENT, THE INSERTER BROKE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982526 TLOC 133 OFFSET INSERTER ASSY INSTRUMENT, HIP LPH ZIMMER BIOMET, INC. N/A 057777 00880304509719

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male