BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLOC 133 OFFSET INSERTER ASSY

    MDR report key: 15542937 · Received October 5, 2022

    Report

    Report Number
    0001825034-2022-02267
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 14, 2022
    Report Date
    November 9, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304509719
    PMA / PMN Number
    K120030
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE TLOC 133 OFFSET INSERTER ASSY ITEM# 51-222224 LOT# 064417 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE TIP OF THE INSERTER HAD FRACTURED. THE POMMEL OF THE DEVICE SHOWS SCUFFING AND IMPACT MARKS. A REVIEW OF THE DEVICE HISTORY RECORDS 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 FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED HE OFFSET TAPERLOC STEM IMPACTOR BROKE DURING FEMORAL STEM IMPACTION. NO ADDITIONAL INFORMATION AVAILABLE ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556116 TLOC 133 OFFSET INSERTER ASSY PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 064417 00880304509719

    Patients

    Seq Age Sex Outcome Treatment
    1 Male