BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLOC 133 OFFSET INSERTER ASSY

    MDR report key: 12917719 · Received December 2, 2021

    Report

    Report Number
    0001825034-2021-03262
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    August 23, 2021
    Report Date
    December 2, 2021
    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). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER 20103605 ITEM NAME G7 LONGEVITY NEUTRAL 36MME LOT # 65055382, ITEM NUMBER 110010244 ITEM NAME G7 OSSEOTI 3 HOLE SHELL52MM E LOT # 65048702, ITEM NUMBER 650-0661 ITEM NAME DELTA CERAMIC FEM HD36/0MM LOT # 3063464, ITEM NUMBER 51-107100 ITEM NAME TPRLC 133 MP TYPE1 PPS HO10.0 LOT # 6720772. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. VISUAL INSPECTION OF THE PROVIDED PICTURE IDENTIFIED THE TIP OF THE INSERTER HAD FRACTURED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT 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. INITIALLY INCORRECTLY REPORTED UNDER MFR 0001822565-2021-02528.

    Description of Event or Problem · 0

    IT WAS REPORTED AS THE SURGEON WENT TO USE THE THE FEMORAL IMPACTOR HE NOTICED IT WAS CRACKED. AS HE TOUCHED THE TIP OF THE IMPACTOR, IT FELL OFF. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817130 TLOC 133 OFFSET INSERTER ASSY INSTRUMENT, HIP LPH ZIMMER BIOMET, INC. N/A 073392 00880304509719

    Patients

    Seq Age Sex Outcome Treatment
    1 Female