BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLOC 133 OFFSET INSERTER ASSY

    MDR report key: 12447575 · Received September 9, 2021

    Report

    Report Number
    0001822565-2021-02528
    Event Type
    Malfunction
    Date Received
    September 9, 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

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 0001825034 - 2021 - 03262

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 0001825034 - 2021 - 03262

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (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. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS LOCATION UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AS THE SURGEON WENT TO USE 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
    1343089 TLOC 133 OFFSET INSERTER ASSY INSTRUMENT, HIP LPH ZIMMER BIOMET, INC. N/A 073392 00880304509719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown