BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBILE LINER INT 28 MM 42 MM

    MDR report key: 10271046 · Received July 14, 2020

    Report

    Report Number
    3008021110-2020-00053
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    June 6, 2020
    Report Date
    December 4, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LZO
    PMA / PMN Number
    K181491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    REVISION SURGERY OF HIP REPLACEMENT DUE TO INFECTION PERFORMED ON (B)(6) 2020. DURING REVISION SURGERY, MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420, LOT#: 19AT3YM - STER.2000140), LINER#: L FOR MOBILE LINER Ø42 (PRODUCT CODE: 5885.09.042, LOT#: 1914849 - STER.1900380) AND THE FEMORAL HEAD (NOT MANUFACTURED BY LIMA) WERE REPLACED AND A FULL WASH OUT WAS PERFORMED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020 AND WAS DUE TO PERIPROSTHETIC FRACTURE. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2012. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE LOT#19AT3YM - STER.2000140 AND LOT#1914849 - STER.1900380, NO PRE-EXISTING ANOMALY WAS DETECTED AND THE ALL COMPONENTS MANUFACTURED AND STERILIZED WITH THESE LOT #S. THEREFORE, WE CAN ENSURE THAT ALL THE COMPONENTS WERE CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. FIRST AND ONLY COMPLAINT RECEIVED ON THESE STERILIZATION NUMBERS. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY OF HIP REPLACEMENT DUE TO INFECTION PERFORMED ON (B)(6) 2020. DURING REVISION SURGERY, MOBILE LINER INT 28 MM 42 MM (PRODUCT CODE 5566.50.420, LOT#19AT3YM - STER.2000140), LINER #L FOR MOBILE LINER 42 (PRODUCT CODE 5885.09.042, LOT#1914849 - STER.1900380) AND THE FEMORAL HEAD (NOT MANUFACTURED BY LIMA) WERE REPLACED AND A FULL WASH OUT WAS PERFORMED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020 AND WAS DUE TO PERIPROSTHETIC FRACTURE. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2012. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734538 MOBILE LINER INT 28 MM 42 MM MOBILE LINER DIA.INT.28MM DIA.EXT.42MM (LZO, LPH, MBL), LZO LIMACORPORATE SPA 5566.50.420 19AT3YM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention