BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBILE LINER INT 28 MM 42 MM

    MDR report key: 10669210 · Received October 13, 2020

    Report

    Report Number
    3008021110-2020-00084
    Event Type
    Injury
    Date Received
    October 13, 2020
    Date of Event
    February 5, 2020
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K181491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOTS #1110897 AND #1109921, NO PRE-EXISTING ANOMALIES WERE DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THESE LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY DUE TO PAIN PERFORMED ON (B)(6) 2020. NECROSIS WAS FOUND AROUND THE FEMORAL STEM. THE FOLLOWING COMPONENTS WERE EXPLANTED: FEM. MODULAR HEAD - M Ø28MM (PRODUCT CODE 5010.05.282, LOT #1110897) - PRODUCT NOT MARKETED IN THE US. MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420, LOT #1109921). H-MAX M HIP - STEM #9 (PRODUCT CODE 4205.20.090, LOT #1108103) - PRODUCT NOT MARKETED IN THE US. MODULAR NECK LAT-S (S4) - TAPER 12/14 (PRODUCT CODE 4225.09.110) - PRODUCT NOT MARKETED IN THE US. ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A MOBILITY PROBLEM DUE TO WEAR AND TEAR OF THE MOBILE LINER, WHICH GOT STUCK ONTO THE HEAD. H-MAX M STEM AND DOUBLE MOBILITY CUP WERE IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2012. EVENT HAPPENED IN (B)(6). INITIALLY ONLY PRODUCT CODE AND LOT # OF THE FEM. MODULAR HEAD WERE AVAILABLE (THE PRODUCT IS NOT MARKETED IN THE US). THE INFORMATION ON CODE AND LOT# OF THE MOBILE LINER WERE PROVIDED WITH DELAY BY THE COMPLAINT SOURCE, THEREFORE THE INCIDENT IS REPORTED TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133454 MOBILE LINER INT 28 MM 42 MM MOBILE LINER DIA.INT.28MM DIA.EXT.42MM LZO LIMACORPORATE S.P.A. 5566.50.420 1109921

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention