BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBILE LINER DIA.INT.28MM DIA.EXT.40MM

    MDR report key: 17286019 · Received July 10, 2023

    Report

    Report Number
    3008021110-2023-00081
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    June 16, 2023
    Report Date
    July 10, 2023
    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 · 0

    NO PRE-EXISTING ANOMALIES WERE DETECTED BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED (21AT0SV STER. 2100238). A FINAL REPORT WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO DISASSEMBLY BETWEEN THE MOBILE LINER AND THE HUMERAL HEAD. BASED ON THE AVAILABLE INFORMATION, THE MOBILE LINER IS A LIMA DEVICE (CODE 5566.50.401, LOT 21AT0SV, STER. 2100238), WHILE THE HEAD IS FROM A DIFFERENT MANUFACTURER. IT WAS REPORTED THAT THE SAME ISSUE HAD ALREADY OCCURRED FOR THE SAME PATIENT, BUT NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2018, THE REVISION SURGERY ON (B)(6) 2023. PATIENT IS FEMALE, 77 YEARS OLD. THIS EVENT OCCURRED IN UK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167508 MOBILE LINER DIA.INT.28MM DIA.EXT.40MM MOBILE LINER DIA.INT.28MM DIA.EXT.40MM LZO LIMACORPORATE S.P.A. 5566.50.401 21AT0SV

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention