BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA

    MDR report key: 22093980 · Received May 28, 2025

    Report

    Report Number
    3008021110-2025-00068
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 27, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBL
    UDI-DI
    08033390183970
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHECK OF DEVICE HISTORY RECORDS DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALIES ON THE INVOLVED LOT NUMBER 2082434. THIS IS THE FIRST AND ONLY COMPLAINT REPORTED REGARDING THE LOT NUMBER 2082434 INVOLVED. A FINAL MDR REPORT WILL BE SUBMITTED AT THE END OF THE INVESTIGATION.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT OF THE RIGHT HIP ARTHROPROSTHESIS. LIMACORPORATE FEM. MODULAR HEAD - S Ø28MM (PRODUCT CODE: 5010.42.281 - LOT. 2082434 - STER. (B)(4)) WAS EXPLANTED, TOGETHER WITH DEDIENNE LEGAL MANUFACTURER DEVICES ACET.CUP CEMENTED SZ.48MM / SYMBOL (PRODUCT CODE: 3700502203660 - LOT. 204780040A) AND PE-INSERT 28MM (PRODUCT CODE: 3700502203875 - LOT: 204482040A). PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021. PATIENT 88 YEARS OLD. EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328433 BIOLOX DELTA BIOLOX DELTA - FEMORAL HEAD DIA 28 MM #S MBL LIMACORPORATE S.P.A. 5010.42.281 2082434 08033390183970

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention