BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 23692504 · Received December 2, 2025

    Report

    Report Number
    3008021110-2025-00158
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    October 24, 2025
    Report Date
    November 27, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBL
    UDI-DI
    08033390298100
    PMA / PMN Number
    K1413274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHECK OF DEVICE HISTORY RECORDS (DHRS) DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALIES ON THE LOT NUMBERS INVOLVED. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ABOUT THESE LOT NUMBERS. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    COMPLAINT SOURCE REPORTED REVISION DUE TO INFECTION PERFORMED ON (B)(6) 2025. PREVIOUS SURGERY PERFORMED ON (B)(6) 2015. PATIENT 49 YEARS OLD. THE DEVICES EXPLANTED ARE THE FOLLOWING: · DELTA PROTR.LINER ØINT 32MM #M (PRODUCT CODE: 588651158, LOT: 1509428 - STER: (B)(4) - SOLD IN US. · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE: 8420.15.020, LOT: 1507404 - STER: (B)(4)) - SOLD IN US. · SAM-FIT RIGHT MOD.FEM. STEM #1 (PRODUCT CODE: 4216.25.110, LOT: 1103050 - STER: (B)(4)) - NOT SOLD IN US. · MODULAR NECK STD-S (S1) (PRODUCT CODE: 4220.09.110, LOT: 1512295 - STER: (B)(4)) - NOT SOLD IN US. · FEM. MODULAR HEAD - S Ø32MM (PRODUCT CODE: 5010.42.321, LOT: 1482052 - STER: (B)(4)) - SOLD IN US. · DELTA-PF ACETAB.CUP Ø50 MM (PRODUCT CODE: 5551.25.500, LOT: 1500348 - STER: (B)(4)) - NOT SOLD IN US. · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE: 8420.15.010, LOT: 1507399 - STER: (B)(4)) - SOLD IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900431 FEMORAL HEAD FEMORAL HEAD - DIA.32MM SHORT TAPER 12/14 MBL LIMACORPORATE S.P.A. 5010.42.321 1482052 08033390298100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention