BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD

    MDR report key: 8859022 · Received August 5, 2019

    Report

    Report Number
    3008021110-2019-00091
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 5, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE LOT# INVOLVED, NO ANOMALY WAS FOUND ON A TOTAL OF: (B)(4) FEM. MODULAR HEAD MANUFACTURED AND STERILIZED WITH LOT #1880271 STER.1800086; (B)(4) DELTA PROTR.LINER MANUFACTURED AND STERILIZED WITH LOT #1606735 STER.1600166. BY THE ANALYSIS, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET WITH THE SAME LOT#S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION OCCURRED ON (B)(6) 2019. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 AND WAS DUE TO FRACTURE OF THE FEMORAL NECK. DURING REVISON, THE FOLLOWING COMPONENTS WERE EXPLANTED: FEM. MODULAR HEAD - L Ø36MM, COD. 5010.42.363, LOT #1880271. DELTA PROTR.LINER ØINT 36MM #L, COD. 5886.51.260, LOT #1606735. PL3 HIP - STEM #5 H=153MM, NOT MARKED IN USA. DELTA-PF ACETAB.CUP Ø54 MM, NOT MARKED IN USA. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652572 FEM. MODULAR HEAD FEM. MODULAR HEAD (LZO JDI KWY KWZ LPH MBL) LZO LIMACORPORATE SPA 5010.42.363 1880271

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention