BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RM52260149 DS10014928 BI MENTUM RK PE LINER 28 49

    MDR report key: 21230744 · Received January 24, 2025

    Report

    Report Number
    3008668801-2025-00081
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    August 9, 2023
    Report Date
    January 24, 2025
    Manufacturer
    S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
    Product Code
    MEH
    UDI-DI
    03662200015658
    PMA / PMN Number
    K181744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    (B)(4): SERF RC-23-0136 "PATIENT WAS REVISED DUE TO EARLY INFECTION. HEAD LINER EXCHANGED. NO ADDITIONAL INFORMATION IS AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630484 RM52260149 DS10014928 BI MENTUM RK PE LINER 28 49 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 2103646A 03662200015658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H