BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RM52240049 DS4901149 BI MENTUM RK CEM CUP 49

    MDR report key: 21230742 · Received January 24, 2025

    Report

    Report Number
    3008668801-2025-00080
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    July 1, 2023
    Report Date
    January 24, 2025
    Manufacturer
    S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
    Product Code
    MEH
    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-23-0134 IT WAS REPORTED THAT THE IMPLANTS WERE EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630482 RM52240049 DS4901149 BI MENTUM RK CEM CUP 49 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 03662200015412 1907182A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R