BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BI-MENTUM ACETABULAR CUP

    MDR report key: 21230593 · Received January 24, 2025

    Report

    Report Number
    3008668801-2025-00075
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    December 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: UNKNOWN BI-MENTUM ACETABULAR LINER; CAT# UNK_JSE; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    (B)(4): SERF RC-24-0259 (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR (B)(6) 2023 AND ENDING ON (B)(6) 2023. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: "INFECTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663268 UNKNOWN BI-MENTUM ACETABULAR CUP PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION UNKNOWN

    Patients

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