BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-MENTUM PE LINER 28/53

    MDR report key: 21230738 · Received January 24, 2025

    Report

    Report Number
    3008668801-2025-00077
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    July 26, 2023
    Report Date
    February 4, 2026
    Manufacturer
    S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
    Product Code
    MEH
    UDI-DI
    03662200015511
    PMA / PMN Number
    K181744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION : AN EVENT REGARDING INFECTION (LEADING TO REVISION) INVOLVING A BI MENTUM RK PE LINER 28 53 WAS REPORTED. THE REPORTED DEVICE IS A SERF PRODUCT. THE PRODUCTS WERE NOT RETURNED, NO PRODUCT FOR INVESTIGATION CAN BE PERFORMED. NO X RAY HAS BEEN PROVIDED, NO INFORMATION. ALL BATCHES ARE RELEASED IN COMPLIANCE WITH SERF SPECIFICATIONS. SERF HAS NO EVIDENCE TO DETERMINE THE CAUSE OF THE COMPLAINT. REVISION LEADING TO IMPLANT REPLACEMENT CAN BE CAUSED BY SEVERAL FACTORS THAT CANNOT BE DEMONSTRATED DUE TO LACK OF INFORMATION. SERF DEVICES INVOLVEMENT IS UNLIKELY IN THESE CASES. THE CAUSE OF THE PROBLEM CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    (B)(4): (B)(6) PATIENT WAS REVISED DUE TO INFECTION.

    Description of Event or Problem · 0

    NO NEW INFORMATION. ON (B)(4): SERF RC-23-0124 PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630478 BI-MENTUM PE LINER 28/53 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 2009434A 03662200015511

    Patients

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