BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-MENTUM REVISION CUP 55

    MDR report key: 21230320 · Received January 24, 2025

    Report

    Report Number
    3008668801-2025-00062
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    October 28, 2024
    Report Date
    March 2, 2026
    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
    SZ
    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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: DS10005528 - BI MENTUM R PE LINER 5528; CAT# RM52160155; LOT# 2306814A IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    UPDATE OF THE PRODUCT CATALOG IN SECTION D4. UPDATE IN SECTION G4 COMBINATION PRODUCT TO "NO". REPORTED EVENT: AN EVENT REGARDING PAIN (LEADING TO REVISION) INVOLVING A BI MENTUM R REVISION CUP 55 WAS REPORTED. SINCE THE DEVICES WERE NOT RETURNED TO SERF, A TECHNICAL INVESTIGATION IS NOT FEASIBLE. THE INVESTIGATION IS THEREFORE CONDUCTED BASED ON THE RECORDS AVAILABLE FOR THE AFFECTED BATCHES AND THE MONITORING RECORDS FOR THE PRODUCTION PERIOD OF THE AFFECTED BATCHES. THE DATA RECORDED BY SERF THROUGHOUT THE MANUFACTURING OF THE AFFECTED BATCHES, THE MICROBIOLOGICAL MONITORING DATA, AND THE PROCESS MONITORING DATA DEMONSTRATE THAT THE PRODUCTS WERE CLEAN AND STERILE WHEN THEY WERE PLACED ON THE MARKET. FURTHERMORE, THE INSPECTIONS PERFORMED DURING AND AT THE END OF PRODUCTION DEMONSTRATE THE DIMENSIONAL CONFORMITY OF THE PRODUCTS. THUS, THE SERF DEVICES WERE COMPLIANT WHEN THEY WERE PLACED ON THE MARKET. THE DATA RECORDED BY SERF THROUGHOUT THE MANUFACTURING OF THE AFFECTED BATCHES, THE MICROBIOLOGICAL MONITORING DATA, AND THE PROCESS MONITORING DATA DEMONSTRATE THAT THE PRODUCTS WERE CLEAN AND STERILE WHEN THEY WERE PLACED ON THE MARKET. FURTHERMORE, THE INSPECTIONS PERFORMED DURING AND AT THE END OF PRODUCTION DEMONSTRATE THE DIMENSIONAL CONFORMITY OF THE PRODUCTS. THUS, THE SERF DEVICES WERE COMPLIANT WHEN THEY WERE PLACED ON THE MARKET. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED.

    Description of Event or Problem · 0

    (B)(4): SERF RC-24-0383 REVISION HIP LEFT.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617656 BI-MENTUM REVISION CUP 55 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 2210381A

    Patients

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