BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-MENTUM PE LINER 28/49

    MDR report key: 21980546 · Received May 7, 2025

    Report

    Report Number
    3008668801-2025-00115
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 10, 2025
    Report Date
    March 10, 2026
    Manufacturer
    S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
    Product Code
    LZO
    PMA / PMN Number
    K181744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATE OF CATALAG NUMBER IN SECTION D4. REPORTED EVENT: AN EVENT REGARDING INFECTION (LEADING TO REVISION) INVOLVING A BI-MENTUM PFR PE LINER 4928 WAS REPORTED. THE REPORTED DEVICE IS AN SERF PRODUCT. INVESTIGATION CONCLUSION: SINCE THE DEVICES WERE NOT RETURNED TO SERF, A TECHNICAL INVESTIGATION IS NOT FEASIBLE. THE INVESTIGATION IS THEREFORE CONDUCTED USING THE AVAILABLE RECORDS FOR THE AFFECTED BATCHES AND THE MONITORING RECORDS FROM THE PRODUCTION PERIOD OF THE AFFECTED BATCHES. AN INVESTIGATION FOCUSED ON THE STEPS THAT COULD IMPACT THE CLEANLINESS AND STERILITY OF THE PRODUCTS WAS CONDUCTED. 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. THEREFORE, THE SERF DEVICES CANNOT BE THE SOURCE OF THE INFECTION THAT OCCURRED. BI-MENTUM PE LINER 28/49 LOT - N°2309352A. MANUFACTURING ORDER (B)(4) / (B)(4) UNITS. CLEANING DATE: (B)(6) 2024. PACKAGING: 21/03/2024. STERILIZATION DATE: (B)(6) 2024 - ORDER (B)(4). FOR THE BATCH OF DEVICES, THE FINAL CLEANING ENSURING DECONTAMINATION DOES NOT PRESENT ANY ANOMALY. THIS IS COMPLIANT WITH THE VALIDATED CYCLE. BATCH 2309352A: CYCLES 22133, 22134 AND 22135 ¿ PROGRAM ¿PLASTIC - 1¿ CARRIED OUT ON 21/03/2024. COMPLIANT PARAMETERS. FOR THE BATCH OF DEVICES, THE PRIMARY PACKAGING ENSURING THE MAINTENANCE OF THE STERILE STATE AFTER STERILIZATION DOES NOT PRESENT ANY ANOMALY. THIS IS COMPLIANT WITH THE VALIDATED CYCLES. BATCH 2309352A: VACUUM ¿PROG 1PA/PE¿ CARRIED OUT ON 21/03/2024. COMPLIANT PARAMETERS. BATCH 2309352A: HEAT SEALING ¿110¿ CARRIED OUT ON 21/03/2024. COMPLIANT PARAMETERS. FOR THE BATCH OF DEVICES, THE STERILIZATION STEP DOES NOT PRESENT ANY ANOMALY. THE RESULTS ARE IN LINE WITH EXPECTATIONS. BATCH 2309352A: ORDER=(B)(4) OF 22/03/2024. TREATMENT (B)(4) DU (B)(6) 2024. COMPLIANT PARAMETERS. CONCLUSION: NONE NON-CONFORMITY OR REWORK PERFORMED TO THE BATCH THEREFORE THE CONFORMITY OF THE RELEASED PRODUCTS IS NOT CALLED INTO QUESTION. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED.

    Description of Event or Problem · 0

    PATIENT OCCURED A POSTOPERATIVE INFECTION AND INFLAMMATION. ALL IMPLANTS WAS REVISED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140070 BI-MENTUM PE LINER 28/49 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 2309352A

    Patients

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