BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-MENTUM PLUS CUP 53

    MDR report key: 21230739 · Received January 24, 2025

    Report

    Report Number
    3008668801-2025-00076
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    August 21, 2024
    Report Date
    February 25, 2026
    Manufacturer
    S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
    Product Code
    MEH
    UDI-DI
    03662200015153
    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

    REPORTED EVENT: AN EVENT REGARDING INFECTION (LEADING TO REVISION) INVOLVING A BI MENTUM RK PLUS CUP 53 WAS REPORTED. INVESTIGATION CONCLUSIONS: BI-MENTUM PLUS CUP 53 -> LOT - BATCH N° 1902177A. MANUFACTURING ORDER (B)(4) UNITS. WEEK: 16 / 17 CLEANING DATE: 16.04.2019. PACKAGING: 16.04.2019. STERILIZATION DATE: 22.04.2019 ¿ ORDER (B)(4). TECHNICAL INVESTIGATION: SINCE THE DEVICES HAVE NOT BEEN RETURNED TO SERF, A TECHNICAL INVESTIGATION IS NOT FEASIBLE. THE INVESTIGATION WILL THEREFORE BE CONDUCTED BASED ON THE RECORDS AVAILABLE FOR THE BATCHES CONCERNED AND THE MONITORING RECORDS OVER THE PRODUCTION PERIOD OF THE BATCHES CONCERNED. DOCUMENTARY INVESTIGATION: FOR THE BATCHES OF DEVICES, THE FINAL CLEANING ENSURING DECONTAMINATION DOES NOT PRESENT ANY ANOMALY. THIS IS COMPLIANT WITH THE VALIDATED CYCLE. ¿ BATCH 1902177A: PROGRAM 2 METAL CARRIED OUT ON 16/04/2019. COMPLIANT PARAMETERS. FOR THE BATCHES 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 1902177A: HEAT SEALING ¿120¿ CARRIED OUT ON 16/04/2019. COMPLIANT PARAMETERS. FOR THE BATCHES OF DEVICES, THE STERILIZATION STEP DOES NOT PRESENT ANY ANOMALY. THE RESULTS ARE IN LINE WITH EXPECTATIONS. ¿ BATCH 1902177A: ORDER=(B)(4) OF 19/04/2019. TREATMENT (B)(6) OF 22/04/2019. COMPLIANT PARAMETERS. OVERALL CONCLUSION: THE MANUFACTURING STEPS ENSURING THE CLEANLINESS AND STERILITY OF THE DEVICES DO NOT PRESENT ANY DEVIATIONS LIKELY TO COMPROMISE THE CLEANLINESS OR STERILITY OF THE PRODUCTS.

    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: RM52280065 DS50001565 BI MENTUM RK SCREW 5 65; CAT# RM52280065; LOT# 1808124A. RM52260153 DS10015328 BI MENTUM RK PE LINER 28 53; CAT# RM52260153; LOT# 1909319A. 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

    NO NEW INFORMATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610713 BI-MENTUM PLUS CUP 53 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC MEH S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 1902177A 03662200015153

    Patients

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