BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BI-MENTUM HIP ACETABULAR LINER

    MDR report key: 21224801 · Received January 23, 2025

    Report

    Report Number
    3008668801-2025-00017
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    March 9, 2023
    Report Date
    January 23, 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.

    Description of Event or Problem · 0

    (B)(4): SERF RC-23-0164 THE LITERATURE ARTICLE ¿POSTERIOR APPROACH TOTAL HIP ARTHROPLASTY UTILIZING A MONOBLOCK DUAL- MOBILITY CONSTRUCT WITHOUT POSTERIOR HIP PRECAUTIONS: A SERIOUS OF 580 HIPS WITH ONE DISLOCATION¿ BY JOSEPH T GIBIAN, MD, THOMAS S. HONG, MD AND RYAN NUNLEY, MD ACCEPTED TO BE PUBLISHED ON 9 MAR 2023 WAS REVIEWED BY A CLINICIAN FOR ADVERSE EVENTS. THE PURPOSE OF THE STUDY WAS TO DESCRIBE A MINI-POSTERIOR APPROACH WITH A MONOBLOCK DUAL-MOBILITY IMPLANT WITHOUT ¿TRADITIONAL POSTERIOR HIP PRECAUTIONS.¿ ALL PATIENTS RECEIVED A MONOBLOCK PRESS-FIT BI-MENTUM ACETABULAR COMPONENT AND POLYETHYLENE LINER (DEPUY SYNTHES, RAYNHAM, MA) AND A BIOLOX DELTA CERAMIC HEAD (EXATECH, GAINESVILLE, FL). FEMORAL COMPONENTS WERE THE ACTIS TRIPLED TAPERED STEM (DEPUY SYNTHES,RAYNHAM, MA) IN 555 HIPS, THE EMPHASYS DUAL TAPERED STEM (DEPUY SYNTHES,RAYNHAM, MA) IN 12 HIPS, AND IN 3 OR FEWER HIPS EACH: THE WAGNER CYLINDRICAL SPLINED STEM (COMPETITOR), CORAIL (DEPUY SYNTHES), RECLAIM (DEPUY SYNTHES, RAYNHAM, MA), AND SUMMIT (DEPUY SYNTHES, RAYNHAM, MA) IN PATIENTS WHO HAVE ABNORMAL PREOPERATIVE FEMORAL ANATOMY. THE FOLLOWING ADVERSE EVENTS WERE IDENTIFIED: SEVEN PATIENTS REQUIRED REOPERATIONS: ONE DISLOCATION, FOUR PERIPROSTHETIC FEMUR FRACTURES, AND TWO PROSTHETIC JOINT INFECTIONS. THE ONLY PATIENT WHO SUSTAINED A DISLOCATION WAS A 64-YEAR-OLD MAN WHO HAD A HISTORY OF MULTIPLE CERVICAL SPINAL PROCEDURES WITH BILATERAL LOWER EXTREMITY WEAKNESS. HE PRESENTED ON POSTOPERATIVE DAY 54 WITH A DISLOCATION WHICH OCCURRED WHILE BEING AGGRESSIVELY TRANSFERRED IN HIS BED AT HIS FACILITY. DURING ATTEMPTED CLOSED REDUCTION IN THE OPERATING ROOM, THE DUAL-MOBILITY CONSTRUCT DISSOCIATED. WHILE PREPARING FOR AN OPEN PROCEDURE, THE PATIENT DECOMPENSATED, AND THE PROCEDURE WAS ABORTED. SUCCESSFUL OPEN REDUCTION WAS ACHIEVED TWO DAYS LATER. THE HIP WAS STABLE AT THE END OF THE PROCEDURE. THE PATIENT FELL SIX WEEKS AFTER THIS REVISION PROCEDURE AND SUSTAINED A SECOND DISLOCATION EVENT. HE UNDERWENT OPEN REDUCTION AFTER FAILED CLOSED REDUCTION. AT HIS TWO-YEAR POSTOPERATIVE VISIT, HE REPORTED THAT HE WAS DOING WELL WITHOUT ANY ADDITIONAL EPISODES OF DISLOCATION. THIS PI IS FOR THE SECOND DISLOCATION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669278 UNKNOWN BI-MENTUM HIP ACETABULAR LINER 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 Hospitalization| R