BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 42MM HEAD DIAMETER

    MDR report key: 6135359 · Received November 30, 2016

    Report

    Report Number
    0001825034-2016-04908
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    December 15, 2014
    Report Date
    June 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCTS - TAPERLOC FEMORAL STEM CATALOG#: 11-103200 LOT#: 972060, M2A MAGNUM CUP CATALOG#: US157848 LOT#:756250, M2A MAGNUM TAPER ADAPTER CATALOG#: 139252, LOT#: 093790.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT HIP REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, AND PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE NOTES REPORTED IMAGING FINDINGS REVEAL SOFT TISSUE MASS AND FLUID ACCUMULATION. MODERATE METAL STAINED FIBROUS TISSUE HYPERTROPHY AROUND CIRCUMFERENCE OF ACETABULUM. APPROXIMATELY 60 CC OF CLEAR BROWNISH FLUID WAS DRAINED. RUBBERY, GRAY STAINED NODULAR TISSUE WAS THEN RESECTED FROM THE CIRCUMFERENCE AROUND THE ACETABULAR SHELL. THE ARTICULAR SURFACE OF THE ACETABULAR DEVICE LIKEWISE APPEARED TO BE ESSENTIALLY BRAND-NEW. THERE WAS NO EVIDENCE OF ANY IMPINGEMENT. THE BONE-METAL INTERFACE WAS DEMONSTRATED ALONG THE POSTERIOR LATERAL ARC OF IMPLANT AND EVIDENCED SOLID BONE INGROWTH. MULTIPLE RECORDS TAKEN BETWEEN INITIAL SURGERY AND REVISION SURGERY INDICATE ELEVATED BLOOD METAL ION LEVELS. LEVELS DECREASE SIGNIFICANTLY IN BLOOD SCREENING RECORD TAKEN AFTER REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO ELEVATED METAL ION LEVELS AND PAIN. DURING THE PROCEDURE, METAL STAINED FIBROUS TISSUE HYPERTROPHY, CLEAR BROWNISH FLUID AND A WELL-FIXED STEM AND CUP WERE NOTED. THE FEMORAL HEAD WAS REMOVED AND REPLACED, AND AN ACETABULAR LINER WAS ALSO IMPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787167 M2A MAGNUM MODULAR HEAD 42MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 207630

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R