BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD STD NECK

    MDR report key: 2477787 · Received March 5, 2012

    Report

    Report Number
    0001825034-2012-00219
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    November 11, 2011
    Report Date
    March 21, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - UNKNOWN. EXPLANTED DATE - UNKNOWN. THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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. BIOMET PACKAGE INSERT CONTAINS THE FOLLOWING POSSIBLE ADVERSE EFFECTS: #1) MATERIAL SENSITIVITY REACTIONS. THIS REPORT IS NUMBER 5 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00215 THRU 0000220).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. RELEVANT TEST ¿ CHROMIUM LEVEL WAS 16.1PPB.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT REVISION PROCEDURES WERE PERFORMED ON UNKNOWN DATES DUE TO PATIENT ALLEGATIONS OF SWELLING AND INCREASED METAL ION LEVELS. ADDITIONAL INFORMATION RECEIVED INDICATES THAT PATIENT IS ENROLLED IN A CLINICAL STUDY. DURING POST OPERATIVE MONITORING AND TESTING, ELEVATED METAL IONS WERE NOTED. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PAIN, ELEVATED METAL ION LEVELS AND PSEUDOTUMOR. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, PATIENT EXPERIENCED SWELLING AND INCREASED BLOOD LEVELS AND WAS REVISED ON AN UNKNOWN DATE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT REVISION PROCEDURES WERE PERFORMED ON UNKNOWN DATES DUE TO PATIENT ALLEGATIONS OF SWELLING AND INCREASED METAL ION LEVELS. ADDITIONAL INFORMATION RECEIVED INDICATES THAT PATIENT IS ENROLLED IN A CLINICAL STUDY. DURING POST OPERATIVE MONITORING AND TESTING, ELEVATED METAL IONS AND PSEUDOTUMOR WERE NOTED. A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 AND A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM MODULAR HEAD STD NECK PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 006280

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R