BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 3180718 · Received June 20, 2013

    Report

    Report Number
    0001825034-2013-02089
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 2, 2012
    Report Date
    May 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-01701-1 & 2013-02089).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION RECEIVED IN MEDICAL RECORDS AND BLOOD TEST RESULTS, WHICH WERE UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01701, 2013-02089, 04256 /04258).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2009 FOR UNKNOWN REASONS. AN ADDITIONAL REVISION PROCEDURE OCCURRED ON (B)(6)2012 DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED COCR LEVELS, TISSUE/BONE DESTRUCTION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2009, DUE TO ALLEGED ELEVATED METAL ION LEVELS AND TISSUE AND BONE DESTRUCTION. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2009 WAS DUE TO HETEROTOPIC BONE, CLEAR SYNOVIAL FLUID, IMPINGEMENT OF ILIOTIBIAL BAND ON PELVIS AND SPURS. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. MEDICAL RECORDS INDICATE PATIENT UNDERWENT A REVISION ON (B)(6) 2012 DUE TO BROWN SYNOVIAL FLUID AS A RESULT OF METAL ON METAL REACTION, ELEVATED METAL ION LEVELS, LEG LENGTH DISCREPANCY AND HETEROTOPIC OSSIFICATION. THE OPERATIVE NOTES CONFIRM THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR CUP AND A BIOMET MODULAR HEAD. A FURTHER REVISION OCCURRED ON (B)(6) 2012 DUE TO INSTABILITY. MEDICAL RECORDS NOTED ANTEVERSION ON THE STEM. THE BIOMET MODULAR HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280848 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 527080

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R