BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50M TAPER INSERT +3

    MDR report key: 3140339 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01752
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    January 24, 2012
    Report Date
    September 21, 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
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. 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, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00611 AND 01742 & 01752).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, ALTERED GAIT, CLICKING, TENDERNESS, LIMITED RANGE OF MOTION AND LOOSE FEMORAL STEM. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE REVISION OPERATIVE NOTES INDICATES THAT THE REVISION PROCEDURE PERFORMED (B)(6) 2012 WAS DUE TO PAIN AND A LOOSE FEMORAL STEM. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012, DUE TO PATIENT ALLEGED PAIN, ALTERED GAIT, CLICKING, TENDERNESS, DAMAGE TO SURROUNDING BONE AND TISSUE AND LIMITED RANGE OF MOTION. PATIENT'S LEGAL COMPLAINT ALSO ALLEGES THE STEM WAS LOOSE DURING THE REVISION. 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
    241517 M2A-MAGNUM 42-50M TAPER INSERT +3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 893940

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R