BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SIZE 54MM

    MDR report key: 3241423 · Received July 22, 2013

    Report

    Report Number
    0001825034-2013-02823
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2012
    Report Date
    September 18, 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
    TX, 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.¿

    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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02823 & 04508).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A RIGHT REVISION PROCEDURE OCCURRED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, LOSS OF MOBILITY AND INFLAMMATION. 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 INDICATE THAT THE REVISION PERFORMED ON (B)(6) 2012 WAS DUE TO PAIN WITH POSSIBLE HIP IMPINGEMENT AND SOME ANTERIOR OVERHANGING OF THE ACETABULAR CUP. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A RIGHT REVISION PROCEDURE OCCURRED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, LOSS OF MOBILITY AND INFLAMMATION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341519 M2A-MAGNUM MODULAR HEAD SIZE 54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 681530

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R