BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX56MM

    MDR report key: 3800713 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03727
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 15, 2011
    Report Date
    July 21, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THESE TYPES OF EVENTS CAN OCCUR: NUMBER 6. INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS. AND, NUMBER 14. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01647 / 2014-03727).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, IT IS ALLEGED THAT PATIENT WAS REVISED ON (B)(6) 2011, FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION FROM PATIENT¿S LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN, SORENESS, DYSFUNCTION AND LOSS OF RANGE OF MOTION. PATIENT¿S LEGAL COUNSEL ALSO REPORTED THAT A LOOSE ACETABULAR COMPONENT WAS NOTED AT TIME OF REVISION SURGERY. 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) 2005. SUBSEQUENTLY, IT IS ALLEGED THAT PATIENT WAS REVISED ON (B)(6) 2011, FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION FROM PATIENT'S LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN, SORENESS, DYSFUNCTION AND LOSS OF RANGE OF MOTION. PATIENT'S LEGAL COUNSEL ALSO REPORTED THAT A LOOSE ACETABULAR COMPONENT WAS NOTED AT TIME OF REVISION SURGERY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT LEFT HIP REVISION PERFORMED ON MARCH 15, 2011 NOTED A LOOSE AND MIGRATED ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279557 M2A 1 PC SHELL 38MMX56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 927190

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R