BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 3241194 · Received July 22, 2013

    Report

    Report Number
    0001825034-2013-02813
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    January 10, 2007
    Report Date
    January 24, 2014
    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 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-012812 / 02815).

    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. 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.¿ CORRECTED DATA: EVENT DATE - (B)(6) 2007; EXPLANT DATE - (B)(6) 2007. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02812-1/02815-1 AND 1825034-2014-00451/00454).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING.¿ AND ¿LOOSENING OR MIGRATION OF IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, METALLOSIS AND METAL POISONING. REVIEW OF INVOICE HISTORY INDICATES PATIENT WAS REVISED ON (B)(6) 2007 DUE TO BONE FRACTURE. A CABLE SYSTEM WAS IMPLANTED AND THE MODULAR HEAD, TAPER ADAPTER AND STEM WERE REMOVED AND REPLACED. LEGAL COUNSEL FOR PATIENT ALLEGES THE PATIENT WAS REVISED ON (B)(6) 2011. 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 REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE HISTORY CONFIRMS A REVISION PROCEDURE WAS PERFORMED (B)(6) 2011. THE CUP, HEAD, ADAPTER AND STEM WERE REMOVED AND REPLACED. 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 PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, METALLOSIS AND METAL POISONING. REVIEW OF INVOICE HISTORY INDICATES PATIENT WAS REVISED ON (B)(6) 2007 DUE TO BONE FRACTURE. A CABLE SYSTEM WAS IMPLANTED AND THE MODULAR HEAD, TAPER ADAPTER AND STEM WERE REMOVED AND REPLACED. LEGAL COUNSEL FOR PATIENT ALLEGES THE PATIENT WAS REVISED ON (B)(6) 2011. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S (B)(6) 2007 REVISION MEDICAL RECORDS NOTED THE REVISION WAS DUE TO A DISLOCATION AND THE STEM ROTATING. THE MODULAR HEAD, TAPER ADAPTER AND STEM WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341657 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 460540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R