BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 2810106 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02301
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 9, 2010
    Report Date
    April 23, 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DATE OF EVENT - (B)(6) 2010. DATE EXPLANTED - (B)(6) 2010. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. 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." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 5 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2012-02298 / 02303).

    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.

    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." THIS REPORT IS NUMBER 4 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2012-02298 / 02303).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY. THE RIGHT HIP PROCEDURE OCCURRED ON (B)(6) 2006, AND THE LEFT PROCEDURE OCCURRED ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, INFLAMMATION, AND PSEUDOTUMORS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. 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 BILATERAL TOTAL HIP ARTHROPLASTY. THE RIGHT HIP PROCEDURE OCCURRED ON (B)(6) 2006, AND THE LEFT PROCEDURE OCCURRED ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DESTRUCTION, METAL POISONING, METALLOSIS, ELEVATED COBALT CHROMIUM LEVELS, LOSS OF RANGE OF MOTION, INFLAMMATION, AND PSEUDOTUMORS. PATIENT ALLEGES REVISION PROCEDURES OCCURRED ON (B)(6) 2010 AND (B)(6) 2010. A REVIEW OF INVOICE HISTORY CONFIRMS THE (B)(6) 2010 REVISION PROCEDURE AND THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S OPERATIVE (OP) NOTES REPORTS A RIGHT HIP REVISION OCCURRED ON (B)(6) 2010 DUE TO PSEUDOTUMOR FORMATION AND LYSIS OF THE FEMORAL COMPONENT. THE MODULAR HEAD, ACETABULAR CUP, AND TAPER ADAPTER WERE REMOVED AND REPLACED. THE STEM WAS REMOVED AND REPLACED WITH A COMPETITOR PRODUCT. REVISION OP NOTES ALSO REPORT A LEFT HIP REVISION OCCURRED (B)(6) 2010. DURING THE LEFT REVISION, OP REPORT NOTES THE PRESENCE OF MATERIAL DEBRIS; REACTIVE EFFUSION; AND INDURATED, INFLAMED, AND REACTIVE SYNOVIAL AND CAPSULAR TISSUE. THE HEAD, CUP, TAPER ADAPTER, AND STEM WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS..

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY. THE RIGHT HIP PROCEDURE OCCURRED ON (B)(6) 2006, AND THE LEFT PROCEDURE OCCURRED ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DESTRUCTION, METAL POISONING, METALLOSIS, ELEVATED COCR LEVELS, LOSS OF RANGE OF MOTION, INFLAMMATION, AND PSEUDOTUMORS. PATIENT ALLEGES REVISION PROCEDURES OCCURRED ON (B)(6) 2010 AND (B)(6) 2010. A REVIEW OF INVOICE HISTORY CONFIRMS THE (B)(6) 2010 REVISION PROCEDURE AND THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. IT IS NOT KNOWN WHICH SIDE WAS REVISED ON THESE DATES. 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
    1 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 818880

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention| S