BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SIZE 56MM

    MDR report key: 3170951 · Received June 14, 2013

    Report

    Report Number
    0001825034-2013-01965
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    September 12, 2011
    Report Date
    April 3, 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
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, 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 BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01965 / 01966).

    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.

    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. THIS REPORT IS NUMBER 1 OF 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01965 / 01966 AND REFERENCE 1825034-2014-01190).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. HEAD WAS REMOVED AND REPLACED WITH BIOMET PRODUCT. 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 REPORTS THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. HEAD WAS REMOVED AND REPLACED WITH BIOMET PRODUCT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE NOTES INDICATE A CLEAR JOINT EFFUSION WAS FOUND DURING THE (B)(6) 2011 REVISION. NO EVIDENCE OF TISSUE NECROSIS OR PSEUDOTUMOR WAS FOUND. THE COMPONENTS WERE REPORTED TO BE WELL-FIXED WITH HYPO-ANTEVERSION OF THE ACETABULAR COMPONENT. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT MEDICAL RECORDS REPORTS PATIENT ALLEGED A POPPING SENSATION AS WELL AS RIGHT HIP PAIN WHILE SQUATTING AND PIVOTING FOLLOWING THE (B)(6) 2011 PROCEDURE. REVIEW OF INVOICE HISTORY CONFIRMS PATIENT WAS REVISED A SECOND TIME ON THE RIGHT SIDE ON (B)(6) 2013. THE HEAD WAS REMOVED AND REPLACED. MEDICAL RECORDS FURTHER INDICATE THAT PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY. THE DATE OF THE LEFT HIP ARTHROPLASTY AND INFORMATION REGARDING IMPLANTS WAS NOT PROVIDED. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THAT BIOMET COMPONENTS WERE IMPLANTED IN THE PATIENT'S LEFT HIP AND A REVISION PROCEDURE HAS WAS NOT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270411 M2A-MAGNUM MODULAR HEAD SIZE 56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 293030

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R