BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 46MM

    MDR report key: 3090339 · Received May 2, 2013

    Report

    Report Number
    0001825034-2013-01216
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    June 16, 2010
    Report Date
    February 20, 2015
    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

    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: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "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 4 OF 8 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01213 / 01220).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A BILATERAL REVISION OCCURRED DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL LEVELS, METALLOSIS AND PAIN. LEGAL COUNSEL FOR PATIENT ALSO ALLEGED THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2011; HOWEVER, IT IS UNKNOWN IF ONE OR BOTH HIPS WERE REVISED. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH PRIMARY SURGERY DATES AND THAT THE BILATERAL REVISION TOOK PLACE ON (B)(6) 2010 TO REMOVE AND REPLACE THE MODULAR HEADS IN BOTH HIPS. THE PROCEDURE THAT ALLEGEDLY TOOK PLACE ON (B)(6) 2011 COULD NOT BE CONFIRMED THROUGH REVIEW OF INVOICE HISTORY. 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 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A BILATERAL REVISION OCCURRED DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL LEVELS, METALLOSIS AND PAIN. LEGAL COUNSEL FOR PATIENT ALSO ALLEGED THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2011; HOWEVER, IT IS UNKNOWN IF ONE OR BOTH HIPS WERE REVISED. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH PRIMARY SURGERY DATES AND THAT THE BILATERAL REVISION TOOK PLACE ON (B)(6) 2010 TO REMOVE AND REPLACE THE MODULAR HEADS IN BOTH HIPS. THE PROCEDURE THAT ALLEGEDLY TOOK PLACE ON (B)(6) 2011 COULD NOT BE CONFIRMED THROUGH REVIEW OF INVOICE HISTORY. ADDITIONAL INFORMATION RECEIVED FROM OPERATIVE REPORT NOTED PATIENT UNDERWENT A BILATERAL REVISION PROCEDURE ON (B)(6) 2010 DUE TO PAIN, METALLOSIS AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT FURTHER NOTED FLUID, A CLEAR HIP EFFUSION, METAL STAINED TISSUE IN THE RIGHT HIP. SCARRING AND FLUID WERE NOTED IN THE LEFT HIP DURING THE REVISION PROCEDURE. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED AND A COMPETITOR LINER WAS IMPLANTED IN BOTH HIPS. OPERATIVE REPORT NOTED PATIENT UNDERWENT A FURTHER LEFT HIP REVISION PROCEDURE ON (B)(6) 2011 DUE TO PAIN. OPERATIVE REPORT FURTHER NOTED FIBROUS INGROWTH BUT NO BONY INGROWTH AROUND THE ACETABULAR CUP DURING THE REVISION PROCEDURE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF铠COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191595 M2A-MAGNUM MODULAR HEAD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 843400

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R