BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 42MM

    MDR report key: 3840600 · Received May 30, 2014

    Report

    Report Number
    0001825034-2014-05054
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    June 24, 2009
    Report Date
    July 8, 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
    CA, 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.¿ 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 1825034-2014-05054 & 05055).

    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.

    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 FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, INVOICE HISTORY INDICATES PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2009. THE REVISION INVOICE SUGGESTS ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD. 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 FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, INVOICE HISTORY INDICATES PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2009. THE REVISION INVOICE SUGGESTS ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE RIGHT HIP REVISION PROCEDURE PERFORMED ON (B)(6) 2009 WAS DUE TO CLICKING AND GRINDING. THE PATIENT'S OPERATIVE REPORT NOTED SCAR TISSUE, METALLOSIS, FIBROUS TISSUE, AND A CYST. 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
    319065 M2A-MAGNUM MOD HD SZ 42MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 575060

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R