BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3803181 · Received May 9, 2014

    Report

    Report Number
    0001825034-2014-03758
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 12, 2013
    Report Date
    June 17, 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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." 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 3 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03765, 03757/03759, 03808, 03809 & 03814).

    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 A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, LACK OF MOBILITY, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND SUGGESTS PATIENT UNDERWENT A REVISION PROCEDURE OF THE LEFT HIP ON (B)(6) 2013. IT FURTHER SUGGESTS THAT PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2013 DUE TO ALLEGED INFECTION; THERE IS NO INDICATION AS TO WHICH HIP UNDERWENT THIS PROCEDURE. 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 A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, LACK OF MOBILITY, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND SUGGESTS PATIENT UNDERWENT A REVISION PROCEDURE OF THE LEFT HIP ON (B)(6) 2013. IT FURTHER SUGGESTS THAT PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2013 DUE TO ALLEGED INFECTION; THERE IS NO INDICATION AS TO WHICH HIP UNDERWENT THIS PROCEDURE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PAIN, LOOSENING AND CHRONIC INFECTION. THE PATIENT'S OPERATIVE REPORT NOTED MURKY, YELLOW FLUID; BONE LOSS; AND CHRONIC INFECTION. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PAIN AND CHRONIC INFECTION. THE PATIENT'S OPERATIVE REPORT NOTED A SUPERFICIAL ABSCESS, FLUID, AND CHRONIC INFECTION. 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
    281699 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 556510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R