BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 42MM

    MDR report key: 3813164 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04161
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    October 3, 2007
    Report Date
    August 26, 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
    AL, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "MATERIAL SENSITIVITY REACTIONS.¿ AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." AND "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." 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 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04161/-04162/-04163/-04164).

    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. THIS REPORT IS NUMBER 1 OF 5 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04161/-04162/-04163/-04164 /-07608).

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, THE LEFT HIP WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, DISLOCATIONS, METALLOSIS AND ELEVATED METAL ION LEVELS. NO REVISION SURGERY HAS BEEN REPORTED FOR THE RIGHT HIP. 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 REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, THE LEFT HIP WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, DISLOCATIONS, METALLOSIS AND ELEVATED METAL ION LEVELS. NO REVISION SURGERY HAS BEEN REPORTED FOR THE RIGHT HIP. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2007 DUE TO PAIN AND A CLUNKING SENSATION. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF CLEAR STRAW-COLORED FLUID AND AN OSTEOPHYTE CREATING AN IMPINGEMENT. THE STEM AND ACETABULAR CUP WERE WELL FIXED. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. OPERATIVE REPORT PATIENT UNDERWENT AN ADDITIONAL LEFT HIP REVISION ON (B)(6) 2013 DUE TO PAIN. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF MILKY FLUID CONSISTENT WITH METALLOSIS, BLACKENED TISSUE, BONE LOSS, AND CYSTS. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR'S ACETABULAR SYSTEM AND A BIOMET HEAD. OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014 DUE TO METAL-ON-METAL WEAR. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF DARK TISSUE AND WEAR DEBRIS. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290919 M2A-MAGNUM MOD HD SZ 42MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 021470

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R