BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 3902878 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05832
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 22, 2014
    Report Date
    December 23, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    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. 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." 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 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05832 AND 07153 / 07155).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE OCCURRED ON (B)(6) 2014 DUE TO PAIN. THE HEAD AND STEM WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE OCCURRED ON (B)(6) 2014 DUE TO PAIN. THE HEAD AND STEM WERE REMOVED AND REPLACED. LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, SORENESS, DECREASED RANGE OF MOTION, DIFFICULTY WALKING AND BENDING, DEVICE FRETTING/CORROSION AND DAMAGED TISSUE. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE OCCURRED ON (B)(6) 2014 DUE TO PAIN. THE HEAD AND STEM WERE REMOVED AND REPLACED. LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, SORENESS, DECREASED RANGE OF MOTION, DIFFICULTY WALKING AND BENDING, DEVICE FRETTING/CORROSION CAUSING METALS TO BE RELEASED IN BODILY TISSUE, AND DAMAGED TISSUE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED THE (B)(6) 2014 REVISION WAS DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED SCAR TISSUE, FLUID, AND A LOOSE STEM. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED PATIENT'S BLOOD WAS TESTED ON (B)(6) 2014. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379368 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 141530

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R