BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD+6MM NK NO SKRT

    MDR report key: 3112442 · Received May 14, 2013

    Report

    Report Number
    0001825034-2013-01500
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 18, 2011
    Report Date
    April 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT IDENTIFICATION, DATES OF REVISION PROCEDURES AND THE REASONS FOR THE REVISION PROCEDURES, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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. PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID. IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." THIS REPORT IS NUMBER 1 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01500 / 01501 & 03023/3026).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. BRAND NAME - UNKNOWN. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. DATE EXPLANTED - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-01500 / 1501). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES AND REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, INFLAMMATION, DYSFUNCTION AND LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS BOTH PRIMARY SURGERY DATES. ADDITIONAL INFORMATION ALSO INDICATES THAT THE RIGHT HIP WAS REVISED ON (B)(6) 2011 DUE TO OSTEOLYSIS, METALLOSIS AND A FRACTURED SCREW. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, SCREW AND MODULAR HEAD WERE REMOVED AND REPLACED. THE LEFT HIP WAS REVISED ON (B)(6) 2012 WHERE METALLOSIS IN THE PSEUDOCAPSULE WAS NOTED. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, SCREW AND MODULAR HEAD WERE REMOVED AND REPLACED. AN ADDITIONAL REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2013 WAS CONFIRMED DURING THE REVIEW OF INVOICE HISTORY. THE REASON FOR THAT REVISION PROCEDURE IS UNKNOWN AND NO INFORMATION HAS BEEN PROVIDED TO CONFIRM WHICH HIP WAS REVISED ON THAT DATE. 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 THE PATIENT REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES WITH THE LEFT SIDE ON (B)(6) 2006 AND THE RIGHT SIDE (B)(6) 2012. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, INFLAMMATION, DYSFUNCTION AND LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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
    212640 M2A 38MM MOD HD+6MM NK NO SKRT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 568310

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization