BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -6MM NK

    MDR report key: 3181978 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02096
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 17, 2012
    Report Date
    November 17, 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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: ¿ FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN COMPONENTS.¿

    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." AND NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 2 OF 8 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02095 / 02102). 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 THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES AND REPORTS PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, COMPLICATIONS WITH HER RIGHT HIP, DIFFICULTY AMBULATING AND PROBLEMS SITTING, STANDING AND MOVING UP AND DOWN STAIRS, METALLOSIS, LOSS OF MOBILITY, LOSS OF RANGE OF MOTION AND PSEUDOTUMOR. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURES OCCURRED ON LEFT SIDE ON (B)(6) 2002 AND ON RIGHT SIDE ON (B)(6) 2003. FURTHER REVIEW CONFIRMS REVISION PROCEDURES WERE PERFORMED ON RIGHT SIDE ON (B)(6) 2012 AND (B)(6) 2012. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INITIAL RIGHT TOTAL ARTHROPLASTY WAS PERFORMED ON (B)(6) 2003. THE OPERATIVE REPORT INDICATES THAT THE (B)(6) 2012 RIGHT HIP REVISION WAS DUE TO PAIN AND METALLOSIS. THE OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF MILKY APPEARING FLUID CONSISTENT WITH ALVAL, A THICKENED PSEUDOCAPSULE, BURNISHING PRESENT ON THE HEAD AND CORROSION AT THE TAPER ADAPTER JUNCTION. THE MODULAR HEAD WAS REMOVED AND REPLACED. PATIENT'S MEDICAL RECORDS INDICATE THAT THE ACETABULAR CUP WAS REMOVED AND REPLACED DURING THE (B)(6) 2012 REVISION.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES AND REPORTS PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, COMPLICATIONS WITH HER RIGHT HIP, DIFFICULTY AMBULATING AND PROBLEMS SITTING, STANDING AND MOVING UP AND DOWN STAIRS, METALLOSIS, LOSS OF MOBILITY, LOSS OF RANGE OF MOTION AND PSEUDOTUMOR. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURES OCCURRED ON LEFT SIDE ON (B)(6) 2002 AND ON RIGHT SIDE ON (B)(6) 2003. FURTHER REVIEW CONFIRMS REVISION PROCEDURES WERE PERFORMED ON RIGHT SIDE ON (B)(6) 2012. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282137 M2A 38MM MOD HD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 961660

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R