BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 3231025 · Received July 17, 2013

    Report

    Report Number
    0001825034-2013-02714
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    August 21, 2012
    Report Date
    February 9, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED AS IT IS UNKNOWN WHICH SIDE WAS REVISED ON GIVEN DATES. THE TWO PRODUCTS THAT WERE REVISED ARE AS FOLLOWS: DATE OF EVENT - (B)(6) 2012. DATE EXPLANTED - (B)(6) 2012. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02714 / 02715). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL REPORT. THIS REPORT IS NUMBER 1 OF 4 MDR'S FILED FOR THIS EVENT (REFERENCE 1825034-2013-02714 / 02715 & 2015-00745 / 00746). 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 ALLEGATIONS OF PAIN, DISCOMFORT, TISSUE/BONE DESTRUCTION AND ELEVATED METAL ION LEVELS. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURES OCCURRED ON RIGHT (B)(6) 2006 AND LEFT (B)(6) 2008. SUBSEQUENTLY, PATIENT ALLEGES BILATERAL REVISION PROCEDURES. A REVIEW OF INVOICE HISTORY CONFIRMS A REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2012 AND (B)(6) 2012 TO REMOVE AND REPLACE THE HEADS. IT IS UNKNOWN WHICH SIDE WAS REPLACED ON THOSE DATES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT ALLEGES BILATERAL REVISION PROCEDURES OCCURRED DUE TO PAIN, DISCOMFORT, TISSUE/BONE DESTRUCTION AND ELEVATED METAL ION LEVELS. INVOICE HISTORY CONFIRMS REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2012 TO REMOVE AND REPLACE THE MODULAR HEADS. IT IS UNKNOWN WHICH SIDE WAS REPLACED ON THOSE DATES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS INDICATES THE RIGHT HIP WAS REVISED ON (B)(6) 2012 DUE TO CHRONIC PAIN AND ELEVATED METAL ION LEVELS AND THE LEFT HIP WAS REVISED ON (B)(6) 2012 DUE TO PAIN, ELEVATED METAL ION LEVELS AND VERTICAL POSITIONING OF THE ACETABULAR CUP. THE RIGHT HIP REVISION OPERATIVE REPORT NOTES EVIDENCE OF METALLOSIS, DARK FLUID IN THE JOINT, BLACK STAINING THROUGHOUT THE SYNOVIUM, THE PRESENCE OF METAL DEBRIS, AND SUPEROLATERAL LOOSENING OF THE ACETABULAR CUP. THE LEFT HIP REVISION OPERATIVE REPORT NOTES WEAK AND MINIMAL BONE, LYTIC AREAS IN THE ACETABULUM, NECROSIS, A LARGE AMOUNT OF FLUID, AND THE PRESENCE OF METAL DEBRIS. DURING BOTH REVISION PROCEDURES, THE MODULAR HEADS AND ACETABULAR CUPS WERE REMOVED AND REPLACED WITH BIOMET MODULAR HEADS AND COMPETITOR ACETABULAR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331649 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 821990

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R