BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B STD 60MM

    MDR report key: 3979463 · Received August 5, 2014

    Report

    Report Number
    0001825034-2014-06808
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    September 28, 2012
    Report Date
    November 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 9 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06806 / 06814).

    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS NUMBER 3 OF 12 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06806 / 06814 AND 08235 / 08237).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. ALL COMPONENTS WERE REMOVED AND REPLACED. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2012 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. PATIENT UNDERWENT THIRD REVISION PROCEDURE ON (B)(6) 2012. THE CEMENT SPACER MOLDS WERE REMOVED AND REPLACED. PATIENT WAS REIMPLANTED ON (B)(6) 2012. 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 PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, A REVIEW OF INVOICE HISTORY REVEALED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012. FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED WITH A SPACER MOLD AND MODULAR HEAD. PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT FURTHER REVISION ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE HISTORY SUGGESTS THAT ALL COMPONENTS WERE REMOVED AND REPLACED. INVOICE HISTORY FURTHER REVEALS THAT PATIENT UNDERWENT A THIRD REVISION ON (B)(6) 2012 WHEREIN THE FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED WITH SPACER MOLDS. INVOICE HISTORY INDICATES THE PATIENT UNDERWENT A REIMPLANTATION PROCEDURE ON (B)(6) 2012 WHEREIN ALL COMPONENTS WERE REMOVED AND REPLACED. 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 REVEAL THE RIGHT HIP REVISION PERFORMED ON (B)(6) 2012 WAS DUE TO INFECTION. THE PATIENT'S OPERATIVE REPORT NOTED A DRAINING WOUND, PURULENT DRAINAGE/FLUID, AND NECROTIC TISSUE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACERS. ADDITIONAL INFORMATION RECEIVED IN MEDICAL RECORDS REVEAL A REVISION ON (B)(6) 2012. THE OPERATIVE REPORT NOTED REDDENED TISSUE, SEROUS FLUID, AND CYSTS IN THE ACETABULUM. THE ANTIBIOTIC SPACERS WERE REMOVED AND THE HIP WAS IMPLANTED WITH BIOMET COMPONENTS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL THE (B)(6) 2012 REVISION WAS DUE TO INFECTION. THE PATIENT'S OPERATIVE REPORT NOTED A DRAINING WOUND, CLOUDY SEROUS MATERIAL, CLOUDY FLUID, GRANULATION TISSUE, ECTOPIC OSSIFICATION, NECROTIC TISSUE, SCARRING, AND NECROSIS. ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACERS. THE (B)(6) 2012 OPERATIVE REPORT NOTED THE REVISION WAS DUE TO A DISLOCATED MONOLITHIC CEMENT SPACER. THE PATIENT'S OPERATIVE REPORT NOTED FIBRINOUS DEBRIS, CLEAR/TURBID FLUID, SCAR TISSUE, AND A DISLOCATED CEMENT HEAD. THE ANTIBIOTIC SPACERS WERE REMOVED AND THE HIP WAS REIMPLANTED WITH BIOMET COMPONENTS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, A REVIEW OF INVOICE HISTORY REVEALED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012. FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED WITH A SPACER MOLD AND MODULAR HEAD. PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT FURTHER REVISION ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE HISTORY SUGGESTS THAT ALL COMPONENTS WERE REMOVED AND REPLACED. INVOICE HISTORY FURTHER REVEALS THAT PATIENT UNDERWENT A THIRD REVISION ON (B)(6) 2012 WHEREIN THE FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED WITH SPACER MOLDS. INVOICE HISTORY INDICATES THE PATIENT UNDERWENT A REIMPLANTATION PROCEDURE ON (B)(6) 2012 WHEREIN ALL COMPONENTS WERE REMOVED AND REPLACED. 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
    457754 ARCOS CON SZ B STD 60MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 806510

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R