BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 48MM

    MDR report key: 3770166 · Received April 24, 2014

    Report

    Report Number
    0001825034-2014-03179
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    August 27, 2013
    Report Date
    June 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 1 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03179 / 03184).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2009, AND A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013 AND A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, METALLOSIS, AND TISSUE DAMAGE. LEGAL COUNSEL FOR PATIENT ALLEGES THAT FLUID, GRAY-STAINED SYNOVIAL LINING, AND ADVERSE TISSUE REACTION WERE NOTED DURING THE (B)(6) 2013 REVISION PROCEDURE. LEGAL COUNSEL FOR PATIENT ALSO ALLEGES THAT CLOUDY FLUID CONSISTENT WITH ADVERSE METAL REACTION WAS NOTED DURING THE (B)(6) 2013 REVISION PROCEDURE. A REVIEW OF INVOICE HISTORY CONFIRMED THE SURGERY DATES AND THAT THE ACETABULAR CUPS, FEMORAL STEMS AND MODULAR HEADS WERE REMOVED AND REPLACED WITH ACTIVE ARTICULATION COMPONENTS DURING BOTH REVISION PROCEDURES. 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 TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2009, AND A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013 AND A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, METALLOSIS, AND TISSUE DAMAGE. LEGAL COUNSEL FOR PATIENT ALLEGES THAT FLUID, GRAY-STAINED SYNOVIAL LINING, AND ADVERSE TISSUE REACTION WERE NOTED DURING THE (B)(6) 2013 REVISION PROCEDURE. LEGAL COUNSEL FOR PATIENT ALSO ALLEGES THAT CLOUDY FLUID CONSISTENT WITH ADVERSE METAL REACTION WAS NOTED DURING THE (B)(6) 2013 REVISION PROCEDURE. A REVIEW OF INVOICE HISTORY CONFIRMED THE SURGERY DATES AND THAT THE ACETABULAR CUPS, FEMORAL STEMS AND MODULAR HEADS WERE REMOVED AND REPLACED WITH ACTIVE ARTICULATION COMPONENTS DURING BOTH REVISION PROCEDURES. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE LEFT HIP REVISION PROCEDURE PERFORMED ON (B)(6) 2013 WAS DUE TO PAIN, FLUID, ELEVATED METAL LEVELS AND ADVERSE LOCAL TISSUE REACTION. THE PATIENT'S OPERATIVE REPORT NOTED CLOUDY FLUID CONSISTENT WITH ADVERSE METAL REACTION, SYNOVIAL TISSUE, AND BLACK STAINING. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE RIGHT HIP REVISION PROCEDURE PERFORMED ON (B)(6) 2013 WAS DUE TO PAIN, FLUID, AND ADVERSE LOCAL TISSUE REACTION. THE PATIENT'S OPERATIVE REPORT NOTED FLUID WITH GRAY-STAINED SYNOVIAL-LIKE LINING, AN ADVERSE LOCAL TISSUE REACTION, AND BLACK STAINING. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2013, (B)(6) 2013 AND (B)(6) 2014 PATIENT'S BLOOD WAS TESTED. 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
    248770 M2A-38 CUP NON FLARED SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 658990

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R