BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2A / M2A SYSTEM W/PLUG 52MM O.D. SHELL SIZE 41MM I.D. TAPER

    MDR report key: 6042207 · Received October 19, 2016

    Report

    Report Number
    0001825034-2016-04171
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    April 3, 2014
    Report Date
    September 19, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDL
    PMA / PMN Number
    PK042841
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 14 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN.¿ 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 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-01516 / 01517 & 04171).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED A LEFT HIP REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, SYNOVITIS, ELEVATED METAL ION LEVELS, AND METALLOSIS. LEGAL COUNSEL ALLEGED SYNOVITIS AND ANTERIOR ACETABULAR CYSTIC CHANGES CONSISTENT WITH METAL-ON-METAL BEARING FAILURE WERE NOTED DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION WAS RECEIVED IN PATIENT'S MEDICAL RECORDS, CONFIRMING PATIENT WAS REVISED APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO INSTABILITY, UNSPECIFIED MECHANICAL COMPLICATIONS, SYNOVITIS, AND LEG LENGTH DISCREPANCY. OPERATIVE REPORT INDICATED ACETABULAR CYSTIC CHANGES, MILKY FLUID, CORROSION AND A CYST FILLED WITH BLACK MATERIAL WITHIN THE JOINT. OPERATIVE FURTHER INDICATED THE ACETABULAR COMPONENT WAS MALPOSITIONED. THE ACETABULAR CUP AND FEMORAL HEAD WERE REMOVED AND REPLACED, AND AN ACTIVE ARTICULATION BEARING WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690405 C2A / M2A SYSTEM W/PLUG 52MM O.D. SHELL SIZE 41MM I.D. TAPER PROSTHESIS, HIP JDL BIOMET ORTHOPEDICS N/A 775050

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R