BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H RADIAL 3-HOLE SHELL 52MM

    MDR report key: 3972771 · Received August 1, 2014

    Report

    Report Number
    0001825034-2014-06697
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    April 11, 2011
    Report Date
    July 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK861114
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 9 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿ NUMBER 19 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05688 AND 06697).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. A REVIEW OF THE INVOICE HISTORY INDICATES PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2011; HOWEVER, AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE INITIAL SURGERY DATE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THE RIGHT TOTAL HIP ARTHROPLASTY OCCURRED IN 2000. REVIEW OF INVOICE HISTORY CONFIRM RIGHT TOTAL HIP ARTHROPLASTY OCCURRED ON OR ABOUT (B)(6) 2000. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THE RIGHT HIP REVISION ON (B)(6) 2011 WAS DUE TO PAIN AND SEPTIC LOOSENING. THE PATIENT¿S OPERATIVE REPORT NOTED METAL STAINED TISSUE, ACETABULAR LOOSENING, AND METALLOSIS. 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
    451048 M/H RADIAL 3-HOLE SHELL 52MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 464020

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R