BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC BIPOLAR 28X51MM

    MDR report key: 5919542 · Received August 31, 2016

    Report

    Report Number
    0001825034-2016-03413
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    April 7, 2016
    Report Date
    August 25, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. PMA 510(K): - THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S., HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED IN THE UNITED STATES UNDER 510K NUMBER K051569. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE AND A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A TOTAL HIP ARTHROPLASTY, THE SURGEON WAS NOT SATISFIED WITH THE ARTICULATION BETWEEN THE ACETABULAR COMPONENT AND FEMORAL HEAD. THE COMPONENTS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570332 E1 RINGLOC BIPOLAR 28X51MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 661820

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention