BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3231133 · Received July 17, 2013

    Report

    Report Number
    0001825034-2013-02728
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    September 4, 2002
    Report Date
    June 18, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS IS A DUPLICATE OF ANOTHER EVENT REPORT. PLEASE REFERENCE MEDWATCH REPORTS 1825034-2013-01408 / 01414.

    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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02727 / 02728).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002 AS WELL AS A LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT UNDERWENT AND INCISION AND DRAINAGE PROCEDURE WHERE HEMATOMA WAS DEBRIDED AND EVACUATED FROM THE LEFT HIP. SUBSEQUENTLY, THE PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2013 DUE TO AN ALLEGED ADVERSE REACTION TO METAL DEBRIS. SURGEON REMOVED AND REPLACED THE HEAD AND CUP IN ADDITION TO IMPLANTING A POLYETHYLENE LINER. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331178 UNK PROSHTESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R