BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD -6MM NK

    MDR report key: 3813540 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-03816
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS BEING SUBMITTED ONE DAY LATE DUE TO ESG DOWNTIME ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 ALLEGEDLY DUE TO ELEVATED IRON LEVELS. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290697 28MM DIA COCR MOD HD -6MM NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 070330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R