BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF PKS ANAT MEN BRG UHMWPE RT XLRG SZ 4

    MDR report key: 5457505 · Received February 24, 2016

    Report

    Report Number
    0001825034-2016-00624
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    August 16, 2010
    Report Date
    March 9, 2016
    Manufacturer
    BIOMET UK LDT
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL PATIENT UNDERWENT A RIGHT PARTIAL KNEE PROCEDURE ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2010 DUE TO RECURRENT HEMARTHROSIS AND SWELLING. DURING THE PROCEDURE, YELLOW FLUID WAS REMOVED FROM THE KNEE, PATELLOFEMORAL DISEASE, A PROMINENT OSTEOPHYTE AND SYNOVITIS WERE NOTED, AND A SYNOVECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114372 OXF PKS ANAT MEN BRG UHMWPE RT XLRG SZ 4 PROSTHESIS, KNEE NRA BIOMET UK LDT N/A 274692

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R