BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE ARCOM MENISCAL BEARING LARGE RIGHT

    MDR report key: 2160003 · Received July 13, 2011

    Report

    Report Number
    1825034-2011-00561
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    November 15, 2010
    Report Date
    June 15, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, (B)(4) STATES, "PERSISTENT PAIN". THE DEVICE IS IN A CLINICAL STUDY AND NOT AVAILABLE FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2010, DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE ARCOM MENISCAL BEARING LARGE RIGHT PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 1288541

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R