BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE MENISCAL BEARING

    MDR report key: 2172227 · Received July 22, 2011

    Report

    Report Number
    1825034-2011-00574
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    March 14, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 20 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 PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011, DUE TO PAIN AND INTERNAL BLEEDING IN THE KNEE. THE PATIENT WAS REVISED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE MENISCAL BEARING PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 326284

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R