BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE LARGE

    MDR report key: 2222157 · Received August 24, 2011

    Report

    Report Number
    1825034-2011-00736
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    May 4, 2011
    Report Date
    July 28, 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: "PERSISTENT PAIN." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2011-00736 / 00738). THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6), 2007. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 TO REMOVE AND REPLACE ALL COMPONENTS DUE TO PAIN. THE PATIENT WAS REVISED TO A TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE LARGE PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 382581

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R