BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BEARING RT LG SIZE 3

    MDR report key: 3782106 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03332
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 24, 2013
    Report Date
    March 1, 2016
    Manufacturer
    BIOMET U.K. LTD
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. PRODUCT LOCATION UNKNOWN.

    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 ASSOCIATED DEVIATION. 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". THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03332 / 03333).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY. PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2008 AND LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT'S RIGHT PARTIAL KNEE WAS REVISED TO TOTAL KNEE ON (B)(6) 2013, DUE TO PAIN. PATIENT'S LEFT KNEE WAS REVISED TO TOTAL KNEE ON (B)(6) 2013, DUE TO DETERIORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260962 OXF ANATOMIC BEARING RT LG SIZE 3 PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A 1198736

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R