BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BEARING LT SM SIZE 3

    MDR report key: 3824088 · Received May 21, 2014

    Report

    Report Number
    0001825034-2014-04473
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    October 26, 2013
    Report Date
    March 4, 2016
    Manufacturer
    BIOMET U.K. LTD
    Product Code
    NRA
    PMA / PMN Number
    PPO10014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    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, NUMBER 13 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2013 DUE TO DISLOCATION. THE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303110 OXF ANATOMIC BEARING LT SM SIZE 3 PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A 3059154

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R