BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BRG LT SM SIZE 5

    MDR report key: 3800943 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03771
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 4, 2016
    Manufacturer
    BIOMET UK 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 RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DEVICE DISCARDED.

    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 PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2013. REVIEW OF RADIOGRAPHS REVEALED A DISLOCATED TIBIAL BEARING. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277504 OXF ANATOMIC BRG LT SM SIZE 5 PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 2769587

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R