BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BRG RT LG SIZE 4

    MDR report key: 3871978 · Received June 13, 2014

    Report

    Report Number
    0001825034-2014-05393
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 21, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 WARNINGS, NUMBER 1 STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS."

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO A POSTERIORLY DISLOCATED TIBIAL BEARING AND MIDFLEXION INSTABILITY. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350895 OXF ANATOMIC BRG RT LG SIZE 4 PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 2194070

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R