BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BEARING RT MD SIZE 4

    MDR report key: 3785215 · Received May 1, 2014

    Report

    Report Number
    0001825034-2014-03463
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 16, 2014
    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
    PA, 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. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03463 / 03465).

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND IMPLANT TO BE OUT OF DESIGN SPECIFICATIONS. A DIMENSIONAL LAYOUT REVEALED THE COMPONENT WAS OVERSIZED IN THICKNESS. HOWEVER, THE OVERSIZED DIMENSIONS WOULD HAVE PROVIDED MORE STABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PARTIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014, FOR AN UNKNOWN REASON. ALL OXFORD PARTIAL KNEE COMPONENTS WERE REMOVED AND REPLACED WITH VANGUARD TOTAL KNEE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262036 OXF ANATOMIC BEARING RT MD SIZE 4 PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A 2919979

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R