BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BEARING RT MD SIZE 6

    MDR report key: 3828878 · Received May 23, 2014

    Report

    Report Number
    0001825034-2014-04728
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 23, 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
    FL, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT 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." UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 19 STATES, ¿PERSISTENT PAIN." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04728 / 04730).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6), 2014 DUE TO PAIN AND MALPOSITIONING OF THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308765 OXF ANATOMIC BEARING RT MD SIZE 6 PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A 1880051

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R