BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TIB TRAY 41X26 RLLM

    MDR report key: 3020708 · Received March 26, 2013

    Report

    Report Number
    0001825034-2013-00743
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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 20 STATES,"PERSISTENT PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ONSET OF PAIN. THE PATIENT WAS REVISED AND A VANGUARD TOTAL KNEE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123510 OXFORD UNI TIB TRAY 41X26 RLLM PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A 931491

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R