BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM MD PMA

    MDR report key: 3823939 · Received May 21, 2014

    Report

    Report Number
    0001825034-2014-04483
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 3, 2016
    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
    TN, US
    Reporter Occupation
    OTHER

    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 ASSOCIATED DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, ¿EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04482 / 04484).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY ON (B)(6) 2013 AND A LEFT KNEE REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. OXFORD KNEE COMPONENTS WERE REMOVED AND HAND MOLDED ANTIBIOTIC SPACERS WERE IMPLANTED. SUBSEQUENTLY, ON (B)(6) 2014 PATIENT WAS REVISED BY REIMPLANTATION OF TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303228 OXF TWIN-PEG CMNTD FEM MD PMA PROSTHESIS, KNEE NRA BIOMET U.K. LTD N/A 3020402

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R