BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BRG LT SM SIZE 6

    MDR report key: 3830699 · Received May 23, 2014

    Report

    Report Number
    0001825034-2014-04781
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    March 7, 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
    WI, 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 DEVIATION. 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."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY EVENT/REVISION DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE DUE TO POSSIBLE INFECTION. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO POSSIBLE INFECTION. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO POSSIBLE INFECTION. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308056 OXF ANATOMIC BRG LT SM SIZE 6 PROSTHESIS, HIP NRA BIOMET U.K. LTD N/A 2560122

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R