BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI FEMORAL LG

    MDR report key: 3964401 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06519
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    June 9, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 10 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 3002806535-2017-00479.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT ALLEGES PAIN AND MIGRATION OF THE FEMORAL COMPONENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT ALLEGES IMPLANT MIGRATION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT ALLEGES PAIN AND IMPLANT MIGRATION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440776 OXFORD UNI FEMORAL LG PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 1454958

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R