BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANATOMIC BRG LT SM SIZE 4

    MDR report key: 3120822 · Received May 20, 2013

    Report

    Report Number
    0001825034-2013-01580
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    July 22, 2010
    Report Date
    February 12, 2016
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 1 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."

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT A UNICOMPARTMENTAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PAIN. IT WAS NOTED DURING THE PROCEDURE THERE WAS BEARING IMPINGEMENT ANTERIORLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT A LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PAIN. IT WAS NOTED DURING THE PROCEDURE THERE WAS BEARING IMPINGEMENT ANTERIORLY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE REVISION PROCEDURE ON (B)(6) 2008, PATIENT WAS REVISED TO A TOTAL KNEE SYSTEM. OPERATIVE REPORT NOTES THAT THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT A LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PAIN. IT WAS NOTED DURING THE PROCEDURE THERE WAS BEARING IMPINGEMENT ANTERIORLY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE REVISION PROCEDURE ON (B)(6) 2010, PATIENT WAS REVISED TO A TOTAL KNEE SYSTEM. OPERATIVE REPORT NOTES THAT THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221577 OXF ANATOMIC BRG LT SM SIZE 4 PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 1535255

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R