BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANATOMIC BEARING RT MD SIZE 4 PMA

    MDR report key: 3951101 · Received July 22, 2014

    Report

    Report Number
    0001825034-2014-06379
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    March 7, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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

    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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 TO REMOVE AND REPLACE ALL COMPONENTS WITH A TOTAL KNEE SYSTEM FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO UNSPECIFIED COMPLICATIONS ON THE LATERAL SIDE OF THE PATIENT'S KNEE. ALL COMPONENTS WERE REMOVED AND A TOTAL KNEE SYSTEM WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO UNSPECIFIED COMPLICATIONS ON THE LATERAL SIDE OF THE PATIENT'S KNEE. ALL COMPONENTS WERE REMOVED AND A TOTAL KNEE SYSTEM WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO DISEASE PROGRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427955 OXFORD ANATOMIC BEARING RT MD SIZE 4 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 2952005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R