BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE MEDIUM

    MDR report key: 2081995 · Received May 9, 2011

    Report

    Report Number
    1825034-2011-00362
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    March 18, 2010
    Report Date
    April 11, 2011
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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: "FATIGUE FRACTURE OF COMPONENTS CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." EVALUATION OF THE RETURNED COMPONENT FOUND THE POSTERIOR FEMORAL CONDYLE APPEARED TO HAVE FRACTURED DUE TO POSSIBLY INSUFFICIENT BONE CEMENT TO SUPPORT THE POSTERIOR CONDYLE. IN DEEP FLEXION, THIS COULD HAVE PUT THE POSTERIOR LOAD ON THE POST, CAUSING THE FEMORAL COMPONENT TO FLEX UNDER LOAD, WHICH LED TO THE FATIGUE FRACTURE. THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION - CORRECTED THE DATE OF THE REVISION PROCEDURE TO (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND WAS SUBSEQUENTLY REVISED DUE TO PAIN. DURING THE REVISION PROCEDURE PERFORMED ON (B)(6) 2010, FEMORAL COMPONENT WAS NOTED TO BE FRACTURED. PATIENT WAS REVISED TO TOTAL KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND WAS SUBSEQUENTLY REVISED DUE TO PAIN. DURING REVISION PROCEDURE PERFORMED ON (B)(6), 2011, FEMORAL COMPONENT WAS NOTED TO BE FRACTURED. PATIENT WAS REVISED TO TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE MEDIUM PROSTHESIS, KNEE NRA BIOMET UK LTD N/A 881417

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R