BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET INTERLOK 75MM FIXED I-BEAM TIBIAL PLATE

    MDR report key: 2031971 · Received March 28, 2011

    Report

    Report Number
    1825034-2011-00222
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    1825034-2011-005R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT CONFIRMED THE REPORT. MANUFACTURING HISTORY FOR BOTH LOTS REVEALED THAT THEY EACH CONSISTED OF EIGHT (8) UNITS. ALL EIGHT (8) UNITS OF THE CRUCIATE 67MM TIBIA PLATE WERE LOCATED IN BIOMET'S INTERNAL WAREHOUSE; SEVEN (7) OF THOSE UNITS WERE CONFIRMED TO BE PACKAGED CORRECTLY, WHILE ONE (1) UNIT CONTAINED THE I-BEAM 75MM FIXED TIBIA PLATE. BASED ON THIS INFORMATION, IT WAS DETERMINED THAT ONE UNIT FROM EACH LOT WAS MIXED DURING THE MANUFACTURING PROCESS. A DECISION WAS MADE TO RECALL THE PRODUCT. THIS REPORT FILED MARCH 28, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. DURING THE PROCEDURE, THE I-BEAM 75MM TIBIAL PLATE WAS OPENED AND FOUND TO CONTAIN A CRUCIATE 67MM TIBIAL PLATE. ANOTHER TIBIA PLATE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WAS NO INJURY TO THE PATIENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET INTERLOK 75MM FIXED I-BEAM TIBIAL PLATE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A J100921070

    Patients

    Seq Age Sex Outcome Treatment
    1