BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAC KNEE TIBIAL BEARING 12MM THICK X 65MM WIDE

    MDR report key: 2072148 · Received April 28, 2011

    Report

    Report Number
    1825034-2011-00317
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    February 7, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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: UNDER PRECAUTIONS, IT STATES, "LATE POSTOPERATIVE COMPLICATIONS MAY INCLUDE: ... WEAR OR DEFORMATION OF THE ARTICULAR SURFACES MAY OCCUR AS A RESULT OF EXCESSIVE LOADING". 510(K) NUMBER - THIS PRODUCT WAS INCLUDED IN AN (B)(4). THE PRODUCT WAS NEVER MARKETED AND THE IDE STUDY WAS CLOSED IN 2005. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY ON (B)(6), 1999. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO POLY WEAR. THE POLY BEARINGS IN BOTH KNEES WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAC KNEE TIBIAL BEARING 12MM THICK X 65MM WIDE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 063580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R