BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SERIES A STANDARD PATELLA 28MM X 8.0MM

    MDR report key: 2222200 · Received August 24, 2011

    Report

    Report Number
    1825034-2011-00745
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K040770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY. DATE OF EVENT - A REVISION SURGERY IS SCHEDULED FOR (B)(4), 2011. DATE EXPLANTED - COMPONENT HAS NOT BEEN REVISED TO DATE. A REVISION SURGERY IS SCHEDULED FOR (B)(4), 2011. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FORWARDED TO THE FDA. THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT A REVISION PROCEDURE OCCURRED ON (B)(4), 2011. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2011 AND THAT A REVISION PROCEDURE IS SCHEDULED FOR (B)(6), 2011 TO ADDRESS ASEPTIC LOOSENING. ONLY THE POLYETHYLENE PATELLA IS BIOMET MANUFACTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 TO ADDRESS ASEPTIC LOOSENING. ONLY THE POLYETHYLENE PATELLA IS BIOMET MANUFACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET SERIES A STANDARD PATELLA 28MM X 8.0MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 684630

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R