BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET INTERLOK FIXED CRUCIATE PLATE 79MM WITH LOCKING BAR

    MDR report key: 1760104 · Received July 16, 2010

    Report

    Report Number
    1825034-2010-00280
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 22, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(6) 2010 WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND THE ATTACHED USER FACILITY REPORT ARE FOR THE SAME PATIENT, PART NUMBER AND EVENT.(B)(4)

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE. DIMENSIONAL ANALYSIS FOUND THE COMPONENT WAS WITHIN DESIGN SPECIFICATIONS.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.(B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B) (6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B) (6) 2010, DUE TO AN ISSUE WITH THE LOCKING BAR. THE LOCKING BAR WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO AN ISSUE WITH THE LOCKING BAR. THE LOCKING BAR WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET INTERLOK FIXED CRUCIATE PLATE 79MM WITH LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 987760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R