BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 71MM

    MDR report key: 3120840 · Received May 20, 2013

    Report

    Report Number
    0001825034-2013-01584
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE PRODUCT AND LOT INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 WARNINGS, NUMBER 3 STATES, "THE LOCKING BAR USED TO SECURE THE TIBIAL PLATE AND TIBIAL-BEARING COMPONENTS TOGETHER MUST LOCK SECURELY INTO PLACE WITH AN AUDIBLE CLICK AT THE TIME OF IMPLANTATION. DISASSOCIATION OF THE LOCKING BAR FROM THE MODULAR TIBIAL PLATE COMPONENT HAS BEEN REPORTED. INADEQUATE SEATING OF THE LOCKING BAR CAN CAUSE DISASSOCIATION OF THE LOCKING BAR FROM THE TIBIAL PLATE COMPONENT, REQUIRING REVISION SURGERY."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE INITIAL PROCEDURE DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, X-RAYS SHOW THE LOCKING BAR HAS BACKED OUT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN (B)(6) 2008. SUBSEQUENTLY, X-RAYS SHOW THE LOCKING BAR HAS BACKED OUT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221593 BIOMET CC CRUCIATE TRAY 71MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 507880

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R