BEUDAMED
    FDA Adverse Event Injury Summary report: N

    47MM OSS RS AVL SHORT TIB 8X90

    MDR report key: 3863728 · Received June 10, 2014

    Report

    Report Number
    0001825034-2014-05397
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PCUSTOMIZED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES,"IMPLANTS CAN LOOSEN OR MIGRATE DUE TO TRAUMA OR LOSS OF FIXATION."

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO LOOSE TIBIAL COMPONENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE TIBIAL COMPONENT WAS REMOVED AND REPLACED AND A PROXIMAL FEMORAL BODY WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE TIBIAL COMPONENT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340548 47MM OSS RS AVL SHORT TIB 8X90 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 689580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R