BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK INTLK FEMORAL 65 RT

    MDR report key: 3910916 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05902
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    July 11, 2011
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 1 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05902/05907).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTY PROCEDURES ON UNKNOWN DATES. SUBSEQUENTLY, A BILATERAL REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 TO REMOVE AND REPLACE ALL COMPONENTS DUE TO INFECTION. BIOMET TOTAL KNEES WERE REIMPLANTED ON (B)(6) 2011. IT WAS FURTHER REPORTED THAT A RIGHT KNEE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 WHERE ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS AND A RADICAL DEBRIDEMENT TOOK PLACE DUE TO INFECTION. A FRACTURE ON THE MEDIAL CONDYLE AND A FRACTURE OF THE PROXIMAL TIBIA WERE NOTED DURING THE REVISION PROCEDURE AND THE CONDYLE WAS SECURED WITH K-WIRES. SUBSEQUENTLY, PATIENT UNDERWENT A REIMPLANTATION PROCEDURE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387400 VANGUARD SSK INTLK FEMORAL 65 RT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 325140

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R