BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRD PS TIB BRG 18X79/83

    MDR report key: 3844608 · Received June 3, 2014

    Report

    Report Number
    0001825034-2014-05138
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    November 29, 2011
    Report Date
    May 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    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.¿ NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY.¿ THIS REPORT IS NUMBER 2 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05137 / 05142).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2008 WHERE SPACER MOLDS WERE IMPLANTED DUE TO INFECTION. ON (B)(6) 2008, PATIENT WAS REIMPLANTED WITH A TOTAL KNEE SYSTEM. SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT ON (B)(6) 2008 DUE TO HEMATOMA. PATIENT UNDERWENT MANIPULATION OF THE RIGHT KNEE SECONDARY TO ARTHROFIBROSIS ON (B)(6) 2008. SUBSEQUENTLY PATIENT UNDERWENT A REVISION PROCEDURE ON NOVEMBER 29, 2011 DUE TO ASEPTIC LOOSENING AND ARTHROFIBROSIS. PATIENT UNDERWENT MANIPULATION OF THE RIGHT KNEE ON (B)(6) 2012 DUE TO ANKYLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324181 VANGRD PS TIB BRG 18X79/83 PROSTHESIS, HIP JWH BIOMET ORTHOPEDICS N/A 269140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R