BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 75MM

    MDR report key: 2595116 · Received May 31, 2012

    Report

    Report Number
    0001825034-2012-00722
    Event Type
    Injury
    Date Received
    May 31, 2012
    Report Date
    May 2, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    BSN
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THAT THE TIBIAL TRAY AND FEMORAL STEM WERE FOUND TO BE LOOSE DURING THE REVISION PROCEDURE. THIS WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOUR STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY." THIS FOLLOW-UP REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00722-1 / 00723-1).

    Additional Manufacturer Narrative · 1

    EVENT DATE - SOMETIME IN (B)(6) 2011. EXPLANTED DATE - SOMETIME IN (B)(6) 2011. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. 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 TWO STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION". NUMBER FIFTEEN STATES, "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN" REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00722 / 00725).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED IN (B)(6) 2011 ALLEGEDLY DUE TO PAIN AND INFECTION. OPERATIVE NOTES INDICATE THAT THE TIBIAL PLATE AND FEMORAL STEM WERE FOUND TO BE LOOSE DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, PATIENT WAS REVISED IN (B)(6) OF 2011 DUE TO PAIN AND INFECTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET CC I-BEAM TRAY 75MM PROSTHESIS, KNEE BSN BIOMET ORTHOPEDICS N/A 437840

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R