BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANG XP INLK PRI TIB TRAY 75MM

    MDR report key: 3803236 · Received May 9, 2014

    Report

    Report Number
    0001825034-2014-03817
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    March 4, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK122160
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES "INTRAOPERATIVE BONE PERFORATION OR FRACTURE MAY OCCUR, PARTICULARLY IN THE PRESENCE OF POOR BONE STOCK CAUSED BY OSTEOPOROSIS, BONE DEFECTS FROM PREVIOUS SURGERY, BONE RESORPTION, OR WHILE INSERTING THE DEVICE." NUMBER 15 STATES "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE TIBIAL ISLAND FRACTURED AFTER CEMENTING THE FINAL COMPONENTS IN PLACE AND THE KNEE WAS PUT THROUGH FULL EXTENSION. THE TIBIAL ISLAND WAS SECURED WITH A 6.5 MM LOW PROFILE SELF-TAPPING BONE SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE TIBIAL ISLAND FRACTURED AFTER CEMENTING THE FINAL COMPONENTS IN PLACE AND THE KNEE WAS PUT THROUGH FULL EXTENSION. THE TIBIAL ISLAND WAS SECURED WITH A 6.5MM LOW PROFILE SELF-TAPPING BONE SCREW. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, IT WAS REPORTED PATIENT HAD FLEXION CONTRACTURE ASSOCIATED WITH PATIENT ANATOMY IN BOTH KNEES ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281988 VANG XP INLK PRI TIB TRAY 75MM PROSTHESIS, KNEE KWS BIOMET ORTHOPEDICS N/A 936250

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R