BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGRD PS TIB BRNG 63/67X12

    MDR report key: 2823792 · Received November 8, 2012

    Report

    Report Number
    0001825034-2012-02383
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    December 8, 2011
    Report Date
    October 18, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK080528
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 6 STATES: "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND NUMBER 15 "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THE FOLLOWING SECTION COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. THIS REPORT IS NUMBER 2 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02382 / 02386).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. PATIENT REPORTS ALLEGED PAIN, INFLAMMATION, FLUID BUILDUP, AND ISSUES OF STRAIGHTENING KNEE. TO DATE, NO KNOWN REVISION IS SCHEDULED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNGRD PS TIB BRNG 63/67X12 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 508010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention