BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL PS

    MDR report key: 5208022 · Received November 6, 2015

    Report

    Report Number
    3004153240-2015-00209
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    October 1, 2015
    Report Date
    November 6, 2015
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT SURGERY. THE SURGEON REPORTED THAT THE PATIENT HAD RECURRING HIVES, BODILY SWELLING, AND GENERAL ALLERGY TYPE SYMPTOMS THROUGHOUT HIS BODY FOLLOWING SURGERY. CAUSE OF SYMPTOMS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. REPORT IS FOR BILATERAL SURGERY. SERIAL NUMBERS AND MODEL NUMBERS IMPLANTED: SN (B)(4) TPS-111-1111-010101. SN (B)(4) TPS-111-1111-020101.

    Description of Event or Problem · 1

    PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT SURGERY. THE SURGEON REPORTED THAT THE PATIENT HAD RECURRING HIVES, BODILY SWELLING, AND GENERAL ALLERGY TYPE SYMPTOMS THROUGHOUT HIS BODY FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739250 ITOTAL PS TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC. TPS-111-1111-010101

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other