BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 2994358 · Received March 5, 2013

    Report

    Report Number
    3009897021-2012-00025
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 4, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT HAD A HISTORY OF INFECTIONS RELATED TO THE TOTAL KNEE ARTHROPLASTY, AND IT CANNOT BE DETERMINED THAT THE INFECTION WAS PRE-EXISTING PRIOR TO V.A.C. THERAPY. NO ADD'L INFO IS AVAILABLE. THE CUSTOMER HAS NOT PROVIDED THE UNIT'S SERIAL NUMBER, THEREFORE, KCI CANNOT CONDUCT A DEVICE EVAL OF THE UNIT. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NON-INFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS WOUND CONDITIONS, TREATMENT GOALS, AND INSTILLATION THERAPY PARAMETERS (FOR THE V.A.C. INSTILL THERAPY SYSTEM). REFER TO DRESSING CARTONS) FOR DETAILS REGARDING DRESSING CHANGE FREQUENCY. AS WITH ANY WOUND TREATMENT, CLINICIANS AND PTS/CAREGIVERS SHOULD FREQUENTLY MONITOR THE PT'S WOUND, PERIWOUND TISSUE AND EXUDATE FOR SIGNS OF INFECTIONS. SOME SIGNS OF INFECTION ARE FEVER, TENDERNESS, REDNESS, SWELLING, ITCHING, RASH, INCREASED WARMTH IN THE WOUND OR PERIWOUND AREA, PURULENT DISCHARGE, OR STRONG ODOR. INFECTION CAN BE SERIOUS, AND CAN LEAD COMPLICATIONS SUCH AS PAIN, DISCOMFORT, FEVER, GANGRENE, TOXIC SHOCK, SEPTIC SHOCK AND/OR FATAL INJURY. SOME SIGNS OF COMPLICATIONS OF SYSTEMIC INFECTION ARE NAUSEA, VOMITING, DIARRHEA, HEADACHE, DIZZINESS, FAINTING, SORE THROAT WITH SWELLING OF THE MUCUS MEMBRANES, DISORIENTATION, HIGH FEVER, REFRACTORY AND/OR ORTHOSTATIC HYPOTENSION OR ERYTHRODERMA (A SUNBURN-LIKE RASH). IF THERE ARE ANY SIGNS OF THE ONSET OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUND SITE, CONTACT THE TREATING PHYSICIAN IMMEDIATELY TO DETERMINE IF V.A.C. THERAPY WOULD BE DISCONTINUED.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE KCI (B)(4) REP: ON AN UNK DATE, FOLLOWING TWO PRIOR FAILED TOTAL KNEE REPLACEMENTS DUE TO INFECTIONS, THE PT RECEIVED A THIRD TOTAL KNEE REPLACEMENT. THE THIRD PROSTHETIC PROCEDURE WAS DEEMED SUCCESSFUL UNTIL THE PT FELL AND INCURRED A PERIPROSTHETIC FRACTURE OF THE DISTAL FEMUR (DATE UNK). THE TOTAL KNEE WAS REVISED. THE PT ACQUIRED A HEMATOMA AND SUPERINFECTION FOLLOWING THE REVISION. THE INFECTED WOUND WAS THEN TREATED WITH V.A.C. THERAPY, PARTIALLY WITH V.A.C. INSTILL, FOR A TOTAL OF 6-7 MONTHS, INCLUDING NUMEROUS REVISIONS (THERAPY DATES UNK). IT WAS REPORTED THAT A NUMBER OF SUPERINFECTIONS FOLLOWED ONE AFTER THE OTHER DURING V.A.C. THERAPY. THE REPORTING SURGEON DISCONTINUED V.A.C. THERAPY (DATE UNK), REMOVED THE REMNANT SPACER IN THE KNEE, AND COMMENCED ANTIBIOTIC THERAPY. A NUMBER OF FURTHER KNEE REVISIONS WERE NEEDED, RESULTING IN REIMPLANTATION FOLLOWING THE SUCCESSFUL REMOVAL OF THE INFECTION (DATE UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93815 V.A.C. THERAPY OMP KCI USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention