BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE REPLACEMENT

    MDR report key: 574 · Received May 13, 1992

    Report

    Report Number
    574
    Event Type
    Injury
    Date Received
    May 13, 1992
    Date of Event
    April 14, 1992
    Report Date
    April 23, 1992
    Manufacturer
    INTERMEDICS ORTHOPEDICS, INC.
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 5TH POD, PATIENT DEVELOPED INFECTION WITH DRAINAGE FROM INCISION. PLASTIC PORTION OF PROSTHESIS REMOVED. THREE ADDITIONAL DEBRIDEMENT PROCEDURES ALSO PERFORMED. ON 9TH POD, ENTIRE PROSTHESIS WAS REMOVEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, UNANTICIPATED. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INVALID DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Implant TOTAL KNEE REPLACEMENT HRY INTERMEDICS ORTHOPEDICS, INC. 71823, 46091, 43080, 71562

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other