BEUDAMED
    FDA Adverse Event Summary report: N

    PINNACLE

    MDR report key: 2802648 · Received September 17, 2012

    Report

    Report Number
    2802648
    Date Received
    September 17, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 17, 2012
    Manufacturer
    DEPUY, INC.
    Product Code
    KWA
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    HIP REPLACEMENT SURGICAL SITE INFECTION.PATIENT PRESENTS AT THE HOSPITAL AFTER BEING SEEN IN ORTHOPEDIC FOR FOLLOW UP ON RIGHT HIP ARTHROPLASTY. PATIENT HAD ELECTIVE RIGHT HIP ARTHROPLASTY APPROXIMATELY TWO WEEKS PRIOR DUE TO SEVERE CHRONIC PAIN AFTER FAILURE WITH MORE CONSERVATIVE METHODS. PATIENT WAS DISCHARGED HOME APPROXIMATELY 4 DAYS AFTER SURGERY IN STABLE CONDITION. WHEN PATIENT FOLLOWED UP IN ORTHOPEDIC CLINIC, MD NOTICED SOME ERYTHEMA AT THE SITE OF INCISION, AND HAD THE PATIENT ADMITTED TO THE HOSPITAL. THE SAME DAY, THE PATIENT NOTICED INCREASED AMOUNT OF SEROSANGUINOUS FLUID AND WAS TAKEN TO OR FOR IRRIGATION AND DEBRIDEMENT BY THE DR. A 600 CC ORGANIZED HEMATOMA WAS EVACUATED. INTRA OP CULTURES POSITIVE FOR ENTEROCOCCUS FAECALIS. PATIENT WAS DISCHARGED HOME AFTER PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) PLACEMENT ON IV ANTIBIOTICS. FIRST SURGERY PERFORMED IN ROOM #2. SKIN PREP ALCOHOL AND DURAPREP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL KWA DEPUY, INC. 309015 *
    2 PINNACLE SCREW, FIXATION, BONE HWC DEPUY MITEK 309015 *
    3 SUMMIT DUOFIX HA PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG DEPUY, INC 309015 *
    4 PINNACLE SCREW, FIXATION, BONE HWC DEPUY MITEK 309015 1217-25-500
    5 ARTICUL/EZE 12/14 BIOLOX PROSTHESIS, FEMORAL HEAD, HIP KWA DEPUY,INC 309015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR