BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSALL-BURNSTEIN TOTAL KNEE SYSTEM

    MDR report key: 35714 · Received June 26, 1996

    Report

    Report Number
    35714
    Event Type
    Malfunction
    Date Received
    June 26, 1996
    Date of Event
    September 14, 1995
    Report Date
    June 26, 1996
    Manufacturer
    ZIMMER, INC.
    Product Code
    FWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A LEFT TOTAL KNEE REPLACEMENT DONE ON 9/14/95 IN PHILADELPHIA. THERE IS SOME QUESTION AS TO PT DEVELOPING A WOUND INFECTION AND WOUND DEHISCENCE IN THE POST-OP PERIOD, REQUIRING DEBRIDEMENT AND SKIN GRAFTING. IT IS NOT CLEAR WHETHER THE JOINT ITSELF WAS DEBRIDED. THIS INFO IS OBTAINED FROM THE PT, WHO ALSO NOTES HE WAS IN THE HOSP FOR 4 MONTHS AT THE TIME OF HIS REPLACEMENT SURGERY. HE ALSO NOTES THAT SINCE THE TIME OF HIS SECOND SURGICAL PROCEDURE AND SKIN GRAFTING AT THE LEFT KNEE, HE HAS HAD A SCAB DIRECTLY OVER THE ANTERIOR ASPECT OF THE LEFT KNEE WHICH HAS INTERMITTENTLY FALLEN OFF AND DRAINED. RECENTLY, OVER A PERIOD OF SEVERAL DAYS, HE HAD DEVELOPED PAINFUL ERTHYEMA AND SWELLING OF THE LEFT LOWER EXTERMITY. HE WAS ADMITTED TO THE HOSP ON 5/9/96 AND PLACED ON IV ANTIBIOTICS AND HEPARIN. A C&S OF PUS FROM THE KNEE JOINT GREW STAPH AUREUS AND PSEUDOMONAS. ORTHOPEDIC CONSULT RECOMMENDED DUE TO THE EXTENSIVE BONE INVOLVEMENT AND CELLULITIS OF LOWER LEG, ALL WOULD INDICATE POOR PROGNOSIS FOR ANY JOINT DEBRIDEMENT AND FUTURE ATTEMPTS TO BE REIMPLANTED OR ATTEMPT TO FUSE KNEE. ON 5/15/96 PT UNDERWENT A LEFT ABOVE THE KNEE AMPUTATION. FINDINGS WERE INFECTED LEFT TOTAL KNEE REPLACEMENT WITH OSTEOMYELITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSALL-BURNSTEIN TOTAL KNEE SYSTEM TOTAL KNEE SYSTEM FWH ZIMMER, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO