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7. Upon notice opposite parties appeared and filed joint written statement taking preliminary objections to the effect that the complaint is a flagrant abuse of the process of law and has been filed in order to harass, malign and blackmail the opposite parties.

The complainant has not produced any documentary or expert evidence to prove that there was any negligence on the part of the opposite parties. The complaint is bad for non-joinder of necessary parties inasmuch as Sir Ganga Ram Hospital has not been impleaded as a party in the complaint. The complainant has not approached this Commission with clean hands and has distorted the material facts with a view to mislead this Commission, which would show that the complainant had always been promptly attended to in line with the standard practice. With regard to the facts of the case it is averred that the complainant had come to opposite party No.4 on 12.4.2011 and 9.5.2011 with pain and swelling in both knees since 10 years which was associated with difficulty in walking and climbing stairs. She was having osteoarthritis of both knees and was advised Bilateral Total Knee Replacement (in short, "TKR"). Osteoarthritis results into wear and tear of joints with age, which further results in pain, stiffness and deformity. In TKR worn out surfaces of knee joint are removed and replaced with implants called prosthesis resulting improving quality of life and decreasing pain. The complainant was admitted in opposite parties Nos.1 to 3-Hospital on 19.5.2011 for undergoing TKR and after having been explained everything including risks and complication of TKR including risk of infection, a written consent was obtained from her. On 20.5.2011 the complainant underwent TKR surgery conducted by opposite party No.4 as per standard norms. The Orthopaedic Operation Theatres are equipped with laminar flow apparatus and are subjected to regular disinfection and routine cultures. Moreover, same set of instruments were used for both the knees which were duly sterilized and the knee implant came in a pre-sterilized kit. After surgery the complainant was kept in the Ortho ICU for two days and then in the Ward for four days wherein complete protocols pertaining to infection control were followed till she was finally discharged. It is further averred that post operative the complainant had normal wound healing with no signs of soakage/discharge or fever was noted. The complainant started walking with a walker within 48 hours of her surgery. The walking distance was increasing as expected. The complainant complained of pain and stiffness especially at night but never had more than mild pain on walking. Her symptoms were similar on both the knees and were in accordance with the usual recovery period required for healing and while walking the patient took equal weight on both knees. She was discharged on 26.5.2011 in a stable condition. Thereafter her sutures were removed at routine time of 2 weeks. The wounds of both knees had healed normally by that time. The healing was similar in both knees and there was no evidence of any infection or delay in healing of either knee. It is further averred that more than 2 months after surgery on 13.8.2011 the complainant approached opposite party No.4 with sudden onset of a small (2cm x 2cm) erythematous (reddish) swelling on the inner aspect of right knee distal to the joint line. The complainant at that time had no noticeable effusion (diffuse, generalized swelling) of the joint. She was walking with a stick. She did not have any fever and the swelling was only at one side and that too distal to the joint line, which pointed that the swelling was superficial. The patient (complainant) was informed that clinically there was nothing to suggest that underlying joint was infected. However, superficial infections may spread and for that reason immediately opposite party No.5 was consulted, who clinically diagnosed it as cellulitis just below the right knee and promptly put the complainant on anti-biotic. USG done on both knees on 20.8.2011 showed similar amount of joint fluid in both the knees and in addition 3.00 cm x 1.2 cm localized fluid collection deep to the subcutaneous tissue on the anteromedial aspect of upper tibia (inner side of knee distal to the joint line), which corroborated the clinical diagnosis of a soft tissue infection. In the meantime the complainant was managed with dressings and antibiotic. She had been followed up regularly in the OPD. It is further averred that treatment of superficial infections in the setting of knee replacement consists of antibiotic therapy with or without a localized incision and drainage (I&D). However, the treatment approach is different in deep infections (deep to the joint capsule including those involving the metallic prosthesis) wherein the treatment consists of removal of the knee implant and debridement in the first stage and re-implantation of the prosthesis in the second stage after the infection had subsided. Since in the case of the complainant the clinical picture and USG were suggestive of a superficial infection, there was no need for a radical surgery in the form of 2-stage revision knee replacement at that stage. In the ensuing days, the soft tissue abscess developed a pus point superficially. Immediately aspiration of the pus was done and pus was sent for culture sensitivity, which later reported sterile. Notably the swelling and redness were still confined to small area. Opposite party No.5 came in contact with the complainant when she was sent for a general surgery consultation by opposite party No.4 and not prior to it, as is being conveyed in the complaint. Opposite party No.5 was not part of the team, who performed TKR. It is further averred that since complainant's localized abscess was not resolving with over two weeks of anti- biotic therapy and dressings, opposite party No.4 decided to perform an incision and drainage in OT. I & D is a surgery wherein an incision of 2 cm was given over the soft tissue abscess and it was drained and washed. The surgery was performed by opposite party No.4 and the same lasted 15 minutes. Intra-operatively it was found that the abscess extended till the underlying leg bone. However, there was no communication with the underlying knee joint and the knee joint was never opened in that surgery. Post operatively broad spectrum IV antibiotic was given followed by oral antibiotic on discharge. C-reactive protein levels in blood tests (markers of inflammation/infection) started decreasing after I & D, which has been documented in the Investigation Flow Chart Sheet. After I&D the wound showed signs of healing and the discharge stopped. However, about a week after I&D, the discharge reappeared. Serial bacterial cultures were done but were always sterile. Thereafter the complainant underwent daily dressings under the supervision of opposite party No.4. The complainant used to walk around comfortably from the Hospital entrance to the dressing room. The complainant was regularly asked about any pain on walking to which she replied in negative. Hence the allegation that she was bedridden after surgery is false; rather, she was walking comfortably after surgery, as is apparent from Annexure C-4 (page 142 of the complaint), which is as per history given by the complainant to the Doctors of Sir Ganga Ram Hospital. It is further averred that since the wound discharge was not resolving despite anti-biotic and dressings, the complainant was encouraged to take a second opinion. Opposite party No.4 arranged consultation with Prof. Ramesh K. Sen at PGIMER, Chandigarh. The complainant was examined by Dr. Sen and his team, who advised repeating bacterial cultures after stopping anti-biotic for a week and told that the same treatment as given by opposite party No.4 should be continued. However, the wound discharge showed an increase in amount and also the nature of discharge became thin and watery, which suggested that the abscess had eroded into the joint capsule and led to a communication with the knee joint resulting leakage of synovial fluid along with discharge. That implied an underlying communication and infection of the knee plant. Therefore, the decision to remove the right knee implant was taken. A revision knee replacement in the setting of infection as in the case of complainant is done in two stages. In the first stage the main aim is to eradicate infection. During this stage all the foreign material, which means the implant and the cement is removed and all visible infective tissue is excised and cleaned. In place of the implant an anti-biotic spacer is inserted which can elute anti-biotic to control the infection. Once infection is controlled the next stage involves insertion of new implant. In order to undergo debridement and implant removal, the complainant was admitted in opposite parties Nos.1 to 3-Hospital on 19.10.2011 and the right knee debridement with implant removal was done on 20.10.2011 and antibiotic loaded cement spacer was inserted. Only after insertion of the cement spacer the complainant was advised to do bed rest. Therefore, the impression which the complainant is trying to convey implying as if she had been on bed rest after her TKR surgery conducted in May 2011 is absolutely incorrect and on the contrary she was walking comfortably after TKR. However even after removing the implants, the wound discharge began after a period of one week. The complainant was told that more than one debridement (wound cleaning) is often needed in similar cases and that a new knee implant could not be inserted till infection subsides completely. However by that time the complainant was taking several other opinions of her own and started getting irregular with dressings and was not interested in continuing treatment with opposite parties. Even in Sir Ganga Ram Hospital another debridement was done on 21.12.2011, which was followed by TKR revision Stage-II on 25.4.2012. It is further averred that TKR surgery was conducted in opposite parties Nos.1 to 3-Hospital by opposite party No.4 and after more than two months of the surgery the complainant developed cellulitis for which she was immediately put on antibiotic. As it evolved into a soft tissue abscess I&D procedure was also conducted. As the knee joint was involved/infected the prosthesis of complainant was removed and antibiotic spacer was placed. Therefore, a known and established procedure was followed. There was no deviation whatsoever in the procedure conducted and it is also not the case of the complainant that there was any deviation whatsoever. It is further averred that Dr. Harsimran Singh-opposite party No.4 is a Graduate of All India Institute of Medical Sciences and he has done his Post Graduation in MS Ortho from PGIMER, Chandigarh. He has done his M.Ch. (Ortho) from University of Dundee, Scotlant, U.K. He has performed over 4300 joint replacement surgeries in Fortis Hospital, Mohali over the past five and a half years. Dr. Atual Joshi-opposite party No.5 is MS (PGI) and Fellow Minimal Access Surgery. Thus, both opposite parties Nos.4 and 5 are well qualified in their respective fields. Reference to a number of judgments of Hon'ble Supreme Court and Hon'ble National Commission has been made. On merits, the admission of the complainant in opposite parties Nos.1 to 3-Hospital and her treatment by opposite parties Nos.4 and 5 has been admitted. It is averred that a knee replacement surgery is amongst the most successful of all orthopaedic procedures. It has proven to significantly enhance the quality of an arthritis patient. However, a number of possible complications have been well defined in the medical literature including but not limited to infection. The metallic implant that is inserted can become a focus of infection either soon after surgery or within period of months or years thereafter for any reason. The risk of such an event varies between 0.5% and 2% in most medical series. Therefore, TKR comes with its own set of complications. Opposite parties Nos.4 and 5 did everything that would be expected from a medical professional in trying to contain the soft tissue infection. Even in the most developed countries of the West which have inherently low bacterial flora in the environment, infection after TKR is a well known and well accepted complication. In own series of over 4300 joint replacements performed by opposite party No.4 over the period of 5 years infection rate has been less than 1%. Merely occurrence of a known complication after knee replacement cannot be construed as negligence. All the averments made in the preliminary objections have been reiterated. Denying the other averments of the complaint and denying any deficiency in service and medical negligence on the part of the opposite parties a prayer for dismissal of the complaint was made.