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Gait was antalgic on the left with a cane/moved very slowly while walking [antalgic gait].Synovitis/inflammatory flare [synovitis] ([arthralgia aggravated], [joint warmth], [effusion (l) knee], [synovial fluid analysis abnormal]).Left total knee arthroplasty [knee arthroplasty].Injured by synvisc one [injury nos].Still had pain with standing/felt worse with standing after sitting/hurt to get up from sitting [difficulty in standing].Crepitus was palpable [joint crepitation].Hurt to get up from sitting and to apply weight for left leg [weight bearing difficulty].Case narrative: based upon additional information received on 21-oct-2019, this case initially assessed as non serious was upgraded to serious as following events were added in to the case synovitis/inflammatory flare, (disability and intervention required), left total knee arthroplasty (medically significant), gait was antalgic on the left with a cane/moved very slowly while walking (caused disability).This case was linked to case (b)(4) (same patient, multiple devices), (b)(4) (duplicate).Initial information received on 20-feb-2018 from united states regarding an unsolicited valid legal serious case received from a lawyer.This case involves a (b)(6) female patient (165.1 cm and 91.17 kg) who experienced synovitis/inflammatory flare (latency: unknown), left total knee arthroplasty (latency: 11 months 24 days), injured by synvisc one (latency: unknown), crepitus was palpable (latency: 6 months 15 days), still had pain with standing/felt worse with standing after sitting/hurt to get up from sitting (latency: 9 months 11 days), gait was antalgic on the left with a cane/moved very slowly while walking, hurt to get up from sitting and to apply weight for left leg (few months) while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included fall in (b)(6) 2011, high cholesterol, cardiovascular edema, chronic hypertension, vitamin d deficiency, advanced tricompartmental osteoarthritis, arthritis, toe joint pain, left, d & c surgery in 1996 and poor circulation.The patient's family history included hypertension (mother) and stroke (mother).At the time of the event, the patient had ongoing chronic knee pain, stiffness, right knee arthritis, cataract, uses glasses/contacts.Patient never smoked and was a nondrinker.The patient's past medical treatment(s), vaccination(s) was not provided.Patient had no known drug allergies.Patient had 2 previous pregnancies.Patient did not use any drugs or caffeine.Oral nsaids were contraindicated due to elevated bp.Concomitant medications included ergocalciferol; diclofenac (voltaren); verapamil hcl; fish oil concentrate; cyanocobalamin (vitamin b 12); benazepril hcl, estradiol; and sertraline hcl.Upon examination on the day of injection (02-nov-2017), patient's left knee was stiff, had pain (sharp and stinging), morning stiffness (5-10 min) knee appeared boggy and patient had difficulty with range of motion.On (b)(6) 2017, patient received intra-articular injection of hylan g-f 20, sodium hyaluronate, frequency once (dose, batch: unknown) (there would be no information on batch number for this case) for primary osteoarthritis of left knee.After the patient informed consent, left knee was injected with hylan g-f 20, sodium hyaluronate, under sterile conditions with local anesthesia and 26 cc of clear yellow fluid was aspirated.The patient tolerated the procedure well with no immediate complications.Lab tests analysis done for aspirated synovial fluid showed nucleated cells as 745 cells/ul (high) (0-200).On (b)(6) 2017, patient reported to the clinic and mentioned she had worsening left knee pain (latency: 5 days), which was discussed with her doctor as most likely reaction to the injection.This event was assessed as serious and required intervention.As a corrective treatment, patient received medrol dose pack.There was no warmth, redness, fever or swelling and it was not much painful when she sat.The patient was told to follow up the same week to be evaluated and was advised to call ems if she could not get out of her house in 1 to 2 days.On (b)(6) 2017, patient reported for follow up visit and described her knee pain as sharp and said it was worsening.Patient did not have morning stiffness, no joint redness or stiffness.Upon examination, mild warmth (latency: 7 days) with no fever or redness was noted.The patient reported she did experience some relief with the medrol dose pack.The patient was told to discontinue medrol and was put on low dose of tramadol.The same day, patient's knee was aspirated with 34 cc of hazy yellow fluid and a kenalog injection was given under sterile conditions with local anesthesia.Patient tolerated the procedure well and was advised to rest for 48-72 hours and call back next week if she still did not feel better.Patient also had her synovial fluid culture performed which revealed nucleated cells in the synovial fluid as 20950 cell/ul (high) (reference range: 0-200), synovial fluid was cloudy (reference range: clear) and fluid culture was sterile.On an unknown date in (b)(6) 2017, patient had developed synovitis (latency: unknown, caused disability, required intervention) after her injection which improved after cortisone injection.This event was assessed as serious and required intervention.On an unknown date in 2017, the patient was injured with synvisc one (latency: unknown).It was reported that the patient was not yet pressing a law suit, it would depend on if it was a bad batch.On (b)(6) 2018, patient reported for her follow up visit.Upon examination of her left knee, no warmth and no tenderness on palpation was noted.On (b)(6) 2018, the x-ray imaging studies of the patient revealed both knees showed severe bone on bone degenerative changes, worse on the left knee.On (b)(6) 2018, patient reported for follow up of her left knee pain and stiffness.The patient reported she developed severe left knee pain after her gel one injection by her rheumatologist 6 months ago, she had an inflammatory flare after the gel one injection and was in a wheelchair.She used a cane, but her left knee pain was severe.She moved very slowly while walking.It hurt to get up from sitting and to apply weight for left leg.She described her left knee pain as severe and sharp.The patient had 5 mri studies of her left knee which revealed severe osteoarthritis.Patient appeared to be well developed, well nourished, oriented and in no acute distress.The patient's gait was antalgic on the left with a cane (caused disability).Upon examination, left knee showed alignment of the knee was mild varus, flexion contracture of 20 degrees, palpation showed medial joint line tenderness present, decreased range of motion, crepitus was palpable (latency: 6 months 15 days), positive patella grind test, negative mcmurray and lachmans sign, no effusion, no erythema or instability.The right knee did not show any tenderness on palpation, effusion, erythema or any instability.The patient was advised that it was not unusual for her viscosupplementation to not be effective as she had severe arthritis and conservative treatments may no longer be very effective and was recommended to undergo total knee replacement.The same day, patient was injected depomedrol into her left knee, under sterile conditions.Patient was advised to refrain from strenuous activities for 2-3 days and to apply ice twice a day for 10 minutes.Patient was instructed to follow up in 6 weeks.On (b)(6) 2018, patient reported for her 6 weeks follow up and reported her knees were still and so far nothing had helped.Upon examination, the left knee showed no evidence of instability, effusion or erythema, palpation showed medial joint line tenderness, crepitus was palpable, negative mcmurray and lachman signs.Patient got 3 weeks of relief with the corticosteroid.It was more stiffness than pain.She was trying to avoid joint replacement surgery.On (b)(6) 2018, patient visited the clinic and complained that her knees are very still especially left one and she walked with a cane.The patient reported that her aqua therapy helped her with stiffness, and she could walk a little further now.Patient still had pain with standing (latency: 9 months 11 days) and initiating walking and reported it was quite sharp.Upon examination, the left knee still had decreased range of motion which was present prior the injection as well, crepitus was palpable, and no erythema or effusion was noted.The patient's treatment plan was renewed for aqua therapy.On (b)(6) 2018, patient reported for follow up of her knee arthritis and rated her left knee pain at 10 on a scale of 10 at its worst and stated it was sharp in character.Currently, as a corrective treatment, patient was on motrin and rest.She said she felt worse with standing after sitting.The patient had exhausted all conservative measures, including activity modifications, pain medications, ambulatory aids, physical therapy modalities and injections and was therefore advised to undergo left total knee arthroplasty.On (b)(6) 2018, patient underwent left total knee arthroplasty (latency: 11 months 24 days, assessed as medically significant) with orthoalign computer assisted surgery as she had end stage degenerative arthritis left knee.The patient had not undergone any surgical knee procedures in the past.The patient was given spinal anesthesia, following which left leg was prepped and draped free after a tourniquet had been applied to the thigh.The midline approach was done, followed by a medial parapatellar arthrotomy.The degenerative osteophytes, menisci and cruciate ligaments were taken down.Orthoalign computer assisted surgical technique was used to minimize bone resection, tissue dissection, bleeding and intramedullary drilling.Care was taken to ensure proper alignment of all components.A patellar reamer was used to cut the patella such that the bone implant composite matched the original thickness of the patella.All the trials were inserted and appropriate sized polyethylene trial was also inserted.The knee was taken through a range of motion.There was excellent stability throughout a full arc of motion following which trials were removed and actual components were then cemented in.The tourniquet was let down, electrocautery and aquamantis were used to control bleeding.The knee was infiltrated locally and deep with anesthetic.The wound was copiously irrigated and closed in a layered manner over a reinfusion drain, including rigid repair of extensor mechanism.A dry, sterile pressure dressing was applied and patient was sent for recovery.On (b)(6) 2018, the patient was discharged.On (b)(6) 2018, patient reported for evaluation, two weeks after her arthroplasty.Patient had her staples removed and was feeling better.The symptoms were diffuse and did not radiate, which included pain, mild tenderness to palpitation, improved rom, improved strength, instability, moderate swelling and stiffness.The events were assessed as serious and were leading to disability.As a corrective, patient was taking tylenol, using a cane and rest.Patient reported that the symptoms occurred intermittently.Upon examination, the incision appeared clean, dry, intact and was healing well.Patient had mildly antalgic gait.This event was assessed as serious and was leading to disability.The patient was recommended physical therapy and was told to follow up after four weeks or as needed.On (b)(6) 2019, patient reported for follow up post knee replacement.She had improved 90%.Patient still had pain, swelling and felt worse with flexion of knee, climbing stairs and walking.This event was assessed as serious and was leading to disability.The patient was not taking any medications and was just using a cane, rest and performing restricted activity.Patient described the quality of her symptoms as mild to moderate.Physical therapy was continued.On (b)(6) 2019, patient reported for after care visit and mentioned she still had pain and swelling.Patient still used cane and stated that she felt worse with flexion of knee, climbing stairs and walking.Patient mentioned her physical therapy was going well.On (b)(6) 2019, at her follow up visit, patient complained of left hip pain.Which was caused by the patient climbing into a high vehicle, which occurred four weeks ago.The pain radiated to the posterior thigh and left buttock and reported it was worse with sitting.The patient was not taking any medication for pain relief.She was performing restricted activity and rest.Patient denied numbness or tingling.The patient stated that her left knee was doing well after the surgery with only minor discomfort to anterolateral aspect intermittently.As a corrective treatment for her hip pain, patient was started on home exercise program.The activity modifications were reviewed, and medication were discussed.On (b)(6) 2019, patient reported for her aftercare visit following left knee surgery.She had improved by 97%.The patient denied pain in her left knee.The patient was no longer undergoing physical therapy and was not taking any pain medications.The patient's incision appeared clean, intact, there was mild tenderness on palpation, moderate swelling, improved strength and range of motion and mild antalgic gait.The treatment plan was to continue with strengthening and range of motion exercises with full weightbearing and knee arthroplasty instructions.Action taken: not applicable for all the events.Corrective treatment: medrol dose pack, tramadol, physical therapy, kenalog, depomedrol, motrin, rest, tylenol, cane, cortisone for synovitis/inflammatory flare; physical therapy, cane, wheelchair for gait was antalgic on the left with a cane/moved very slowly while walking; not reported for rest of the events.Outcome: unknown for hurt to get up from sitting and to apply weight for left leg, crepitus was palpable, still had pain with standing/felt worse with standing after sitting/hurt to get up from sitting, injured by synvisc one; recovering for synovitis/inflammatory flare, gait was antalgic on the left with a cane/moved very slowly while walking and left total knee arthroplasty.A product technical complaint (ptc) was initiated on (b)(6) 2018 for lot number: unknown with global ptc number: 52777.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Date of completion: 28-feb-2018.Additional information was received on 28-feb-2018.Batch lot number was updated.Ptc investigation results were added.Additional information received on 21-oct-2019 from lawyer.Case upgraded to serious and classification of legal case added.Related case id added.Patient demographics updated.The medical history of fall, high cholesterol, cardiovascular edema, vitamin d deficiency, advanced tricompartmental osteoarthritis, arthritis, toe joint pain, left, d & c surgery and poor circulation added.The patient's family history of hypertension and stroke added.Concurrent conditions of chronic knee pain, stiffness, never smoked and nondrinker added.Suspect product therapy dates with details added.Concomitant medications of ergocalciferol, voltaren, verapamil hcl, fish oil, vitamin b12, benazepril, estradiol and sertraline added.Events of synovitis/inflammatory flare (symptoms- worsening knee pain/knee pain as sharp/medial joint line tenderness, mild warmth, knee was aspirated with 34 cc of hazy yellow fluid), crepitus was palpable, still had pain with standing/felt worse with standing after sitting, gait was antalgic on the left with a cane/moved very slowly while walking, hurt to get up from sitting and to apply weight for left leg were added.Clinical course updated.Text amended accordingly.
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