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Ambulation with assistive device [walking aid user] ; synovial reaction/ inflammatory process [inflammatory reaction] ([synovial fluid white blood cells positive], [synovial fluid analysis abnormal], [knee pain], [condition worsened], [knee effusion], [knee swelling]); device malfunction [device malfunction] ; fell [fall] ; soft tissue swelling [soft tissue swelling] ; difficulty walking/ notable limp [walking difficulty] ; ankle injury/ sprain of tibiofibular ligament of right ankle [ankle injury] ; lower extremity swelling [peripheral swelling] ; lower extremity pain/ lower foot pain [pain in extremity] ; not had relief since the injection [device ineffective].Case narrative: initial information received on (b)(6) 2018 regarding an unsolicited valid serious legal case from united states received from a consumer/non-hcp.This case involves a (b)(6) female patient who experienced ambulation with assistive device(latency: 10 days), synovial reaction/ inflammatory process (latency: 10 days),device malfunction, fell (few days), lower extremity swelling (latency: 10 days), not had relief since the injection(latency: 10 days), notable limp (latency: 17 days) walking difficulty, ankle injury./ sprain of tibiofibular ligament of right ankle, soft tissue swelling (latency: 1month 27 days) with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included cirrhosis of liver, diabetes mellitus, enlarge spleen, hypertension, osteoarthritis, thrombocytopenia, repair foot in 1968, back surgery, carpal tunnel release, caesarean section, drug allergy to sulfa , arthritis, severe liver failure, arthrocentesis and former smoker.The patient's family history included dementia alzheimer's type with father and mother.The patient's past medical treatment(s), vaccination(s) was not provided.Concomitant medications included hydrocodone for pain; acetaminophen for pain; bumetanide; insulin glargine (lantus); insulin lispro (humalog); amiloride; salbutamol sulfate (ventolin hfa), albuterol sulfate, lisinopril, zyrtec, a87, nebifiber, metformin, cinnamal and trijenta.On (b)(6) 2017, the patient was administered synvisc one (hylan g-f 20, sodium hyaluronate), intra-articular injection of 6ml dosage ,1x frequency (lot - 7rsl021) for primary osteoarthritis of bilateral knees.On (b)(6) 2017, lab results of the patient revealed mean cell volume was 96.2 (high), mean cell hemoglobin 32.5 (high), platelet count 65 (low), mean platelet volume was 12.9 (high), lymphocyte count 18.8 (low), c reactive protein was 1.23 (high), fluid wbc 15096 (high).On (b)(6) 2017, patient reported of knee pain that had significantly increased following her bilateral knee synvisc on injections.Also, she reported increasing pain and swelling after recent synvisc injections given 2 weeks ago.She had not had relief since the injection and also felt that her pain was worsened.Cell count in the left knee was 15000 which represented an inflammatory process.Patient was given a prescription of volaren 75 mg and use of ice was encouraged.Also, it was reported that the patient had lower extremity swelling and left knee showed moderate effusion.On (b)(6) 2017, patient reported that her problem was unchanged, she stated that she continued to have pain and that was slowly resolving.Her cultures were negative till date.Patient had a notable limp.On (b)(6) 2017, x-ray knee revealed tricompartmental degenerative joint disease with varus deformity.On (b)(6) 2018, patient reported taht she had fallen 1 week ago and had some residual ankle pain requiring the use of crutches.Pt complained of right foot pain which occurred due to the fall.Patient stated that she had pain since her fall and had difficulty walking.She stated that her knee pain was directly attributable to her recent ankle injury/ sprain of tibiofibular ligament of right ankle.She reported she was more mobile now and had resumed the use of cane.Patient was poorly ambulated limited by lower extremity pain and swelling.X-ray report of foot revealed mild degenerative changes.The physician reported that the possibility of occult infection from this unusual organism noted in the documentation could not be excluded.Also, the physician reported that the patient had considerable soft tissue swelling but some of this was from fluid retention associated with end-stage liver disease.X-ray report of ankle revealed calcification of the calcaneus consistent with long standing plantar fascitis.On (b)(6) 2018, patient reported that no improvement was seen and she was ambulating with a cane.Also, it was reported that the patient was not interested in steroid injection and her lower extremity swelling and edema had mildly improved.On (b)(6) 2018, patient reported that her bilateral knee pain had increased.It was reported that a bilateral knee steroid injection was given after risks and benefits were discussed with the patient.Site was prepped with povidone iodine and alcohol.Left knee medial joint line injection was performed with 4 ml of lidocaine 1% plain for anesthetic.Placement was confirmed with manual palpation.Dexamethasone 8 mg was injected and adhesive sterile dressing was used.Corrective treatment: the patient was treated with diclofenac potassium (voltaren acti) for synovial reaction/ inflammatory process; crutches and cane for ambulation with assistive device.Seriousness criteria: disability for ambulation with assistive device and fell, intervention required for synovial reaction/ inflammatory process.Outcome: recovering / resolving for fell; not recovered for ambulation with assistive device, synovial reaction/ inflammatory process, difficulty walking, device malfunction; unknown for rest o fthe vents.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.
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