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Device malfunction.Ambulating using a walker.Bilateral knee pain.Spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection (unevaluable event).Case narrative: this unsolicited legal case from united states was received on (b)(6) 2018 from a physician.This case involves a (b)(6) female patient who received treatment with synvisc one and later after unknown latency ambulating using a walker, bilateral knee pain and spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection.Device malfunction was also reported with the lot number medical history was significant for hip degenerative joint disease, knee degenerative joint disease, appendectomy, c-section, left total hip replacement and hysterectomy.Concurrent condition included primary osteoarthritis of both knees.The patient drinks alcohol daily, never smoked tobacco.The patient was active with no formal exercise.Concomitant medications included carvedilol, gabapentin, levothyroxine sodium (levothyroxine), meloxicam, nabumetone, hydrocodone bitartrate/paracetamol (norco), tramadol hydrochloride (tramadol) and triamterene.Relevant past drug was not reported on (b)(6) 2017, the patient received treatment with intra-articular injection of synvisc one (dosing regimen: not reported; batch/lot number: 7rsl021 and expiry date: may-2020) in both knees for primary osteoarthritis of left knee and right knee.The risks, benefits and complications of injections were discussed with the patient.The patient understood, agreed and wished to proceed.Both of the patient's legs were prepped with betadine.Under sterile conditions an injection was given to each with a mixture of 2 cc of 1% lidocaine, 6 cc of 1% marcaine with epinephrine and 2 cc of depo-medrol.A sterile band-aid was placed over the injection site.The patient tolerated the procedure well.On (b)(6) 2017, patient presented for follow-up of the bilateral synvisc one injections given to her.She spent 3-1/2 days in the hospital because reaction to this particular lot of medication.The patient was better now.She was ambulating using a walker.The patient knew that ultimately she would benefit from total knee arthroplasty.It was also reported that the pain was improving in both knees secondary to reaction to the visco supplementation injection.Corrective treatment: methylprednisolone acetate (depo-medrol) for ambulating using a walker and bilateral knee pain.Outcome: recovering for all events (except for spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection).A pharmaceutical technical complaint was initiated with gptc number (b)(4).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 (b)(6) 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required hospitalization, disability and required intervention for device malfunction; disability and required intervention for ambulating using a walker; required intervention for bilateral knee pain; required hospitalization for spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection.Follow-up was received on 18-may-2018.Gptc number was added.
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Device malfunction [device malfunction]; ambulating using a walker [walker user]; bilateral knee pain [knee pain]; spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection [unevaluable event].Case narrative: this case is cross linked with case id: (b)(4) (cluster) this unsolicited legal case from united states was received on 10-may-2018 from a physician.This case involves a 71 year old female patient who received treatment with synvisc one and later after unknown latency ambulating using a walker, bilateral knee pain and spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection.Device malfunction was also reported with the lot number the patient's past medical history included arthropathy on (b)(6) 2014, osteoarthritis on 09-(b)(6) 2015 with (b)(6) 2014 and (b)(6) 2015, appendicectomy in (b)(6) 1978, caesarean section in (b)(6) 1975 with and 1979, hip arthroplasty in jun-1975 with and 1979, hysterectomy in(b)(6) 2009, colonoscopy on (b)(6) 2017, atrial fibrillation with on chronic aspirin, non-tobacco user, limb discomfort with discomfort down toward her groin, mobility decreased, gait disturbance, patellofemoral pain syndrome, joint effusion, thyroid disorder, nausea, physiotherapy, heart rate irregular, arthralgia on (b)(6) 2017, walking aid user on (b)(6) 2017, hypothyroidism, tetanus immunization in 2016, osteomyelitis, mitral valve incompetence with mild- per echo, menopausal symptoms, foot operation in (b)(6) 2012, non-tobacco user, arthralgia, cerebrovascular accident, hyperlipidemia, dysphonia on 10-(b)(6) 2017, grade b esophagitis on (b)(6) 2017 with was seen starting at 39 cm from the incisors in the lower third of the esophagus and gastroesophageal junction, compatible with erosive distal esophagitis., mucosal erosion on (b)(6) 2017 with erythema and congestion of the mucosa and were compatible with gastritis and stomach mucosal erythema on (b)(6) 2017.The patient's past medical treatment included codine linctus and synvisc one on (b)(6) 2015 and (b)(6) 2018.The patient's family history included blood pressure increased, neoplasm malignant, cardiac disorder, leukaemia, coronary artery disease, myocardial infarction and pneumonia.The patient's past vaccination of tetanus toxoid in 2016.At the time of the event, the patient had ongoing osteoarthritis on (b)(6) 2016 with intermittent, using resistance band, steroids and physical therapy and alcohol use.Family history included: cancer in mother, heart disease in father and high blood pressure in father on (b)(6) 2017, the patient received treatment with intra-articular injection of synvisc one (dosing regimen: not reported; batch/lot number: 7rsl021 and expiry date: may-2020) in both knees for primary osteoarthritis of left knee and right knee.The risks, benefits and complications of injections were discussed with the patient.The patient understood, agreed and wished to proceed.Both of the patient's legs were prepped with betadine.Under sterile conditions an injection was given to each with a mixture of 2 cc of 1% lidocaine, 6 cc of 1% marcaine with epinephrine and 2 cc of depo-medrol.A sterile band-aid was placed over the injection site.The patient tolerated the procedure well.On (b)(6) 2017, patient presented for follow-up of the bilateral synvisc one injections given to her.She spent 3-1/2 days in the hospital because reaction to this particular lot of medication.The patient was better now.She was ambulating using a walker.The patient knew that ultimately she would benefit from total knee arthroplasty.It was also reported that the pain was improving in both knees secondary to reaction to the visco supplementation injection.On (b)(6) 2018, patient reported to the clinic again regarding her bilateral knee pain.Both the legs of the patient were prepped with betadine and an injection was administered which was a mixture of 2cc of 1% lidocaine, 6cc of 1% marcaine with epinephrine and 2cc of depo medrol.On (b)(6) 2018, the patient again received depo medrol 40 mg injection in both knees.On (b)(6) 2018, patient received another steroid injection for bilateral knee pain and tolerated the procedure well.On (b)(6) 2018, the patient reported to the clinic again with the complaint of bilateral knee pain.The patient received another synvisc-one injection (lot 7rsl047, exp 31-oct-2020).Both of the patient's legs were prepped with betadine.Under sterile conditions, an injection was given into both knees with synvisc one.Sterile band-aid were placed over the injection sites.The patient tolerated the procedure well.Corrective treatment: methylprednisolone acetate (depo-medrol) for ambulating using a walker and bilateral knee pain outcome: recovering for all events (except for spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection).A pharmaceutical technical complaint was initiated with gptc number (b)(4).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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required hospitalization, disability and required intervention for device malfunction; disability and required intervention for ambulating using a walker; required intervention for bilateral knee pain; required hospitalization for spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection follow-up was received on 18-may-2018.Gptc number was added.Additional information was received on 07-aug-2018 from healthcare professional.Medical history was added.Clinical course was updated and text was amended accordingly.Additional information received on 07-aug-2018 from healthcare professional.Past surgical procedure of colonoscopy and past drug of synvisc one added.Clinical details of patients visits on (b)(6) 2018 added.Clinical course updated.Text amended accordingly.
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