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Device malfunction [device malfunction].Pain in his knee/pain/chronic progressive right knee pain [knee pain].Swelling in his knee/right knee swelling [knee swelling].Numbness in his foot/numbness sensation of face, mouth ears [numbness].Blood pressure elevated/ blood pressure low/blood pressure fluctuation [blood pressure fluctuation].Tingling sensation of the face, mouth, ears [tingling sensation].Flexion to 90 degrees [joint range of motion decreased].Issues with hip [joint disorder nos].Cold symptoms [cold symptoms].Knee was hot/warmth of right knee [joint warmth].Case narrative: based on the additional information received on 13-sep-2018 form patient the case has been upgraded from non serious to serious due to addition of seriousness criteria of intervention required for event pain in his knee/pain/chronic progressive right knee pain and swelling in his knee/right knee swelling.This unsolicited valid serious malfunction case from united states was received on 15-jan-2018 from a patient.This case concerns a male patient of unknown age who received treatment with synvisc one and later after unknown latency had device malfunction, pain in his knee/ pain/ chronic progressive right knee pain, numbness in his foot/numbness sensation of face, mouth ears, blood pressure elevated/ blood pressure low/blood pressure fluctuation, tingling sensation of the face, mouth, ears, flexion to 90 degrees, issues with hip, knee was hot/warmth of right knee, cold symptoms and swelling in his knee/right knee swelling.The patient's past medical history included hypertension, joint surgery, knee operation, tonsillectomy, renal disorder, seasonal allergy, sinus congestion, tobacco user, arthralgia, pain, chondromalacia, joint swelling in (b)(6) 2017, gait disturbance in (b)(6) 2017, synovial cyst in (b)(6) 2017, joint stiffness in (b)(6) 2017, arthroscopy in (b)(6) 2017, gait disturbance in (b)(6) 2017, pain in (b)(6) 2017, productive cough and hernia.The patient's family history included neoplasm malignant, diabetes mellitus, cardiac disorder, lung neoplasm malignant and cerebrovascular accident.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing arthralgia, alcohol use, meniscus injury, osteoarthritis in (b)(6) 2017, insomnia and hypoaesthesia.Notes: the patient was not allergic to avian products, feathers or egg products.Concomitant medications included amitriptyline for alcoholism; and multivitamins nos.On (b)(6) 2017, after educating the patient and receiving consent for procedure, chlorapep was used and the joint space was injected with intra-articular synvisc one injection with a dosage of 48 mg (6 ml) (batch/lot number: unknown) for primary osteoarthritis of right knee.On the same day, patient had no swelling, limping gait, ecchymosis, atrophy and had neutral alignment with weight bearing.Further patient presented tenderness at medial joint line and lateral joint line with no patellar tendon tenderness and no pain of medial, and lateral collateral ligament (mcl and lcl) with full extension and flexion range of motion and strength.Patient had full sensation, dorsal pedal pulse 2+ and posterior tibialis pulse 2+.Patient had an injection in october, which was with the recalled synvisc.He reported that his knee improved for a couple of weeks after this injection.On an unknown date in 2017, (a week or 2 later after the injections) after few days, the patient experienced pain and swelling in his knee.On an unknown date in 2017, after unknown latency, the patient's knee was hot and had some cold symptoms.He did see his medical doctor.Mri was done and was given prednisone and referred to his orthopedic doctor for acl.The patient would be seeing his orthopedic doctor soon.No further information was provided.Patient presented with chronic progressive right knee pain.Further patient reported that pain was 7 out of 10 associated with swelling and warmth of right knee.Patient had been taking tramadol as needed.Nsaids were limited sut to kidney problem.He had injection in his knee that helped for a couple of weeks and pain returned.On an unknown date, after synvisc one administration, patient had flexion to 90 degrees.On (b)(6) 2018, patient followed up for right knee pain.An mri was done that showed 1.2x1.8 cm focus of subchondral edema and cystic changes within the medial femoral condyle adjacent to the intercondylar notch corresponding to a similar sized focus of moderate grade chondromalacia.No full thickness or cartilage defect noted.Morphologic changes medial meniscus compatible with a partial meniscectomy.Irregularity and signal abnormality in the posterior horn meniscai remnant could represent a small remnant of the original tear or possibly a small recurrent tear within the posterior hom meniscai remnant.No large tear or displaced meniscal fragment.Severe musinous degeneration of the acl with a large pericruciate ganglion cyst posterior to intercondylar notch.Patient stated that his knee had been better.He doesn't feel his knee had become unstable, but he was having more pain.On an unknown date in (b)(6) 2018, after few months latency, the patient had numbness and tingling sensation in his foot, face, mouth and ears.He did not have any temperature.Patient reported that patient still had right chronic knee pain.He was ready for a second opinion.The knee has reduced his quality in terms of activity and his daily functions.On (b)(6) 2018, after 4 months 2 days latency, patient's blood pressure has been fluctuating shortly after med adjustments, on last visit toe losartan was increased to 50 bid nd atenolol 25 mg daily was added.However, over toe next few days after the increased dosage, the bp seemed to get worse, and in the 150s-170s, over 105.So he went to ed, and testing of heart.Ekg/troponins did not show any acute coronary event.He was told to follow up with pcp.Patient noticed about 2 days later that bp began to drop too low in the 80s over 50s.So he stopped the atenolol and cut back to one losartan daily.On (b)(6) 2018, the bp in clinic was in toe 122s/70s.On an unknown date in (b)(6) 2018, patient experienced issues with hip due to guarding toe knees.Relevant laboratory test results included: albumin globulin ratio (1.4 - 2.6 %) - on (b)(6) 2017: 1.1 %.Blood alkaline phosphatase (56 - 155 u/l) - on (b)(6) 2017: 33 u/l; on (b)(6) 2018: 25 u/l.Blood chloride (99 - 111 mmol/l) - on (b)(6) 2017: 94 mmol/l; on (b)(6) 2018: 96 mmol/l.Blood cholesterol (107 - 200 mg/dl) - on (b)(6) 2017: 203 mg/dl.Blood creatinine (0.70 - 1.20 mg/dl) - on (b)(6) 2017: 1.24 mg/dl; on (b)(6) 2018: 1.22 mg/dl.Blood glucose (70 - 99 mg/dl) - on (b)(6) 2017: 120 mg/dl; on (b)(6) 2018: 124 mg/dl.Blood pressure measurement - on (b)(6) 2018: 144/82 mmhg; on (b)(6) 2018: 80s over 50s mmhg; on (b)(6) 2018: 120/70 mmhg.Blood triglycerides (40 - 150 mg/dl) - on (b)(6) 2017: 181 mg/dl.Globulin (2.0 - 3.5 g/dl) - on (b)(6) 2017: 3.6 g/dl.Glycosylated haemoglobin (3.5 - 5.7 %) - on (b)(6) 2017: 6 %.Low density lipoprotein (70 - 100 mg/dl) - on (b)(6) 2017: 118 mg/dl.Mean cell haemoglobin (27 - 31 pg) - on (b)(6) 2017: 33.3 pg; on (b)(6) 2018: 34.3 pg.Mean cell haemoglobin concentration (33 - 37 %) - on (b)(6) 2017: 32.9 %; on (b)(6) 2018: 34.1 %.Mean cell volume (80 - 96 fl) - on (b)(6) 2017: 101 fl; on (b)(6) 2018: 101 fl.Mean platelet volume (7.4 - 10.4 fl) - on (b)(6) 2017: 6.8 fl; on (b)(6) 2018: 7 fl.Microalbuminuria (0 - 2.Mg/l) - on (b)(6) 2017: 25.1 mg/l.Monocyte percentage (3 - 10 %) - on (b)(6) 2018: 11.9 %.Nuclear magnetic resonance imaging - on (b)(6) 2018: abnormal unk [irregularity and sign.Abnormality in posterior horn meniscal remnant].Urine leukocyte esterase - on (b)(6) 2017: trace unk.Vitamin b6 (5.3 - 46.7 ug/l) - on (b)(6) 2018: 95.6 ug/l.(other relevant tests included microalbumin/ creatinine ratio: 25.1 (high) reference range 0 to 25 mg/g).Final diagnosis was swelling in his knee/right knee swelling, knee was hot/warmth of right knee, tingling sensation of the face, mouth, ears, numbness in his foot/numbness sensation of face, mouth ears, blood pressure elevated/ blood pressure low/blood pressure fluctuation, cold symptoms, flexion to 90 degrees, pain in his knee/pain/chronic progressive right knee pain and device malfunction.Corrective treatment: prednisone, methylprednisolone acetate (depomedrol) for arthralgia, lidocaine and tramadol for pain in his knee/pain/chronic progressive knee pain and device malfunction; and prednisone for swelling in his knee/right knee swelling; losartan and atenolol for blood pressure elevated/ blood pressure low/blood pressure fluctuation; not reported for rest of the events.The patient outcome is reported as recovering / resolving for numbness in his foot/numbness sensation of face, mouth ears, as unknown for knee was hot/warmth of right knee, as unknown for cold symptoms, as not recovered / not resolved on an unknown date for pain in his knee/pain/chronic progressive right knee pain, as not recovered / not resolved on an unknown date for swelling in his knee/right knee swelling, as unknown for flexion to 90 degrees, as recovering / resolving for tingling sensation of the face, mouth, ears, as recovered / resolved on (b)(6) 2018 for blood pressure elevated/ blood pressure low/blood pressure fluctuation and as not recovered / not resolved on an unknown date for device malfunction.Seriousness criteria: required intervention for device malfunction, pain in his knee/pain/chronic progressive right knee pain and swelling in his knee/right knee swelling.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.A global pharmaceutical technical complaint was initiated and ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is 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 has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information was received on 01-mar-2018.The gptc number with ptc results were added.Text was amended accordingly.Additional information received on 13-sep-2018 from non-health care professional.Patient's medical history, concomitant medication added.Event verbatim updated for all events.Additional event of device malfunction, blood pressure elevated/ blood pressure low/blood pressure fluctuation, flexion to 90 degrees, tingling sensation of the face, mouth, ears added.Seriousness criteria of pain in his knee/pain/chronic progressive right knee pain and swelling in his knee/right knee swelling was added.Clinical course was updated and text amended accordingly.
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