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This case is cross referenced with case: (b)(4).This unsolicited case from united states was received on 30-nov-2017 from a nurse.This case concerns an (b)(6) male patient who received treatment with synvisc one and later after unknown latency had swelling, pain and aspiration of fluid, also, device malfunction was identified for the reported lot number.No medical history, concomitant medication or concurrent condition was provided.The patient had past treatment with synvisc one.On an unknown date, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml (frequency and indication: unknown) (batch/lot number: 7rsl021; expiry date: 31-may-2020).On an unknown date in (b)(6) 2017, after unknown latency, the patient had swelling and pain.It was reported that aspiration of fluid was done (event onset date and latency: unknown) and steroid injection was given.Corrective treatment: steroid injection for pain and swelling; aspiration and steroid injection for aspiration of fluid; not reported for device malfunction outcome: unknown for all the events seriousness criteria: required intervention for all the events a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.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 follow up was received on 29-nov-2017.The date of birth was corrected from (b)(6).Expiration date was added.Patient's age was added.No significant information was received.Additional information was received on 30-nov-2017.An additional event of device malfunction was added with details.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 30-nov-2017: this case concerns a male patient who received synvisc one injection from the recalled lot and later developed pain, swelling and aspiration of fluid.As the concerned lot number has been identified to have malfunction by the company, the causal relationship of suspect product cannot be ruled out with the occurrence of adverse events.
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Device malfunction [device malfunction].Pseudoseptic reaction [pseudosepsis] ([knee swelling], [knee pain], [knee effusion].[synovial fluid analysis abnormal]).Type 2 diabetes mellitus [type 2 diabetes mellitus].Discomfort particularly in right knee / medial discomfort [discomfort in joints].Weight bearing difficulty [weight bearing difficulty].Difficulty flexing [joint range of motion decreased].Joint crepitation / peripatellar clicks [joint crepitation].Shortness of breath [shortness of breath].Bruises/bleeds easily [bruising].Dyslipidemia [dyslipidemia].Erectile dysfunction [erectile dysfunction].Knee stiffness [joint stiffness].Case narrative: based on information received on 07-feb-2019, the case was classified as legal case.This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 30-nov-2017 from a nurse.This case concerns a 68 year old male patient who received treatment with synvisc one and later had pseudosepsis (latency: same day), type 2 diabetes mellitus also, discomfort particularly in right knee / medial discomfort(latency: same day), weight bearing difficulty(latency: same day), difficulty flexing(latency: same day), joint crepitation / peripatellar clicks (latency: same day), shortness of breath(latency: 4months), bruises/bleeds easily, dyslipidemia, erectile dysfunction, knee stiffness(latencies: unknown).Device malfunction was identified for the reported lot number.Patient's past medical history included chest pain, deviated septum, facial fractures resulting from mva, gout, right coronary artery stent placement, acute inferior wall myocardial infarction, hyperlipemia, hypertension, hypothyroid, obese, swelling of joint, wears dentures, lumbar fusion, refractive surgery, heart catheterization, arthrotomy, open repair meniscus, colonoscopy screening, former smoker and alcohol use.Patient had a family history of cancer and heart disease (mother).Patient reported of having synvisc injections in the past on (b)(6) 2016 and on (b)(6) 2017).Concomitant medications included allopurinol (zyloprim); aspirin [acetylsalicylic acid]; atorvastatin; clopidogrel; levothyroxine lisinopril ; metformin; metoprolol tartrate; acacia catechu wood, chondroitin sulfate; sodium, glucosamine hydrochloride, hyaluronic acid, maltodextrin, methylsulfonylmethane, scutellaria baicalensis root (glucosamine chondroitin advanced); omega-3-acid ethyl ester (lovaza); tadalafil; vitamins nos (theragran) ; tramadol (tramadol); clopidogrel bisulfate (plavix); fish oil (fish oil); atorvastatin calcium (lipitor); allopurinol (allopurinol); tramadol hydrochloride (ultram); and paracetamol (tylenol).On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml (batch/lot number: 7rsl021; expiry date: 31-may-2020) for osteoarthritis of knees, bilateral.On an unknown date in nov-17, after unknown latency, the patient had swelling and pain.It was reported that aspiration of fluid was done (event onset date and latency: unknown) and steroid injection was given.On (b)(6) 2017, patient noticed significant swelling, discomfort particularly in right knee.Patient was ambulating with crutches and had difficulty flexing and weight bearing.On (b)(6) 2017 , both the knees were aspirated and was given cortisone injections.The anterolateral aspect of bilateral knee was cleaned with chlorhexidine.Under sterile conditions, 2 cc of 1% lidocaine and 80 mg kenalog were injected.This was to reduce inflammation and pain and to restore functionality to the patient.Synovial fluid was cloudy and green tinged consistent with pseudo septic reaction.On (b)(6) 2018, lab results were, weightbearing xrays of right knee indicated mild progression of degenerative changes and for left knee indicated tricompartmental degenerative changes.Right knee showed 120 degrees of flexion and left knee showed 110 degrees of flexion and a prepatellar crepitus with medial joint line tenderness.On (b)(6) 2018, patient was positive for joint pain, shortness of breath, bruises/bleeds easily.On (b)(6) 2018, patient was given bilateral cortisone injections.He was scheduled to get euflexxa this spring due to previous reaction to synvisc.It was reported on (b)(6) 2018 , patient was given second euflexxa injections.Corrective treatment: steroid injection for pseudosepsis; euflexxa for knee stiffness; not reported for rest of the events.Outcome: unknown for all the events.Seriousness criteria: intervention required for device malfunction, pseudosepsis; medically significant for type 2 diabetes mellitus.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.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 follow up was received on 29-nov-2017.The date of birth was corrected from on (b)(6) 1949 to on (b)(6) 1949.Expiration date was added.Patients age was added.No significant information was received.Additional information was received on 30-nov-2017.An additional event of device malfunction was added with details.Clinical course was updated and text was amended accordingly.Follow up was received on 17-dec-2017.No new information was received.Additional information received on 07-feb-2019 from the non-healthcare professional.Additional events of pseudosepsis, type 2 diabetes mellitus also, discomfort particularly in right knee / medial discomfort,weight bearing difficulty, difficulty flexing, joint crepitation / peripatellar clicks , shortness of breath, bruises/bleeds easily, dyslipidemia, erectile dysfunction, knee stiffness were added with details.Medical history added.Concomitant medications were added.Clinical course was updated and text was amended accordingly.
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