| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Vertigo (2134); Dizziness (2194); Arthralgia (2355); Joint Swelling (2356); Numbness (2415); No Code Available (3191)
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| Event Date 12/12/2017 |
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Event Type
Injury
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Event Description
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Ambulating with walker [walking aid user].Numbness in right leg [numbness in leg].Pain in left leg [pain].Pain in knee as well as above and below [knee pain] ([condition worsened]).Swelling [knee swelling] ([condition worsened]).Case narrative: this case is cross referenced with case (b)(4) (same patient).Initial information received on 13-sep-2018 regarding an unsolicited valid serious case from united states received from a healthcare professional.This case involves a (b)(6) years old female patient who was ambulating with walked, had numbness in right leg, pain in left leg, experienced pain in knee as well as above and below, increased swelling, with the use of hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included tobacco user, thyroid disorder, tonsillectomy, drug hypersensitivity with sulfa antibiotics, constipation, dyspepsia, insomnia, sinusitis, peripheral swelling, arthralgia, pain in extremity, back pain, surgery, arthroscopic knee surgery , arthroscopy and a reaction to synvisc on her last attempt to use this.The patient's past medical treatment included steroid injection in left knee.On (b)(6) 2014 mri reports revealed degenerative disc disease of most of her lumbar spine with some central canal stenosis and left foraminal stenosis at l4-l5; degenerative arthritis of her left knee.On (b)(6) 2016, x-ray reports revealed sclerotic cystic area note din the medial tibia and is degenerative in nature.The patient's family history included arthritis to father and brother, heart attack to father, heart disorder to father, high blood pressure in father, mother and sister, dementia in mother and sister, stroke in mother, diabetes mellitus in brother, gout in brother, cancer and thyroid problem in sister.The patient's past vaccination(s) was not provided.Concomitant medications included meloxicam (mobic); estradiol, norethisterone acetate (activella); diclofenac potassium (cataflam) ; levothyroxine ,trazodone, depo-medrol, cyclobenzaprine.On (b)(6) 2017, the patient was administered synvisc one (hylan g-f 20, sodium hyaluronate)injection 6 ml 1x intra-articular (with an unknown batch number) for degenerative arthritis and pain of left knee.The pain was primarily medial and was more in the full extension of the knee.She has 0 to 130 degree of motion.Treatment options were discussed.After the sterile prep the left knee was injected with 6 cc of synvisc one.Patient tolerated this well.On (b)(6) 2017, patient reported of increased pain in knee as well as above and below, increased swelling , ambulating with walker.Patient denied fever.On (b)(6) 2017, patient confirmed swelling and pain had improved, patient was informed that synvisc batch was contaminated.On (b)(6) 2018, patient had returned for steroid injection in her left knee.She stated that her knee was not bothering her but since she was leaving for her trip on saturday and would be doing a lot of walking.After sterile prep the left knee was injected with 40 mg of depo-medrol and 2 cc of 1%lidocaine.Patient tolerated this well, she would continue non impact exercising.Patient had been doing some swimming and was recommended to continue.On an unknown date in 2018, it was reported that patient could walk up the stairs, burning had improved and reaction resolved and 1 month relief from synvisc.She reported that she had numbness in right leg and pain in left leg and that mobic had helped her.Outcome : recovering / resolving for pain in knee as well as above and below, swelling, as unknown for ambulating with walker; unknown for numbness in right leg and pain in left leg.Seriousness criteria: disability for ambulatory with walker.
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Event Description
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Ambulating with walker [walking aid user] numbness in right leg [numbness in leg] pain in left leg [pain in leg] pain in knee as well as above and below [knee pain] ([condition worsened]) swelling [knee swelling] ([condition worsened]) case narrative: this case is cross refrenced with case (b)(4).(same patient) initial information received on 13-sep-2018 regarding an unsolicited valid serious case from united states received from a healthcare professional.This case involves a 61 years old female patient who was ambulating with walker, had numbness in right leg, pain in left leg, experienced pain in knee as well as above and below, increased swelling, with the use of hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included tobacco user, thyroid disorder, tonsillectomy, drug hypersensitivity with sulfa antibiotics, constipation, dyspepsia, insomnia, sinusitis, peripheral swelling, arthralgia, pain in extremity, back pain, surgery, arthroscopic knee surgery , arthroscopy and a reaction to synvisc on her last attempt to use this.The patient's past medical treatment included steroid injection in left knee.On (b)(6) 2014 mri reports revealed degenerative disc disease of most of her lumbar spine with some central canal stenosis and left foraminal stenosis at l4-l5; degenerative arthritis of her left knee.On (b)(6) 2016, x ray reports revealed sclerotic cystic area note din the medial tibia and is degenerative in nature.The patient's family history included arthritis to father and brother, heart attack to father, heart disorder to father, high blood pressure in father, mother and sister, dementia in mother and sister, stroke in mother, diabetes mellitus in brother, gout in brother, cancer and thyroid problem in sister.The patient's past vaccination(s) was not provided.Concomitant medications included meloxicam (mobic); estradiol, norethisterone acetate (activella); diclofenac potassium (cataflam) ; levothyroxine ,trazodone, depo-medrol, cyclobenzaprine on (b)(6) 2017, the patient was administered synvisc one (hylan g-f 20, sodium hyaluronate)injection 6 ml 1x intra-articular (with an unknown batch number) for degenrative arthritis and pain of left knee.The pain was primarily medial and was more in the full extension of the knee.She has 0 to 130 degree of motion.Treatment options were discussed.After the sterile prep the left knee was injected with 6 cc of synvisc one.Patient tolerated this well.On (b)(6) 2017, patient reported of increased pain in knee as well as above and below, increased swelling , ambulating with walker.Patient denied fever.On (b)(6) 2017, patient confirmed swelling and pain had improved, patient was informed that synvisc batch was contaminated.On (b)(6) 2018, patient had returned for steroid injection in her left knee.She stated that her knee was not bothering her but since she was leaving for her trip on saturday and would be doing a lot of walking.After sterile prep the left knee was injected with 40 mg of depo-medrol and 2 cc of 1%lidocaine.Patient tolerated this well, she would continue non impact excercising.Patient had been doing some swimming and was recommended to continue.On an unknown date in 2018, it was reported that patient could walk up the stairs, burning had improved and reaction resolved and 1 month relief from synvisc.She reported that she had numbness in right leg and pain in left leg and that mobic had helped her.Outcome: recovering / resolving for pain in knee as well as above and below, swelling, as unknown for ambulating with walker; unknown for numbness in right leg and pain in left leg.Seriousness criteria: disability for ambulatory with walker a product technical complaint was initiated on (b)(6) 2018 for synvisc-one.Batch number: unknown global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa is required.It was the requirement to review all finished batch records for specification conformation 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 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.Follow up was received on 27-sep-2018.No new information was received.Additional information received on 04-oct-2018.Investigation summary received and ptc results added.Clinical curse updated.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction] ambulating with walker [walking aid user] pain in knee as well as above and below/lateral and medial pain [knee pain] ([condition worsened]) numbness in right leg [numbness in leg] pain in left leg [pain in leg] felt dizzy [dizzy] foggy [foggy feeling in head] vertigo [vertigo] ([headache], [ear pain], [nauseated], [diplopia]) elevated blood pressure reading [blood pressure increased] swelling [knee swelling] ([condition worsened]).Case narrative: this case is cross referenced with case (b)(4).Initial information received on 13-sep-2018 regarding an legal unsolicited valid serious case from united states received from a healthcare professional.This case involves a 61 years old female patient who had treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and was ambulating with walker, pain in knee as well as above and below/lateral and medial pain, increased swelling (latency: 1 day), had numbness in right leg, pain in left leg (latency: unknown), felt dizzy, nauseated and foggy, vertigo, elevated blood pressure reading (latency: (b)(6) 2018).A device malfunction was noted in the reported batch number.The patient's past medical history included tonsillectomy, constipation, heartburn, insomnia, sinus infection, swelling in legs, leg pain, thumb surgery, arthroscopic knee surgery, dilatation and curettage and a reaction to synvisc on her last attempt to use this.The patient's past medical treatment included steroid injection in left knee.On (b)(6) 2014 mri reports revealed degenerative disc disease of most of her lumbar spine with some central canal stenosis and left foraminal stenosis at l4-l5; degenerative arthritis of her left knee.On(b)(6) 2016, x ray reports revealed sclerotic cystic area noted in the medial tibia and is degenerative in nature.Patient was former smoker.The patient's family history included arthritis to father and brother, heart attack to father, heart disorder to father, high blood pressure in father, mother and sister, dementia in mother and sister, stroke in mother, diabetes mellitus in brother, gout in brother, cancer and thyroid problem in sister.The patient's past vaccination(s) was not provided.At the time of report, patient had ongoing thyroid problems, sulfa antibiotics allergy, left knee pain, back pain/chronic midline low back pain without sciatica.Concomitant medications included meloxicam (mobic); estradiol, norethisterone acetate (activella); diclofenac potassium (cataflam) ; levothyroxine ,trazodone hydrochloride (desyrel), depo-medrol, cyclobenzaprine hydrochloridex (flexeril) on (b)(6) 2017, the patient was administered synvisc one (hylan g-f 20, sodium hyaluronate) injection 6 ml 1x intra-articular (batch number: 7rsl021; expiration date: may-2020) for degenerative arthritis and pain of left knee.The pain was primarily medial and was more in the full extension of the knee.She has 0 to 130 degree of motion.Treatment options were discussed.After the sterile prep the left knee was injected with 6 cc of synvisc one.Patient tolerated this well.On (b)(6) 2017, patient reported of increased pain in knee as well as above and below, increased swelling, ambulating with walker.Patient denied fever.On (b)(6) 2017, patient confirmed swelling and pain had improved, patient was informed that synvisc batch was contaminated.On (b)(6) 2018, patient had returned for steroid injection in her left knee.She stated that her knee was not bothering her but since she was leaving for her trip on saturday and would be doing a lot of walking.After sterile prep the left knee was injected with 40 mg of depo-medrol and 2 cc of 1%lidocaine.Patient tolerated this well, she would continue non impact excercising.Patient had been doing some swimming and was recommended to continue.On an unknown date in 2018, it was reported that patient could walk up the stairs, burning had improved and reaction resolved and 1 month relief from synvisc.She reported that she had numbness in right leg and pain in left leg and that mobic had helped her.On (b)(6) 2018, patient returned for steroid injection and was injected with methylprednisolone acetate (depo-medrol) in the left knee.She stated her knee was not bothering her a lot right now but would be doing a lot of walking while she was gone and the pain was lateral and medial.On (b)(6) 2018, patient felt dizzy, nauseated and foggy and had recent changes in medications.On the same day, in the afternoon patient had moderate vertigo associated with symptoms of diplopia (patient stated she had episodes of eyes trying to focus but cannot), ear or mastoid pain, headache(s) and nausea; denied abnormal gait, chest pain, confusion or fever(s) (latency: 11 months 4 days).Patient also had elevated blood pressure reading of 140/100 (latency: 11 months 4 days) and was advised that pain may play a part and to take hydrochlorothiazide is blood pressure was above 150/100.Outcome: recovering / resolving for pain in knee as well as above and below/lateral and medial pain, swelling, as unknown for rest of the events except device malfunction.Seriousness criteria: disability for ambulatory with walker and intervention required for pain in knee as well as above and below/lateral and medial pain, disability and intervention required for device malfucntion.A product technical complaint was initiated for synvisc-one.Batch number: 7rsl021 global ptc 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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Follow up was received on 27-sep-2018.No new information was received.Additional information received on 04-oct-2018.Investigation summary received and ptc results added.Clinical curse updated.Text amended accordingly.Additional information was received on 23-jan-2019 from lawyer and case was classified as legal case.Medical history was added.Batch number for hylan g-f 20, sodium hyaluronate was added.Event of device malfunction, vertigo, elevated blood pressure reading and felt dizzy, nauseated and foggy were added with details.Corrective treatment and verbatim for event of pain in knee as well as above and below was updated.Seriousness criteria was updated.Clinical course updated.Text amended accordingly.
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