| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Fever (1858); Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Pain (1994); Synovitis (2094); Chills (2191); Dizziness (2194); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
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| Event Date 11/28/2017 |
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Event Type
Injury
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Event Description
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This unsolicited case from united states was received on (b)(6) 2018 from the patient.This case concerns a (b)(6) female patient who received synvisc one and after few hours had fever, chills, could barely walk, swelling, warm to touch and fluid retention; after an unknown latency could virtually put no weight on it, pain was an 8 after the injection/ pain was from walking up and down stairs.There was device malfunction and experienced injection does not work for me (device ineffective).Medical history included pain: prior to the injection, her pain was a one and half.Past drug, concomitant medication and concurrent condition was provided.On an unknown date in (b)(6) 2017 (a day or two before (b)(6) 2017), patient received treatment with intraarticular synvisc one injection at a dose of 6 ml once (indication: not reported) (batch/ lot number: 7rsl021; expiration date: 31-may-2020) in the right knee at an orthopedic clinic.This was her first synvisc one injection.The patient was directed not to engage in activities such as jogging or tennis soon after the injection.On an unknown date in (b)(6) 2017, few hours after the injection, patient had fever, chills, and could barely walk.It was reported that patient was fine walking before the injection.After the injection, she could put virtually no weight on it.The patient did not use any support before but after the injection, she had crutches.Patient's pain was an 8 after the injection.It was more about the side effects related to the injection.Once it wore off, patient was fine.Prior to the injection, her pain was a one and half.It was from walking up and down stairs.The patient had to go back to the clinic for a cortisone injection to counteract it.Also, she had to have the fluid drawn off her knee from the injection.Fluid was drained but no testing was done.There was a substantial amount of fluid.It seemed clear.The doctor knew what was going on.It was one of the worst fluid retention that the physician assistant (pa) had seen with the injection.After drainage, cortisone injection, the doctor also gave her medication after called naproxen (vimovo).The patient had swelling and it was also warm to the touch.It was so swollen that she could not put pants on.No blood work was done.The cortisone injections only last a short time frame.The patient was healthy and did not take medications regularly.She was a runner and they said she had loose cartilage and there was an alignment issue with her knee cap.This shot was the worst she had ever had.She had never taken a medication that was this traumatic.She was stuck in the knee so many times and was not eager to do any product relative to this ever again.It was reported that this did not work for the patient (device ineffective) and there was device malfunction.The fever lasted for about 24 hours or less.The patient missed a day of work next day because of the fever and chills and she was unable to walk.No further information was provided.Within two to three days, patient was substantially better and recovered from the event.Action taken: unknown corrective treatment: cortisone injection for fever, chills, warm to touch and swelling; cortisone injection; crutches for could barely walk; crutches for could virtually put no weight on it; crutches and naproxen for pain was an 8 after the injection/ pain was from walking up and down stairs; fluid drawn from injection and cortisone for fluid retention outcome: recovered/ resolved for all events (except injection does not work for me) 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for fever, chills, pain was an 8 after the injection/ pain was from walking up and down stairs, device malfunction, swelling, warm to touch, fluid retention; disability and required intervention for could barely walk; disability for could virtually put no weight on it pharmacovigilance comment: sanofi company comment dated 20-mar-2018: this case concerns a patient who received treatment with synvisc one from recall lot and experienced fever, chills, inability to walk, weight bearing difficulty and pain.A significant temporal relationship can be established since events occurred few hours after the injection.Furthermore, the concerned lot number has been identified to have malfunction by the company, and hence, the causal role of suspect cannot be denied in occurrence of the events.
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Event Description
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Fever [fever]; chills [chills]; could barely walk [unable to walk]; could virtually put no weight on it [weight bearing difficulty]; device malfunction [device malfunction]; severe inflammation [inflammation] ([joint pain], [swelling of r knee], [joint warmth], [effusion (r) knee]); injection does not work for me [device ineffective].Case narrative: based on information received on 02-oct-2018, the case has become medically confirmed.This unsolicited case from united states was received on 14-mar-2018 from the patient.This case concerns a 30 year old female patient who received synvisc one and after few hours had fever, chills, could barely walk, swelling/right knee was extremely swollen, warm to touch/hot to touch and fluid retention; after an unknown latency could virtually put no weight on it, pain was an 8 after the injection/ pain was from walking up and down stairs and severe inflammation (after few hours).There was device malfunction and experienced injection does not work for me (device ineffective).Medical history included pain: prior to the injection, her pain was a one and half, light fluid retention, patellofemoral instability, vertigo, high cholesterol, left wrist injury, environmental allergies, tendon release and patellofemoral instability.Patient was a non-smoker but consumed 4 drinks monthly.Patient's surgical history included tendon release, meniscus surgery and knee arthroscopy.Patient had a family history of pancreatic cancer and stroke.The patient was allergic to penicillin (allergic reaction: rash).Concomitant medications included hydrochlorothiazide for fluid retention, centrum vitamins, atorvastatin for cholesterol, azelastine nasal spray and coq-10.On (b)(6) 2017, patient the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (indication: not reported) (batch/ lot number: 7rsl021; expiration date: 31-may-2020) in the right knee for primary osteoarthritis at an orthopedic clinic.This was her first synvisc one injection.Patient's right knee was prepped using aseptic technique.Right knee lateral suprapatellar pouch injection was performed with 3 ml of lidocaine 1% plain for anesthetic.A 21 gauge needle was used.Placement was confirmed by manual palpation.Synvisc one 48 mg (6ml) was injected.Adhesive sterile dressing was used.Patient tolerated the treatment well.The patient was directed not to engage in activities such as jogging or tennis soon after the injection.On an unknown date in (b)(6) 2017, few hours after the injection, patient had fever, chills, as well as severe inflammation, could barely walk/inability to walk for several days.The patient's right knee was extremely swollen and hot to touch.It was reported that patient was fine walking before the injection.After the injection, she could put virtually no weight on it.The patient did not use any support before but after the injection, she had crutches.Patient's pain was an 8 after the injection.It was more about the side effects related to the injection.Once it wore off, patient was fine.Prior to the injection, her pain was a one and half.It was from walking up and down stairs.The patient had to go back to the clinic for a cortisone injection to counteract it.Also, she had to have the fluid drawn off her knee from the injection.Fluid was drained but no testing was done.There was a substantial amount of fluid.It seemed clear.The doctor knew what was going on.It was one of the worst fluid retention that the physician assistant (pa) had seen with the injection.After drainage, cortisone injection, the doctor also gave her medication after called naproxen (vimovo).The patient had swelling and it was also warm to the touch.It was so swollen that she could not put pants on.No blood work was done.The cortisone injections only last a short time frame.The patient was healthy and did not take medications regularly.She was a runner and they said she had loose cartilage and there was an alignment issue with her knee cap.This shot was the worst she had ever had.She had never taken a medication that was this traumatic.She was stuck in the knee so many times and was not eager to do any product relative to this ever again.It was reported that this did not work for the patient (device ineffective) and there was device malfunction.The fever lasted for about 24 hours or less.The patient missed a day of work next day because of the fever and chills and she was unable to walk.No further information was provided.Within two to three days, patient was substantially better and recovered from the event.Action taken: unknown.Corrective treatment: not reported for severe inflammation; cortisone injection for fever, chills, warm to touch/hot to touch and swelling/right knee was extremely swollen; cortisone injection; crutches for could barely walk; crutches for could virtually put no weight on it; crutches and naproxen for pain was an 8 after the injection/ pain was from walking up and down stairs; fluid drawn from injection and cortisone for fluid retention outcome: recovered/resolved for all events on an unknown date in 2017 (except injection does not work for me).A product technical complaint (ptc) was initiated on 14-mar-2018 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 would be completed, corrective and preventive actions would be implemented.Final investigation complete date was 14-mar-2018.Seriousness criteria: required intervention for fever, chills, pain was an 8 after the injection/ pain was from walking up and down stairs, device malfunction, swelling, warm to touch, fluid retention; disability and required intervention for could barely walk; disability for could virtually put no weight on it follow-up information was received on 26-mar-2018.Gptc number was added in narrative.Additional information was received on 28-mar-2018 from the patient.Medical history was updated.Concomitant medications were added.Additional event of severe inflammation was added along with details.The suspect drug's start date was updated.The event term of swelling was updated to swelling/ right knee was extremely swollen.The event term of warm to touch was updated to warm to touch/ hot to touch.Event onset date was updated for the events of fever, chills, could barely walk, could virtually put no weight on it, swelling/ right knee was extremely swollen, warm to touch/ hot to touch.Clinical course was updated.Text was amended accordingly.Additional information received on 02-oct-2018 from healthcare professional.Medical history was updated.Concomitant medication coq-10 was added.Clinical course was updated, and text amended accordingly.
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Event Description
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Fever [fever] chills [chills] could barely walk [unable to walk] could virtually put no weight on it [weight bearing difficulty] device malfunction [device malfunction] toxic synovitis [toxic synovitis] ([swelling of r knee], [joint pain], [stiff knees], [joint inflammation], [effusion (r) knee], [joint warmth]) painful gait/painful range of motion [pain upon movement] limited range of motion of her right knee [joint range of motion decreased] weight gain [weight gain] dizziness [dizziness] antalgic gait [antalgic gait] allergic to synvisc [allergic reaction] injection doesnot work for me [device ineffective] case narrative: based on information received on 02-oct-2018, the case has become medically confirmed.This unsolicited case from united states was received on 14-mar-2018 from the patient.This case concerns a 30 year old female patient who received synvisc one and after few hours had fever, chills, could barely walk, swelling/right knee was extremely swollen, warm to touch/hot to touch and fluid retention; after an unknown latency could virtually put no weight on it, pain was an 8 after the injection/ pain was from walking up and down stairs and toxic synovitis, weight gain, painful gait/ painful range of motion, antalgic gait, dizziness and allergic to synvisc (latency: unknown).There was device malfunction and experienced injection does not work for me (device ineffective).Medical history included pain: prior to the injection, her pain was a one and half, light fluid retention, patellofemoral instability, vertigo, high cholesterol, left wrist injury, environmental allergies, tendon release, primary osteoarthritis of the right knee, acute pain of right knee and patellofemoral instability.Patient was a non-smoker but consumed 4 drinks monthly.Patient's surgical history included tendon release, meniscus surgery and knee arthroscopy.Patient had a family history of pancreatic cancer and stroke.The patient was allergic to penicillin (allergic reaction: rash).Concomitant medications included hydrochlorothiazide for fluid retention, centrum vitamins, atorvastatin for cholesterol, azelastine nasal spray and coq-10.On 28-nov-2017, patient the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (indication: not reported) (batch/ lot number: 7rsl021; expiration date: 31-may-2020) in the right knee for primary osteoarthritis at an orthopedic clinic.This was her first synvisc one injection.Patient's right knee was prepped using aseptic technique.Right knee lateral suprapatellar pouch injection was performed with 3 ml of lidocaine 1% plain for anesthetic.A 21 gauge needle was used.Placement was confirmed by manual palpation.Synvisc one 48 mg (6ml) was injected.Adhesive sterile dressing was used.Patient tolerated the treatment well.The patient was directed not to engage in activities such as jogging or tennis soon after the injection.On an unknown date in nov-2017, few hours after the injection, patient had fever, chills, as well as severe inflammation, could barely walk/inability to walk for several days.The patient's right knee was extremely swollen and hot to touch.It was reported that patient was fine walking before the injection.After the injection, she could put virtually no weight on it.The patient did not use any support before but after the injection, she had crutches.Patient's pain was an 8 after the injection.It was more about the side effects related to the injection.Once it wore off, patient was fine.Prior to the injection, her pain was a one and half.It was from walking up and down stairs.Ever since after receiving synvisc one she had a lot of swelling and pain.She states she has also had a fever and the chills and sometimes is warm to the touch.She has been swollen and it has been stiff which has affected her walking.The patient had to go back to the clinic for a cortisone injection to counteract it.Also, she had to have the fluid drawn off her knee from the injection.On 01-dec-2017, the patient came for visit with a significant effusion in her right knee with a painful gait and painful range of motion.Patient was still struggling quite a bit.Her knee pain was worse as it had ever been.Seeking treatment option.Currently the patient states that the symptoms are moderate.Patient rated her current pain as 5/10.The symptoms were aggravated by daily activities.Doctor thought this was a toxic synovitis-type reaction to the synvisc.After using sterile technique and discussing risks and benefits, 55 cc of serous fluid from her right knee was aspirated.It was tinged with some blood.The doctor knew what was going on.It was one of the worst fluid retention that the physician assistant (pa) had seen with the injection.After drainage and cortisone injection, the patient had received an injection of 40 mg kenalog and 4 cc of marcaine into her right knee.She tolerated the procedure well without any complications.Patient had been provided with some samples of (naproxen) vimovo and also pennsaid and encouraged her to use rest, ice, compression and elevation to help relieve the pain.The patient had swelling and it was also warm to the touch.It was so swollen that she could not put pants on.No blood work was done.The cortisone injections only last a short time frame.The patient was healthy and did not take medications regularly.She was a runner and they said she had loose cartilage and there was an alignment issue with her knee cap.This shot was the worst she had ever had.She had never taken a medication that was this traumatic.She was stuck in the knee so many times and was not eager to do any product relative to this ever again.It was reported that this did not work for the patient (device ineffective) and there was device malfunction.The fever lasted for about 24 hours or less.The patient missed a day of work next day because of the fever and chills and recovered from the event.No further information was provided.Within two to three days, patient was substantially better.On 10-jan-2018, the patient again came for visit for treatment options.She was really complaining mainly of her knees.She was struggling with both knees, right hurts worse than the left.The symptoms were aggravated by ascending stairs and descending stairs.Patient stated that the cortisone injection was providing her with short term relief, however she wanted long term options.She was unable to walk.The patient had antalgic gait and full weight bearing, but mild swelling persisted.Physical exam showed she had 0 to 120 degrees range of motion with difficulty squatting.Difficulty ascending and descending stairs.Patient still had trace effusion to the right knee and no effusion to the left knee.On 7-aug-2018, mri of her right knee was done that showed chondromalacia of the patella of the right knee i.E.Osteoarthritis in the patellofemoral joint.She was doing well after arthroscopy in 2001 and 2002.Now, she was struggling with her right knee.Doctor tried to get approved for synvisc, but she had a toxic reaction.She would like her to try to get use to another type of viscosupplementation.Doctor would try to use euflexxa to see if she could avoid the toxic synovitis and see that would help with her symptoms of the right knee.Corrective treatment: cortisone injection for fever, chills; arthrocentesis and cortisone injection with triamcinolone acetonide (kenalog) and bupivacaine hydrochloride (marcaine) for toxic synovitis; cortisone injection and crutches for could barely walk; crutches for could virtually put no weight on it; not reported for all other events outcome: not recovered/ resolved for toxic synovitis, painful gait/ painful range of motion and antalgic gait; unknown for weight gain and allergic to synvisc and dizziness, recovered/resolved for all other events a product technical complaint (ptc) was initiated on 14-mar-2018 for "synvisc one".Batch number 7rsl021, global ptc number: 53151 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 would be completed, corrective and preventive actions would be implemented.Final investigation complete date was 14-mar-2018.Seriousness criteria: required intervention for fever, chills, pain was an 8 after the injection/ pain was from walking up and down stairs, device malfunction, swelling, warm to touch, fluid retention; disability and required intervention for could barely walk; disability for could virtually put no weight on it follow-up information was received on 26-mar-2018.Gptc number was added in narrative.Additional information was received on 28-mar-2018 from the patient.Medical history was updated.Concomitant medications were added.Additional event of severe inflammation was added along with details.The suspect drug's start date was updated.The event term of swelling was updated to swelling/ right knee was extremely swollen.The event term of warm to touch was updated to warm to touch/ hot to touch.Event onset date was updated for the events of fever, chills, could barely walk, could virtually put no weight on it, swelling/ right knee was extremely swollen, warm to touch/ hot to touch.Clinical course was updated.Text was amended accordingly.Additional information received on 02-oct-2018 from healthcare professional.Medical history was updated.Concomitant medication coq-10 was added.Clinical course was updated, and text amended accordingly.Additional information received on 28-nov-2018 from lawyer.Events of weight gain, toxic synovitis, painful gait/ painful range of motion, antalgic gait, dizziness and allergic to synvisc was added.Medical history was added.Corrective treatment details was added.Clinical course was updated and text amended accordingly.
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Event Description
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This unsolicited case from united states was received on 14-mar-2018 from the patient.This case concerns a 30 year old female patient who received synvisc one and after few hours had fever, chills, could barely walk, swelling/right knee was extremely swollen, warm to touch/hot to touch and fluid retention; after an unknown latency could virtually put no weight on it, pain was an 8 after the injection/ pain was from walking up and down stairs and severe inflammation (after few hours).There was device malfunction and experienced injection doesnot work for me (device ineffective).Medical history included pain: prior to the injection, her pain was a one and half, light fluid retention, vertigo.The patient was allergic to penicillin (allergic reaction: rash).Concomitant medications included hydrochlorothiazide for fluid retention, centrum vitamins, atorvastatin for cholesterol and azelastine nasal spray.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (indication: not reported) (batch/ lot number: 7rsl021; expiration date: 31-may-2020) in the right knee at an orthopedic clinic.This was her first synvisc one injection.The patient was directed not to engage in activities such as jogging or tennis soon after the injection.On an unknown date in (b)(6) 2017, few hours after the injection, patient had fever, chills, as well as severe inflammation, could barely walk/inability to walk for several days.The patient's right knee was extremely swollen and hot to touch.It was reported that patient was fine walking before the injection.After the injection, she could put virtually no weight on it.The patient did not use any support before but after the injection, she had crutches.Patient's pain was an 8 after the injection.It was more about the side effects related to the injection.Once it wore off, patient was fine.Prior to the injection, her pain was a one and half.It was from walking up and down stairs.The patient had to go back to the clinic for a cortisone injection to counteract it.Also, she had to have the fluid drawn off her knee from the injection.Fluid was drained but no testing was done.There was a substantial amount of fluid.It seemed clear.The doctor knew what was going on.It was one of the worst fluid retention that the physician assistant (pa) had seen with the injection.After drainage, cortisone injection, the doctor also gave her medication after called naproxen (vimovo).The patient had swelling and it was also warm to the touch.It was so swollen that she could not put pants on.No blood work was done.The cortisone injections only last a short time frame.The patient was healthy and did not take medications regularly.She was a runner and they said she had loose cartilage and there was an alignment issue with her knee cap.This shot was the worst she had ever had.She had never taken a medication that was this traumatic.She was stuck in the knee so many times and was not eager to do any product relative to this ever again.It was reported that this did not work for the patient (device ineffective) and there was device malfunction.The fever lasted for about 24 hours or less.The patient missed a day of work next day because of the fever and chills and she was unable to walk.No further information was provided.Within two to three days, patient was substantially better and recovered from the event.Action taken: unknown corrective treatment: not reported for severe inflammation; cortisone injection for fever, chills, warm to touch/hot to touch and swelling/right knee was extremely swollen; cortisone injection; crutches for could barely walk; crutches for could virtually put no weight on it; crutches and naproxen for pain was an 8 after the injection/ pain was from walking up and down stairs; fluid drawn from injection and cortisone for fluid retention outcome: recovered/resolved for all events (except injection doesnot work for me) a pharmaceutical technical complaint was initiated with gptc number: 53151 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for fever, chills, pain was an 8 after the injection/ pain was from walking up and down stairs, device malfunction, swelling, warm to touch, fluid retention; disability and required intervention for could barely walk; disability for could virtually put no weight on it follow-up information was received on 26-mar-2018.Gptc number was added in narrative.Additional information was received on 28-mar-2018 from the patient.Medical history was upadetd.Concomitant medications were added.Additional event of severe inflammation was added along with details.The suspect drug's start date was updated.The event term of swelling was updated to swelling/ right knee was extremely swollen.The event term of warm to touch was updated to warm to touch/ hot to touch.Event onset date was updated for the events of fever, chills, could barely walk, could virtually put no weight on it, swelling/ right knee was extremely swollen, warm to touch/ hot to touch.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi comapny commentfollow up dated (b)(6) 2018: new information recieved doesnot change prior comprehensive assessment of the case.This case concerns a patient who received treatment with synvisc one from recall lot and experienced fever, chills, inability to walk, weight bearing difficulty and pain.A significant temporal relationship can be established since events occurred few hours after the injection.Furthermore, the concerned lot number has been identified to have malfunction by the company, and hence, the causal role of suspect cannot be denied in occurrence of the events.
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