MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 11/17/2017

Event Type malfunction

Event Description

This spontaneous case from united states was received on (b)(6) 2018 from the patient this case concerns a (b)(6) male patient who initiated treatment with synvisc one and after few hours had knee swelled bad/it was so big, had pain that was bad/ incredible amount of pain, knee started feeling stiff, couldn't get out of the bed.On the next day, doctor took out 4 large syringes of fluid.Patient was limping and couldn't put one ounce of weight on knee after an unknown latency of receiving synvisc one.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once (indication: not provided; batch/ lot number and expiry date: unknown) in right knee.On the same day after a few hours, patient's knee was hurting, he couldn't get out of bed, his knee swelled badly and started feeling stiff.On (b)(6) 2018, the next day, patient went to the er where the doctor took out 4 large syringes of fluid.They did a white blood cell count change and cultured the fluid.Patient was given a high level steroid orally.The patient took tylenol as well.The patient had to use a wheelchair the day after getting the shot and then moved to where he was using crutches (onset: (b)(6) 2017; latency: unknown).He had an incredible amount of pain.Then he was limping for a while.The patient couldn't put one ounce of weight on my knee (onset: (b)(6) 2017; latency: unknown).Corrective treatment: oral steroid for knee swelled bad/it was so big, knee started feeling stiff; oral steroid, tylenol for the pain was bad/ incredible amount of pain; oral steroid, took out 4 large syringes of fluid for took out 4 large syringes of fluid; not reported for rest of the events outcome: recovering for the pain was bad/ incredible amount of pain; not recovered for rest of the events seriousness criteria: required intervention for knee swelled bad/it was so big, knee started feeling stiff, the pain was bad/ incredible amount of pain and took out 4 large syringes of fluid a product technical complaint was initiated and the results of the same were pending.

Event Description

This spontaneous case from united states was received on 11-jan-2018 from the patient this case concerns a (b)(6) male patient who initiated treatment with synvisc one and after few hours had knee swelled bad/it was so big/severe knee swelling, knee redness, the pain was bad/ incredible amount of pain/insufferable pain, knee started feeling stiff, couldn't get out of the bed.On the next day, doctor took out 4 large syringes of fluid.Patient was limping and couldn't put one ounce of weight on knee after an unknown latency of receiving synvisc one.No medical history, previous medications, concomitant medications and concurrent conditions were reported.Concomitant medications: lisinopril, hydrocodone.Medical history included: right knee surgery, wrist bone tumor (benign distal radial bone) and high blood pressure.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for osteoarthritis and knee pain (batch/ lot number and expiry date: unknown) in right knee.On the same day after a few hours, patient's knee was hurting, it was red he couldn't get out of bed, his knee swelled badly and started feeling stiff.On (b)(6) 2018, the next day, patient went to the er where the doctor took out 4 large syringes of fluid.They did a white blood cell count change and cultured the fluid.Patient was given a high level steroid orally.The patient took tylenol as well.The patient had to use a wheelchair the day after getting the shot and then moved to where he was using crutches (onset: (b)(6) 2017; latency: unknown).He had an incredible amount of pain.Then he was limping for a while.The patient couldn't put one ounce of weight on my knee (onset: (b)(6) 2017; latency: unknown).Corrective treatment: er, wheelchair, crutches, cane user for couldn't get out of the bed; wheelchair, crutches, cane user for limping; oral steroid, antibiotics for knee swelled bad/it was so big/severe knee swelling; oral steroid, tylenol, antibiotics for the pain was bad/ incredible amount of pain/insufferable pain; oral steroid for knee started feeling stiff; oral steroid, took out 4 large syringes of fluid, antibiotics for took out 4 large syringes of fluid; wheel chair, crutches, antibiotics for knee redness; not reported for couldn't put one ounce of weight on knee a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51927 the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Outcome: recovered for knee swelled bad/it was so big/severe knee swelling, the pain was bad/ incredible amount of pain/insufferable pain and knee redness; not recovered for others seriousness criteria: disability for couldn't get out of the bed, limping; required intervention for knee swelled bad/it was so big/severe knee swelling, the pain was bad/ incredible amount of pain/insufferable pain, knee started feeling stiff and took out 4 large syringes of fluid additional information was received on 29-jan-2018 from the patient.Event of knee redness was added.Event of knee swelled bad/it was so big was updated to knee swelled bad/it was so big/severe knee swelling; the pain was bad/ incredible amount of pain was updated to the pain was bad/ incredible amount of pain/insufferable pain.Concomitant medications and medical history was added.Clinical course was updated and text amended accordingly additional information was received on 02-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 02-feb-2018: the follow-up information received does not alter the overall case assessment.This case concerns a patient who after receiving synvisc one injection experienced mobility decreased, limping disability and underwent intervention due to right knee swelling, pain, stiffness and knee effusion.He also experienced injection site erythema and weight bearing difficulties.The temporal relationship can be established between the events and the suspect product based on the available information.Therefore, pharmacological plausibility of the events to the product cannot be excluded.Moreover, lack of information regarding the lot number, patient's relevant medical history and concurrent conditions makes the complete case assessment difficult.

Event Description

This spontaneous case from united states was received on 11-jan-2018 from the patient.This case concerns a (b)(6) male patient who initiated treatment with synvisc one and after few hours had knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen, knee redness/ red, the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe 10 on scale of 1-10, knee started feeling stiff, couldn't get out of the bed/ unable to get out of bed, on the same day experienced leg swelling, warm to touch.On the next day, doctor took out 4 large syringes of fluid and patient had white blood count elevated (01 day later).Patient was limping and couldn't put one ounce of weight on knee/ unable to bear weight due to pain after an unknown latency of receiving synvisc one and 61 days later experienced influenza.No previous medications reported.Concomitant medications: lisinopril, hydrocodone, hydrochlorothiazide, cyclobenzaprine, prednisone, amoxicillin, alprazolam (xanax), fluoxetine hydrochloride.Medical history included: right knee surgery, wrist bone tumor (benign distal radial bone) and high blood pressure, allergic rhinitis, acute pharyngitis, pain in wrist, ganglion of joint, sprain of wrist, otitis externa, fatigue, cellutitis and abscess of unspecified site, anxiety, essential (primary) hypertension, left low back pain, unspecified chronicity, with sciatica presence unspecified, acute pharyngitis.The patient was a nonsmoker.The patient had no known drug allergies.The patient had depression (the onset of the depression had been variable and had been occurring in a persistent pattern for months.The course had been increasing.The depression was described as feeling blue, sad, nervous and tired.The symptoms had been associated with marital problems).The patient's medical history also included wrist mass (the wrist mass was characterized as a localized.The wrist mass was described as being located in the dorsal radial.The wrist mass was aggravated by any movement relieving factors include rest) and neck mass (the onset of the mass had been gradual (swollen lump on left side of neck) and had been occurring in a persistent pattern for 1 week.The course had been increasing, the mass was described as moderate.Neck mass notes: swells more at night.Patient started taking his wife's antibiotics and his symptoms were improving).The patient also had anxiety.As of (b)(6) 2009, it was reported that the onset of the anxiety, had been gradual and had been occurring in a persistent pattern for 10 weeks.The course had been increasing.The anxiety was characterized as nervousness.There are no specific phobias.The symptoms had been associated with agitation and insomnia.As of (b)(6) 2014, it was reported that the onset of the anxiety had been sudden and had been occurring in a persistent pattern for 2 days.The course has been increasing.The anxiety was characterized as apprehension, expectant dread, sinking feeling, nervousness, extreme fear and there are no specific phobias.Precipitating factors include: (relationship issue).The symptoms had been associated with feeling of sadness and insomnia.As of (b)(6) 2011, the patient had a complaint of injury.The injury occurred when ((b)(6) 2011 was getting off the wave runner and scrapped his left leg on his trailer.He was in the water at the time.Patient had a large black and green bruise on the left calf.No swelling or drainage.There were 4 scratches noted, areas were scabbed over.No drainage.The injury occurred 3 days ago.The course had been decreasing.The injury was described as mild.The injury was described as being located in the left leg (calf).The patient's medical history also included pain.The onset of the pain had been sudden and had been occurring in a persistent pattern for 2 days.The course had been constant.The pain was characterized as shooting and burning.The pain was described as being located in the lower back.The pain does not radiate.The symptoms were relieved by lying down.The pain had been associated with back stiffness.Pain: patient was playing basketball when injury happened.The patient also had complaint of ear pain.The onset of the pain had been sudden and had been occurring in a persistent pattern for 2 clays.The course had been increasing.The pain was described as a moderate dull aching and pressure, the pain was described as being located in the inner ear.The pain was felt in the left ear.The symptoms had been associated with decreased hearing.Patient's hypertension symptoms included headache and shortness of breath.It was reported that recent blood pressure has been mostly < 190/100s.The patient describes this as moderate in severity and improving, symptoms are exacerbated by weight gain.Associated symptoms include weakness.Note for "hypertension": pt had not been taking his blood pressure medication, all reports from (b)(6) all normal, he has been inking medication since.Blood pressure running 138-191/88-117.The patient had possible kidney infection onset: (b)(6) 2017; quality: aching, sharp, pressure timing: sudden onset severity: severe.At the time of visit on (b)(6) 2017, it was reported that the patient had a history of low back pain and he had some discomfort for a couple of days but a few hours ago he started having a severe sharp pain in his left lower back.He had not done anything out of the ordinary but he did lift weights regularly.The patient had been sleeping poorly and had decreased energy level.The patient had allergy (iodinated contrast).The patient was alcoholic.Patient's family history included colon cancer.Mother; lung cancer.Father; asthma.Brother.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for osteoarthritis and knee pain (batch/ lot number and expiry date: unknown) in right knee.On the same day after a few hours, patient's knee was hurting, it was red he couldn't get out of bed, his knee swelled badly and started feeling stiff.Patient reported that at about 0830 in the night it started swelling and it became very sore.The same day, patient had severe swelling in the right knee, extreme pain and was unable to get out of bed.The same day, the patient experienced knee pain (location: right knee; quality: painful, cramping, shooting timing: constant severity: severe, 10 on scale of 1-10 associated signs & symptoms: leg swelling +, warm to touch, red) the patient stated that he never had that shot before.He further stated that he had some pain medication at home, he says that he took two around 0700am in the morning of (b)(6)2018 and was still in severe pain.He stated that they have been icing it all night.On (b)(6) 2018, the next day, patient went to the er where the doctor took out 4 large syringes of fluid.The patient was in the er for several hours.They did a white blood cell count change and cultured the fluid.The same day, the patient experienced swelling of right knee joint.That day, (latency: 01 day) blood count/panel revealed elevated white blood count.Patient was given a high level steroid orally.The patient took tylenol as well.Patient's review of system on visit showed constitutional: fatigue (-), weight gain (-), weight loss (-); heent: nasal congestion (-); gastroenterology: constipation (-), diarrhea (-), vomiting (-), nausea (-), abdominal pain (-); musculoskeletal: joint pain (+); skin: rash (-), skin lesion (-).The physical exam showed general: appearance: appears well, tired appearing; respiratory: inspection: breathing easily, symmetrical expansion, no deformities, rate/pattern: with a normal respiration rate and pattern; cardiovascular: heart rate: a normal heart rate, cardiac rhythm: there is a regular rhythm; musculoskeletal: general a right knee swollen; stated unable to bear weight due to pain; neurologic: general: alert and oriented x 3, mood and affect appropriate for age, gait: wheelchair; skin: general: no rashes, ecchymosis, petechise, or lesions noted.The patient was prescribed ciprofloxacin on (b)(6) 2018.The patient had to use a wheelchair the day after getting the shot and then moved to where he was using crutches (onset: (b)(6) 2017; latency: unknown).He had an incredible amount of pain.Then he was limping for a while.The patient couldn't put one ounce of weight on my knee (onset: (b)(6) 2017; latency: unknown).On (b)(6) 2018, 61 days after initiating treatment, the patient was diagnosed with influenza.The patient also had sudden respiratory illness symptoms of head congestion, runny nose, cough, sinus pressure (duration: 1 day progression; worsening severity: moderate).It was reported that the patient had no known exposure modifying factors: better with otc medications and associated signs and symptoms included fever, post nasal drainage, cough, malaise, chine, vomiting.Patient's weight upon visit was included bp systolic/diastolic: 130/78 mmhg.Temperature; 97,8 f.Pulse: 72/min, respiration:15/min.Patient's review of system on visit showed constitutional: fatigue (positive), fever (positive), malaise (positive); heent: nasal congestion (positive), sore throat (positive); respiratory: cough (positive), chest congestion (negative), shortness of breath (negative); gastroenterology; abdominal pain (negative); skin: rash (negative), skin lesion (negative).Patient's physical exam showed general: appearance: mildly ill appearing, no acute distress, tired appearing, nourishment: well nourished, hydration: well hydrated; heent: eyes: pupils round and reactive, conjunctiva clear, ear canals: the ear canals are free of abnormal discharges and impactions, tympanic membranes: dull, nasal mucosa: nasal congestion, pharynx: cobblestoning; head & neck: heed adult: normocephalic, atrarnautic, neck: the neck is supple, no lymphacienopathy, thyroid: there is no palpable thyromegaly nor thyroid nodule, carotid bruit(s): without audible carotid bruits; respiratory: inspection: breathing easily, symmetrical expansion, no deformities, rate/pattern: with a normal respiration rate and pattern, breath sounds: there are normal breath sounds present, no rales, rhonchi, or wheezing; cardiovascular: heart rate: a normal heart rate, cardiac rhythm: there is a regular rhythm, murmur: no murmurs, extremities: no edema; neurologic: general: alert and oriented x 3, mood and affect appropriate for age, gait: normal; skin: general: no rashes, ecchymosis, petechlae, or lesions noted.Corrective treatment: er, wheelchair, crutches, cane user for couldn't get out of the bed/ unable to get out of bed; wheelchair, crutches, cane user for limping; oral steroid, antibiotics for k knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen; oral steroid, tylenol, antibiotics for the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe 10 on scale of 1-10; oral steroid for knee started feeling stiff; oral steroid, took out 4 large syringes of fluid, antibiotics for took out 4 large syringes of fluid; wheel chair, crutches, antibiotics for knee redness/ red; not reported for couldn't put one ounce of weight on knee and white blood count elevated, warm to touch, leg swelling; oseltamivir phosphate (tamiflu), otc medications for influenza a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51927 the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required outcome: recovered for and knee redness/ red; unknown for warm to touch, leg swelling, influenza; not recovered for others seriousness criteria: disability for couldn't get out of the bed/ unable to get out of bed, limping; required intervention for knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen, the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe 10 on scale of 1-10, knee started feeling stiff and took out 4 large syringes of fluid additional information was received on 29-jan-2018 from the patient.Event of knee redness was added.Event of knee swelled bad/it was so big was updated to knee swelled bad/it was so big/severe knee swelling; the pain was bad/ incredible amount of pain was updated to the pain was bad/ incredible amount of pain/insufferable pain.Concomitant medications and medical history was added.Clinical course was updated and text amended accordingly additional information was received on 02-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 09-feb-2018 from patient.Additional event of white blood count elevated was added.Event terms were updated: from knee swelled bad/it was so big/severe knee swelling to knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee; from the pain was bad/ incredible amount of pain/insufferable pain to the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain and from couldn't get out of the bed to couldn't get out of the bed/ unable to get out of bed.Clinical course was updated.Text was amended accordingly.Additional information was received on 28-feb-2018 from other non-healthcare professional (outside counsel).Additional event of leg swelling, warm to touch and influenza were added with details.Symptoms of knee pain were added.Patient's medical history, family history, concomitant medication were added.Event term of the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain was updated to the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe 10 on scale of 1-10; knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee was updated to knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen and their outcome was updated to not recovered.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 28-feb-2018: the follow-up information received does not alter the overall case assessment.This case concerns a patient who after receiving synvisc one injection experienced mobility decreased, limping disability and underwent intervention due to right knee swelling, pain, stiffness and knee effusion.He also experienced injection site erythema and weight bearing difficulties.The temporal relationship can be established between the events and the suspect product based on the available information.Therefore, pharmacological plausibility of the events to the product cannot be excluded.Moreover, lack of information regarding the lot number, patient's relevant medical history and concurrent conditions makes the complete case assessment difficult.

Event Description

This spontaneous case from united states was received on 11-jan-2018 from the patient.This case concerns a (b)(6) years old male patient who initiated treatment with synvisc one and after few hours had knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee, knee redness, the pain was bad/ incredible amount of pain/ insufferable pain/ extreme pain, knee started feeling stiff, couldn't get out of the bed/ unable to get out of bed.On the next day, doctor took out 4 large syringes of fluid and patient had white blood count elevated (01 day later).Patient was limping and couldn't put one ounce of weight on knee after an unknown latency of receiving synvisc one.No previous medications reported.Concomitant medications: lisinopril, hydrocodone.Medical history included: right knee surgery, wrist bone tumor (benign distal radial bone) and high blood pressure.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for osteoarthritis and knee pain (batch/ lot number and expiry date: unknown) in right knee.On the same day after a few hours, patient's knee was hurting, it was red he couldn't get out of bed, his knee swelled badly and started feeling stiff.The same day, patient had severe swelling in the right knee, extreme pain and was unable to get out of bed.On (b)(6) 2018, the next day, patient went to the er where the doctor took out 4 large syringes of fluid.The patient was in the er for several hours.They did a white blood cell count change and cultured the fluid.That day, (latency: 01 day) blood count/panel revealed elevated white blood count.Patient was given a high level steroid orally.The patient took tylenol as well.The patient had to use a wheelchair the day after getting the shot and then moved to where he was using crutches (onset: (b)(6) 2017; latency: unknown).He had an incredible amount of pain.Then he was limping for a while.The patient couldn't put one ounce of weight on my knee (onset: (b)(6) 2017; latency: unknown).Corrective treatment: er, wheelchair, crutches, cane user for couldn't get out of the bed/ unable to get out of bed; wheelchair, crutches, cane user for limping; oral steroid, antibiotics for knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee; oral steroid, tylenol, antibiotics for the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain; oral steroid for knee started feeling stiff; oral steroid, took out 4 large syringes of fluid, antibiotics for took out 4 large syringes of fluid; wheel chair, crutches, antibiotics for knee redness; not reported for couldn't put one ounce of weight on knee and white blood count elevated a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Outcome: recovered for knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee, the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain and knee redness; not recovered for others seriousness criteria: disability for couldn't get out of the bed/ unable to get out of bed, limping; required intervention for knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee, the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain, knee started feeling stiff and took out 4 large syringes of fluid additional information was received on 29-jan-2018 from the patient.Event of knee redness was added.Event of knee swelled bad/it was so big was updated to knee swelled bad/it was so big/severe knee swelling; the pain was bad/ incredible amount of pain was updated to the pain was bad/ incredible amount of pain/insufferable pain.Concomitant medications and medical history was added.Clinical course was updated and text amended accordingly additional information was received on 02-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 09-feb-2018 from patient.Additional event of white blood count elevated was added.Event terms were updated: from knee swelled bad/it was so big/severe knee swelling to knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee; from the pain was bad/ incredible amount of pain/insufferable pain to the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain and from couldn't get out of the bed to couldn't get out of the bed/ unable to get out of bed.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 09-feb-2018: the follow-up information received doesnot alter the overall case assessment.This case concerns a patient who after receiving synvisc one injection experienced mobility decreased, limping disability and underwent intervention due to right knee swelling, pain, stiffness and knee effusion.He also experienced injection site erythema and weight bearing difficulties.The temporal relationship can be established between the events and the suspect product based on the available information.Therefore, pharmacological plausibility of the events to the product cannot be excluded.Moreover, lack of information regarding the lot number, patient's relevant medical history and concurrent conditions makes the complete case assessment difficult.

Event Description

This spontaneous case from united states was received on (b)(6) 2018 from the patient this case concerns a 48 years old male patient who initiated treatment with synvisc one and after few hours had knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen, knee redness/ red, the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe10 on scale of 1-10, knee started feeling stiff, couldn't get out of the bed/ unable to get out of bed, on the same day experienced leg swelling, warm to touch.On the next day, doctor took out 4 large syringes of fluid and patient had white blood count elevated (01 day later).Patient was limping and couldn't put one ounce of weight on knee/ unable to bear weight due to pain after an unknown latency of receiving synvisc one and 61 days later experienced influenza.Concomitant medications: lisinopril, hydrocodone, hydrochlorothiazide, cyclobenzaprine, prednisone, amoxicillin, alprazolam (xanax), fluoxetine hydrochloride.Medical history included: right knee surgery, wrist bone tumor (benign distal radial bone) and high blood pressure, allergic rhinitis, acute pharyngitis, pain in wrist, ganglion of joint, sprain of wrist, otitis externa, fatigue, cellulitis and abscess of unspecified site, anxiety, essential (primary) hypertension, left low back pain, unspecified chronicity, with sciatica presence unspecified.The patient was a nonsmoker.The patient had no known drug allergies.The patient had depression (the onset of the depression had been variable and had been occurring in a persistent pattern for months.The course had been increasing.The depression was described as feeling blue, sad, nervous and tired.The symptoms had been associated with marital problems).The patient's medical history also included wrist mass (the wrist mass was characterized as a localized.The wrist mass described as located in the dorsal radial.The wrist mass was aggravated by any movement relieving factors include rest) and neck mass (the onset of the mass had been gradual (swollen lump on left side of neck) and had been occurring in a persistent pattern for 1 week.The course had been increasing, the mass was described as moderate.Neck mass notes: swells more at night.Patient started taking his wife's antibiotics and his symptoms were improving).The patient also had anxiety.As of (b)(6) 2009, it was reported that the onset of the anxiety, had been gradual and had been occurring in a persistent pattern for 10 weeks.The course had been increasing.The anxiety was characterized as nervousness.There are no specific phobias.The symptoms had been associated with agitation and insomnia.As of 24-mar-2014, it was reported that the onset of the anxiety had been sudden and had been occurring in a persistent pattern for 2 days.The course has been increasing.The anxiety was characterized as apprehension, expectant dread, sinking feeling, nervousness, extreme fear and there are no specific phobias.Precipitating factors include: (relationship issue).The symptoms had been associated with feeling of sadness and insomnia.As of 01-jun-2011, the patient had a complaint of injury.The injury occurred when (5-29-11 was getting off the wave runner and scrapped his left leg on his trailer.He was in the water at the time.Patient had a large black and green bruise on the left calf.No swelling or drainage.There were 4 scratches noted, areas were scabbed over.No drainage.The injury occurred 3 days ago.The course had been decreasing.The injury was described as mild.The injury described as being located in the left leg (calf).The patient's medical history also included pain.The onset of the pain had been sudden and had been occurring in a persistent pattern for 2 days.The course had been constant.The pain was characterized as shooting and burning.The pain described as located in the lower back.The pain does not radiate.The symptoms were relieved by lying down.The pain had been associated with back stiffness.Pain: patient was playing basketball when injury happened.The patient also had complaint of ear pain.The onset of the pain had been sudden and had been occurring in a persistent pattern for 2 clays.The course had been increasing.The pain was described as a moderate dull aching and pressure, the pain described as being located in the inner ear.The pain was felt in the left ear.The symptoms had been associated with decreased hearing.Patient's hypertension symptoms included headache and shortness of breath.It was reported that recent blood pressure has been mostly < 190/100s.The patient describes this as moderate in severity and improving, symptoms are exacerbated by weight gain.Associated symptoms include weakness.Note for "hypertension": pt had not been taking his blood pressure medication, all reports from jph all normal, he has been inking medication since.Blood pressure running 138-191/88-117.The patient had possible kidney infection onset: 17-apr-2017; quality: aching, sharp, pressure timing: sudden onset severity: severe.At the time of visit on 19-apr-2017, it was reported that the patient had a history of low back pain and he had some discomfort for a couple of days but a few hours ago he started having a severe sharp pain in his left lower back.He had not done anything out of the ordinary but he did lift weights regularly.The patient had been sleeping poorly and had decreased energy level.The patient had allergy (iodinated contrast).The patient was alcoholic.Patient's family history included colon cancer.Mother; lung cancer.Father; asthma.Brother.On 19-apr-2017, patient presented with right knee pain which got stirred up while playing basket-ball a couple of weeks ago, happened earlier but pain went away after resting but this time, it never let -up, underwent mri scan of right knee: showed irregularity of the medial femoral condyle of the articular surface but no evidence of osteonecrosis and no evidence of medical meniscal tear.Steroid injection was given.Felt better but not 100%.On 31-may-2016, showed no effusion and full range motion in knee.On 26-jul-2016, patient again presented with request of steroid injection.Went on vacation, had minor twisting injury to the knee, had increasing pain.Underwent steroid injection depo medrol with lidocaine and marcaine in right knee.On 06-sep- 2016, persistent pain, while playing golf, he tweaked and had sharp stabbing pain in medial joint.Mri showed degeneration of medial meniscus as well as joint space narrowing and bruising of medical tibial plateau.Had couple of cortisone injection, provide temporary relief.No swelling or effusion today.Arthroscopy recommended.On 19-oct-2016, patient underwent arthroscopic medical meniscectomy for internal derangement of right knee and primary osteoarthritis.Patient developed rash around his right knee.On 03-nov-2016, was in football game, and fell suffering a contusion to the anteromedial aspect of the right knee and had some medial knee pain since.X-ray was normal.Started medication vimovo.Had right elbow pain despite no specific injury, which worse at night increased pain with gripping, had exquisite tenderness to palpation over the lateral epicondyle.Patient had steroid injection (depo medrol with lidocaine and marcaine) on knee and right elbow, wear tennis elbow strap for symptomatic relief with activity.On 18-oct-2017, had knee effusion, was tender at the medical joint, have some mild crepitation with motion.Injected with methylprednisolone acetate (depo- medrol) and some bupivacaine hydrochloride (marcaine).On 17-nov-2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for osteoarthritis and knee pain (batch/ lot number and expiry date: unknown) in right knee.On the same day after a few hours, patient's knee was hurting, it was red he couldn't get out of bed, his knee swelled badly and started feeling stiff.Patient reported that at about 0830 in the night it started swelling and it became very sore.The same day, patient had severe swelling in the right knee, extreme pain and was unable to get out of bed.The same day, the patient experienced knee pain (location: right knee; quality: painful, cramping, shooting timing: constant severity: severe, 10 on scale of 1-10 associated signs & symptoms: leg swelling +, warm to touch, red) the patient stated that he never had that shot before.He further stated that he had some pain medication at home, he says that he took two around 0700am in the morning of 18-nov-2018 and was still in severe pain.He stated that they have been icing it all night.On 18-nov-2018, the next day, patient went to the er where the doctor took out 4 large syringes of fluid.The patient was in the er for several hours.They did a white blood cell count change and cultured the fluid.The same day, the patient experienced swelling of right knee joint.That day, (latency: 01 day) blood count/panel revealed elevated white blood count.Patient was given a high level steroid orally.The patient took tylenol as well.Patient's review of system on visit showed constitutional: fatigue (-), weight gain (-), weight loss (-); heent: nasal congestion (-); gastroenterology: constipation (-), diarrhea (-), vomiting (-), nausea (-), abdominal pain (-); musculoskeletal: joint pain (+); skin: rash (-), skin lesion (-).The physical exam showed general: appearance: appears well, tired appearing; respiratory: inspection: breathing easily, symmetrical expansion, no deformities, rate/pattern: with a normal respiration rate and pattern; cardiovascular: heart rate: a normal heart rate, cardiac rhythm: there is a regular rhythm; musculoskeletal: general a right knee swollen; stated unable to bear weight due to pain; neurologic: general: alert and oriented x 3, mood and affect appropriate for age, gait: wheelchair; skin: general: no rashes, ecchymosis, petechise, or lesions noted.The patient was prescribed ciprofloxacin on 18-nov-2018.The patient had to use a wheelchair the day after getting the shot and then moved to where he was using crutches (onset: nov-2017; latency: unknown).He had an incredible amount of pain.Then he was limping for a while.The patient couldn't put one ounce of weight on my knee (onset: nov- 2017; latency: unknown).On 17-jan-2018, 61 days after initiating treatment, the patient was diagnosed with influenza.The patient also had sudden respiratory illness symptoms of head congestion, runny nose, cough, sinus pressure (duration: 1 day progression; worsening severity: moderate).It was reported that the patient had no known exposure modifying factors: better with otc medications and associated signs and symptoms included fever, post nasal drainage, cough, malaise, chine, vomiting.Patient's weight upon visit was included bpsystolic/ diastolic: 130/78 mmhg.Temperature; 97,8 f.Pulse: 72/min, respiration:15/min.Patient's review of system on visit showed constitutional: fatigue (positive), fever (positive), malaise (positive); heent: nasal congestion (positive), sore throat (positive); respiratory: cough (positive), chest congestion (negative), shortness of breath (negative); gastroenterology; abdominal pain (negative); skin: rash (negative), skin lesion (negative).Patient's physical exam showed general: appearance: mildly ill appearing, no acute distress, tired appearing, nourishment: well nourished, hydration: well hydrated; heent: eyes: pupils round and reactive, conjunctiva clear, ear canals: the ear canals are free of abnormal discharges and impactions, tympanic membranes: dull, nasal mucosa: nasal congestion, pharynx: cobblestoning; head & neck: heed adult: normocephalic, atrarnautic, neck: the neck is supple, no lymphacienopathy, thyroid: there is no palpable thyromegaly nor thyroid nodule, carotid bruit(s): without audible carotid bruits; respiratory: inspection: breathing easily, symmetrical expansion, no deformities, rate/pattern: with a normal respiration rate and pattern, breath sounds: there are normal breath sounds present, no rales, rhonchi, or wheezing; cardiovascular: heart rate: a normal heart rate, cardiac rhythm: there is a regular rhythm, murmur: no murmurs, extremities: no edema; neurologic: general: alert and oriented x 3, mood and affect appropriate for age, gait: normal; skin: general: no rashes, ecchymosis, petechlae, or lesions noted.Corrective treatment: er, wheelchair, crutches, cane user for couldn't get out of the bed/ unable to get out of bed; wheelchair, crutches, cane user for limping; oral steroid, antibiotics for k knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen; oral steroid, tylenol, antibiotics for the the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe10 on scale of 1-10; oral steroid for knee started feeling stiff; oral steroid, took out 4 large syringes of fluid, antibiotics for took out 4 large syringes of fluid; wheel chair, crutches, antibiotics for knee redness/ red; not reported for couldn't put one ounce of weight on knee and white blood count elevated, warm to touch, leg swelling; oseltamivir phosphate (tamiflu), otc medications for influenza a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51927 the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Outcome: recovered for and knee redness/ red; unknown for warm to touch, leg swelling, influenza; not recovered for others seriousness criteria: disability for couldn't get out of the bed/ unable to get out of bed, limping; required intervention for knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen, the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe10 on scale of 1-10, knee started feeling stiff and took out 4 large syringes of fluid additional information was received on 29-jan-2018 from the patient.Event of knee redness was added.Event of knee swelled bad/it was so big was updated to knee swelled bad/it was so big/severe knee swelling; the pain was bad/ incredible amount of pain was updated to the pain was bad/ incredible amount of pain/insufferable pain.Concomitant medications and medical history was added.Clinical course was updated and text amended accordingly additional information was received on 02-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 09-feb-2018 from patient.Additional event of white blood count elevated was added.Event terms were updated: from knee swelled bad/it was so big/severe knee swelling to knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee; from the pain was bad/ incredible amount of pain/insufferable pain to the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain and from couldn't get out of the bed to couldn't get out of the bed/ unable to get out of bed.Clinical course was updated.Text was amended accordingly.Additional information was received on 28-feb-2018 from other non-healthcare professional (outside counsel).Additional event of leg swelling, warm to touch and influenza were added with details.Symptoms of knee pain were added.Patient's medical history, family history, concomitant medication were added.Event term of the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain was updated to the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe10 on scale of 1-10; knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee was updated to knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen and their outcome was updated to not recovered.Clinical course was updated.Text was amended accordingly.Additional information was received on 07-mar-2018.Medical history and past drugs were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 28-feb-2018: the follow-up information received does not alter the overall case assessment.This case concerns a patient who after receiving synvisc one injection experienced mobility decreased, limping disability and underwent intervention due to right knee swelling, pain, stiffness and knee effusion.He also experienced injection site erythema and weight bearing difficulties.The temporal relationship can be established between the events and the suspect product based on the available information.Therefore, pharmacological plausibility of the events to the product cannot be excluded.Moreover, lack of information regarding the lot number, patient's relevant medical history and concurrent conditions makes the complete case assessment difficult.

Event Description

This spontaneous case from united states was received on 11-jan-2018 from the patient.This case concerns a 48 years old male patient who initiated treatment with synvisc one and after few hours had knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen, knee redness/ red, the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe10 on scale of 1-10, knee started feeling stiff, couldn't get out of the bed/ unable to get out of bed, on the same day experienced leg swelling, warm to touch.On the next day, doctor took out 4 large syringes of fluid and patient had white blood count elevated (01 day later).Patient was limping and couldn't put one ounce of weight on knee/ unable to bear weight due to pain after an unknown latency of receiving synvisc one, 61 days later experienced influenza and a device malfunction was noted in reported lot number.Concomitant medications: lisinopril, hydrocodone, hydrochlorothiazide, cyclobenzaprine, prednisone, amoxicillin, alprazolam (xanax), fluoxetine hydrochloride.Medical history included: right knee surgery, wrist bone tumor (benign distal radial bone left wrist) (2007), benign tumor distal radial bone forearm (2007) and high elevated blood pressure, allergic rhinitis, acute pharyngitis, pain in wrist, ganglion of joint, sprain of wrist, otitis externa, fatigue, cellulitis and abscess of unspecified site, anxiety, essential (primary) hypertension, left low back pain, unspecified chronicity, with sciatica presence unspecified.The patient was a nonsmoker.The patient had no known drug allergies.The patient had depression (the onset of the depression had been variable and had been occurring in a persistent pattern for months.The course had been increasing.The depression was described as feeling blue, sad, nervous and tired.The symptoms had been associated with marital problems).The patient's medical history also included wrist mass (the wrist mass was characterized as a localized.The wrist mass described as located in the dorsal radial.The wrist mass was aggravated by any movement relieving factors include rest) and neck mass (the onset of the mass had been gradual (swollen lump on left side of neck) and had been occurring in a persistent pattern for 1 week.The course had been increasing, the mass was described as moderate.Neck mass notes: swells more at night.Patient started taking his wife's antibiotics and his symptoms were improving).The patient also had anxiety.As of (b)(6) 2009, it was reported that the onset of the anxiety, had been gradual and had been occurring in a persistent pattern for 10 weeks.The course had been increasing.The anxiety was characterized as nervousness.There are no specific phobias.The symptoms had been associated with agitation and insomnia.As of (b)(6) 2014, it was reported that the onset of the anxiety had been sudden and had been occurring in a persistent pattern for 2 days.The course has been increasing.The anxiety was characterized as apprehension, expectant dread, sinking feeling, nervousness, extreme fear and there are no specific phobias.Precipitating factors include: (relationship issue).The symptoms had been associated with feeling of sadness and insomnia.As of (b)(6) 2011, the patient had a complaint of injury.The injury occurred when (5-29-11 was getting off the wave runner and scrapped his left leg on his trailer.He was in the water at the time.Patient had a large black and green bruise on the left calf.No swelling or drainage.There were 4 scratches noted, areas were scabbed over.No drainage.The injury occurred 3 days ago.The course had been decreasing.The injury was described as mild.The injury described as being located in the left leg (calf).The patient's medical history also included pain.The onset of the pain had been sudden and had been occurring in a persistent pattern for 2 days.The course had been constant.The pain was characterized as shooting and burning.The pain described as located in the lower back.The pain does not radiate.The symptoms were relieved by lying down.The pain had been associated with back stiffness.Pain: patient was playing basketball when injury happened.The patient also had complaint of ear pain.The onset of the pain had been sudden and had been occurring in a persistent pattern for 2 clays.The course had been increasing.The pain was described as a moderate dull aching and pressure, the pain described as being located in the inner ear.The pain was felt in the left ear.The symptoms had been associated with decreased hearing.Patient's hypertension symptoms included headache and shortness of breath.It was reported that recent blood pressure has been mostly < 190/100s.The patient describes this as moderate in severity and improving, symptoms are exacerbated by weight gain.Associated symptoms include weakness.Note for "hypertension": pt had not been taking his blood pressure medication, all reports from jph all normal, he has been inking medication since.Blood pressure running 138-191/88-117.The patient had possible kidney infection onset: (b)(6) 2017; quality: aching, sharp, pressure timing: sudden onset severity: severe.At the time of visit on (b)(6) 2017, it was reported that the patient had a history of low back pain and he had some discomfort for a couple of days but a few hours ago he started having a severe sharp pain in his left lower back.He had not done anything out of the ordinary but he did lift weights regularly.The patient had been sleeping poorly and had decreased energy level.The patient had allergy (iodinated contrast).The patient was alcoholic.Patient's family history included colon cancer.Mother; lung cancer.Father; asthma.Brother.On (b)(6) 2017, patient presented with right knee pain which got stirred up while playing basket-ball a couple of weeks ago, happened earlier but pain went away after resting but this time, it never let -up, underwent mri scan of right knee: showed irregularity of the medial femoral condyle of the articular surface but no evidence of osteonecrosis and no evidence of medical meniscal tear.Steroid injection was given.Felt better but not 100%.On (b)(6) 2016, showed no effusion and full range motion in knee.On(b)(6) 2016, patient again presented with request of steroid injection.Went on vacation, had minor twisting injury to the knee, had increasing pain.Underwent steroid injection depo medrol with lidocaine and marcaine in right knee.On (b)(6) 2016, persistent pain, while playing golf, he tweaked and had sharp stabbing pain in medial joint.Mri showed degeneration of medial meniscus as well as joint space narrowing and bruising of medical tibial plateau.Had couple of cortisone injection, provide temporary relief.No swelling or effusion today.Arthroscopy recommended.On (b)(6) 2016 , patient underwent arthroscopic medical meniscectomy for internal derangement of right knee and primary osteoarthritis.Patient developed rash around his right knee.On (b)(6) 2016, was in football game, and fell suffering a contusion to the anteromedial aspect of the right knee and had some medial knee pain since.X-ray was normal.Started medication vimovo.Had right elbow pain despite no specific injury, which worse at night increased pain with gripping, had exquisite tenderness to palpation over the lateral epicondyle.Patient had steroid injection (depo medrol with lidocaine and marcaine) on knee and right elbow, wear tennis elbow strap for symptomatic relief with activity.On (b)(6) 2017 had knee effusion, was tender at the medical joint, have some mild crepitation with motion.Injected with methylprednisolone acetate (depo-medrol) and some bupivacaine hydrochloride (marcaine).On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df (1 shot) once for osteoarthritis and knee pain (batch/ lot number: 7rsl021 and expiry date: unknown) in right knee.On the same day, at 11:00 am, patient had last dose prior to the problem starting.On the same day after a few hours, patient's knee was hurting, it was red he couldn't get out of bed, his knee swelled badly and started feeling stiff.Patient reported that at about 0830 in the night it started swelling and it became very sore.The same day, patient had severe swelling in the right knee, extreme pain and was unable to get out of bed.The patient need urgent care clinic and referred to emergency room.The same day, the patient experienced knee pain (location: right knee; quality: painful, cramping, shooting timing: constant severity: severe, 10 on scale of 1-10 associated signs & symptoms: leg swelling +, warm to touch, red) the patient stated that he never had that shot before.He further stated that he had some pain medication at home, he says that he took two around 0700am in the morning of (b)(6) 2018 and was still in severe pain.He stated that they have been icing it all night.On (b)(6) 2018 the next day, patient went to the er where the doctor took out 4 large syringes of fluid.The patient was in the er for several hours.They did a white blood cell count change and cultured the fluid.The same day, the patient experienced swelling of right knee joint.That day, (latency: 01 day) blood count/panel revealed elevated white blood count and was in emergency room (er) for several hours.The patient did consult the health care professional and seen in person.Patient did visit the emergency room for the problems.The doctor prescribed a dose of antibiotics/considered surgery (knee washout).Drained knee several times with syringe.Patient was given a high level steroid orally.The patient took tylenol as well.Patient's review of system on visit showed constitutional: fatigue (-), weight gain (-), weight loss (-); heent: nasal congestion (-); gastroenterology: constipation (-), diarrhea (-), vomiting (-), nausea (-), abdominal pain (-); musculoskeletal: joint pain (+); skin: rash (-), skin lesion (-).The physical exam showed general: appearance: appears well, tired appearing; respiratory: inspection: breathing easily, symmetrical expansion, no deformities, rate/pattern: with a normal respiration rate and pattern; cardiovascular: heart rate: a normal heart rate, cardiac rhythm: there is a regular rhythm; musculoskeletal: general a right knee swollen; stated unable to bear weight due to pain; neurologic: general: alert and oriented x 3, mood and affect appropriate for age, gait: wheelchair; skin: general: no rashes, ecchymosis, petechise, or lesions noted.The patient was prescribed ciprofloxacin on (b)(6) 2018.The patient had to use a wheelchair the day after getting the shot and then moved to where he was using crutches (onset: (b)(6) 2017; latency: unknown).He had an incredible amount of pain.Then he was limping for a while.The patient couldn't put one ounce of weight on my knee (onset: (b)(6)2017; latency: unknown).On (b)(6)2018, 61 days after initiating treatment, the patient was diagnosed with influenza.The patient also had sudden respiratory illness symptoms of head congestion, runny nose, cough, sinus pressure (duration: 1 day progression; worsening severity: moderate).It was reported that the patient had no known exposure modifying factors: better with otc medications and associated signs and symptoms included fever, post nasal drainage, cough, malaise, chine, vomiting.Patient's weight upon visit was included bp-systolic/diastolic: 130/78 mmhg.Temperature; 97,8 f.Pulse: 72/min, respiration:15/min.Patient's review of system on visit showed constitutional: fatigue (positive), fever (positive), malaise (positive); heent: nasal congestion (positive), sore throat (positive); respiratory: cough (positive), chest congestion (negative), shortness of breath (negative); gastroenterology; abdominal pain (negative); skin: rash (negative), skin lesion (negative).Patient's physical exam showed general: appearance: mildly ill appearing, no acute distress, tired appearing, nourishment: well nourished, hydration: well hydrated; heent: eyes: pupils round and reactive, conjunctiva clear, ear canals: the ear canals are free of abnormal discharges and impactions, tympanic membranes: dull, nasal mucosa: nasal congestion, pharynx: cobblestoning; head & neck: heed adult: normocephalic, atrarnautic, neck: the neck is supple, no lymphacienopathy, thyroid: there is no palpable thyromegaly nor thyroid nodule, carotid bruit(s): without audible carotid bruits; respiratory: inspection: breathing easily, symmetrical expansion, no deformities, rate/pattern: with a normal respiration rate and pattern, breath sounds: there are normal breath sounds present, no rales, rhonchi, or wheezing; cardiovascular: heart rate: a normal heart rate, cardiac rhythm: there is a regular rhythm, murmur: no murmurs, extremities: no edema; neurologic: general: alert and oriented x 3, mood and affect appropriate for age, gait: normal; skin: general: no rashes, ecchymosis, petechlae, or lesions noted.Corrective treatment: er, wheelchair, crutches, cane user for couldn't get out of the bed/ unable to get out of bed; wheelchair, crutches, cane user for limping; oral steroid, antibiotics for k knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen; oral steroid, tylenol, antibiotics for the the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe10 on scale of 1-10; oral steroid for knee started feeling stiff; oral steroid, took out 4 large syringes of fluid, antibiotics for took out 4 large syringes of fluid; wheel chair, crutches, antibiotics for knee redness/ red; not reported for device malfunction, couldn't put one ounce of weight on knee and white blood count elevated, warm to touch, leg swelling; oseltamivir phosphate (tamiflu), otc medications for influenza a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51927 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 outcome: recovered for and knee redness/ red; unknown for warm to touch, leg swelling, influenza; not recovered for others seriousness criteria: disability for device malfunction, couldn't get out of the bed/ unable to get out of bed, limping; required intervention for knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen, the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe10 on scale of 1-10, knee started feeling stiff and took out 4 large syringes of fluid additional information was received on 29-jan-2018 from the patient.Event of knee redness was added.Event of knee swelled bad/it was so big was updated to knee swelled bad/it was so big/severe knee swelling; the pain was bad/ incredible amount of pain was updated to the pain was bad/ incredible amount of pain/insufferable pain.Concomitant medications and medical history was added.Clinical course was updated and text amended accordingly additional information was received on 02-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 09-feb-2018 from patient.Additional event of white blood count elevated was added.Event terms were updated: from knee swelled bad/it was so big/severe knee swelling to knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee; from the pain was bad/ incredible amount of pain/insufferable pain to the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain and from couldn't get out of the bed to couldn't get out of the bed/ unable to get out of bed.Clinical course was updated.Text was amended accordingly.Additional information was received on 28-feb-2018 from other non-healthcare professional (outside counsel).Additional event of leg swelling, warm to touch and influenza were added with details.Symptoms of knee pain were added.Patient's medical history, family history, concomitant medication were added.Event term of the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain was updated to the pain was bad/ incredible amount of pain/insufferable pain/ extreme pain/ right knee pain/ painful, cramping, shooting, constant, severe10 on scale of 1-10; knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee was updated to knee swelled bad/it was so big/severe knee swelling/ severe swelling in right knee/ started swelling/ right knee swollen and their outcome was updated to not recovered.Clinical course was updated.Text was amended accordingly.Additional information was received on 07-mar-2018.Medical history and past drugs were added.Text was amended accordingly.Additional information was received on 28-mar-2018 from patient.Suspect drug synvisc one batch/lot number added.Additional event of device malfunction was added.Medical history added.Investigation summary information updated.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 28-mar-2018: after receiving synvisc one injection of recalled lot patient experienced mobility decreased, limping disability and underwent intervention due to right knee swelling, pain, stiffness and knee effusion.He also experienced injection site erythema and weight bearing difficulties.The temporal relationship can be established between the events and the suspect product based on the available information.Therefore, pharmacological plausibility of the events to the product cannot be excluded.Moreover, as the concerned lot number has been identified to have malfunction by the company, so a causal role of the drug for the occurrence of the events cannot be excluded.

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Brand Name

SYNVISC ONE

Type of Device

INTRA-ARTICULAR HYALURONIC ACID

Manufacturer (Section D)

GENZYME BIOSURGERY (RIDGEFIELD)

1125 pleadantview terrace

ridgefield NJ 07657

MDR Report Key

7224092

MDR Text Key

98413665

Report Number

2246315-2018-00165

Device Sequence Number

Product Code

MOZ

Combination Product (y/n)

PMA/PMN Number

P940015

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer

Remedial Action

Recall

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Other

Device Lot Number

7RSL021

Was Device Available for Evaluation?

Was the Report Sent to FDA?

Initial Date Manufacturer Received

01/11/2018

Initial Date FDA Received

01/29/2018

Supplement Dates Manufacturer Received

01/29/2018
02/02/2018
02/09/2018
02/28/2018
03/07/2018
03/28/2018

Supplement Dates FDA Received

02/15/2018
02/21/2018
03/03/2018
03/12/2018
03/21/2018
04/20/2018

Patient Sequence Number

Treatment

AMOXICILLIN(CON.)-START; AMOXICILLIN(CON.)-START; AMOXICILLIN(CON.)-START; AMOXICILLIN(CON.)-STOP; AMOXICILLIN(CON.)-STOP -UNKNOWN; AMOXICILLIN(CON.)-STOP -UNKNOWN; CYCLOBENZAPRINE(CON.); CYCLOBENZAPRINE(CON.); CYCLOBENZAPRINE(CON.); DEPO-MEDROL(PREV.); DEPO-MEDROL(PREV.); FLUOXETINE HYDROCHLORIDE(CON.); FLUOXETINE HYDROCHLORIDE(CON.); FLUOXETINE HYDROCHLORIDE(CON.); HYDROCHLOROTHIAZIDE(CON.); HYDROCHLOROTHIAZIDE(CON.); HYDROCHLOROTHIAZIDE(CON.); HYDROCODONE(CON.); HYDROCODONE(CON.); HYDROCODONE(CON.); HYDROCODONE(CON.); HYDROCODONE(CON.); HYDROCODONE(CON.); LISINOPRIL(CON.) - START (ONGOING); LISINOPRIL(CON.) - START (ONGOING); LISINOPRIL(CON.) - START (ONGOING); LISINOPRIL(CON.) - START (ONGOING); LISINOPRIL(CON.) - START (ONGOING); LISINOPRIL(CON.) - START (ONGOING); MARCAINE(PREV.); MARCAINE(PREV.); PREDNISONE(CON.); PREDNISONE(CON.); PREDNISONE(CON.); XANAX(CON.); XANAX(CON.); XANAX(CON.)

Patient Outcome(s)

Required Intervention; Disability;

Patient Age

48 YR

Patient Weight

117

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

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