MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

Lot Number CRSP019B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Pain (1994); Myalgia (2238); Arthralgia (2355); Ambulation Difficulties (2544); Ankylosis (4527); Muscle/Tendon Damage (4532); Injection Site Reaction (4562); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/23/2023

Event Type Injury

Event Description

Mobility is still very limited [mobility decreased] pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain [unilateral leg pain] ([condition aggravated]) when she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking [difficulty in walking] swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling [injection site joint swelling] ([condition aggravated]) experiencing pain from the back of her knee (left knee)/began to experience increased pain [injection site joint pain] ([condition aggravated]) back hurts/began to experience increased pain [back pain aggravated] case narrative: initial information was received from united states on 06-jul-2023 regarding an unsolicited valid serious case from a patient.The case is linked with 2023sa209776(same patient; non company drug- orthovisc treatment) this case involves a 77 years old female patient who first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking, back hurts/began to experience increased pain, pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain, mobility was still very limited , swelling was mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment included orthovisc which she received for her right knee 2 or 3 different times with no problem.The patient's past medical history, concomitant(s) and family history were not provided.On (b)(6) 2023, the patient received 3rd injection of the serious of hylan g-f 20, sodium hyaluronate injection of strength 16 mg/2 ml in the left knee at a dose of 16 mg 1x (once)(lot, expiry date, route - unknown) for osteoarthritis.Information on the batch number was requested.Patient received orthovisc treatments to her right knee 2 or 3 different times with no problem.This time, when doing the left knee, she chose synvisc because it was $8 cheaper, and she thought it would be the same.She received the first 2 injections 1 week apart.The third injection she received 2 weeks after the second because she was out of town.She received the third injection on (b)(6) 2023.The patient reports that she received 3 synvisc shots which were administered by her doctor; the last shot was at the end of (b)(6) 2023 reports that a week later on (b)(6) 2023; latency 7 days she developed pain in her leg, her knee became swollen, and her back hurts(back pain).She reports that she gets pain all the way down to her ankle.She was using hot pads every day and uses ibuprofen; states she was still in pain; it was difficult for her to walk.The patient would like to discuss synvisc adverse reactions; asks what should she do? mis (abbreviation not available) attempted to transfer to synvisc-trained mis.Mis discussed pharmacokinetics (consumer asks how long synvisc stays in her system) and pseudosepsis srds (standard reference documents).Referred to hcp (healthcare professional).Upon call-back, a few days after the third dose, she began to experience increased pain and swelling(injection site joint swelling) (condition aggarvated)(injection site joint pain) (condition aggarvated).Her doctor did an ultrasound after 2 weeks to rule out a blood clot.At that time, he wanted to give her an ia (intra-articular) cortisone injection, but she declined because she was afraid to get another injection.At this point, she was experiencing pain from the back of her knee, all the way down her calf (pain in extremity) (condition aggarvated).The swelling was mostly in the back of her knee.She states that her mobility was still very limited (mobility decreased), although the swelling has decreased some.She states that when she first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking (gait disturbance).She requires rest and elevation of the limb after just a few minutes of walking around her house.She was currently sitting on her couch, with her left leg elevated and a cortisone 5% patch on the back of her knee and a hot pad on the front.She was taking ibuprofen 800mg routinely.Action taken: not applicable for all events corrective treatment: the patient was treated with cortisone patches for gait disturbance, mobility decreased, pain in extremity, injection site joint swelling and injection site joint pain and used hot pads every day and ibuprofen for pain in extremity, back pain, injection site joint swelling and injection site joint pain; rest and elevation of limb for gait disturbance and mobility decreased at time of reporting, the outcome was not recovered / not resolved for all events except recovering for injection site joint swelling seriousness criteria: intervention required for gait disturbance, mobility decreased, injection site joint swelling and injection site joint pain, pain in extremity a product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc (lot/batch number: unknown) with global ptc number: 100342242 the sample status of the ptc was not available, and ptc was set in process the final investigation was not yet completed (till 10-jul-2023), it was set in process.Additional information was received on 06-jul-2023 by quality department: ptc number added.Strength was added, upon retrospective view case was updated to serious, corresponding field updated; text amended.

Event Description

Mobility is still very limited [mobility decreased] pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain [unilateral leg pain] ([condition aggravated]) when she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking [difficulty in walking] swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling [injection site joint swelling] ([condition aggravated]) experiencing pain from the back of her knee (left knee)/began to experience increased pain [injection site joint pain] ([condition aggravated]) back hurts/began to experience increased pain [back pain aggravated] case narrative: initial information was received from united states on 06-jul-2023 regarding an unsolicited valid serious case from a patient.The case is linked with (b)(4) (same patient; non company drug- orthovisc treatment) this case involves 77 years old female patient who first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking, back hurts/began to experience increased pain, pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain, mobility was still very limited , swelling was mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment included orthovisc which she received for her right knee 2 or 3 different times with no problem.The patient's past medical history, concomitant(s) and family history were not provided.On (b)(6) 2023, the patient received 3rd injection of the serious of hylan g-f 20, sodium hyaluronate injection of strength 16 mg/2 ml in the left knee at a dose of 16 mg 1x (once) (lot, expiry date, route - unknown) for osteoarthritis.Information on the batch number was requested.Patient received orthovisc treatments to her right knee 2 or 3 different times with no problem.This time, when doing the left knee, she chose synvisc because it was (b)(6) cheaper, and she thought it would be the same.She received the first 2 injections 1 week apart.The third injection she received 2 weeks after the second because she was out of town.She received the third injection on (b)(6) 2023.The patient reports that she received 3 synvisc shots which were administered by her doctor; the last shot was at the end of (b)(6) 2023 reports that a week later on (b)(6) 2023; latency 7 days she developed pain in her leg, her knee became swollen, and her back hurts(back pain).She reports that she gets pain all the way down to her ankle.She was using hot pads every day and uses ibuprofen; states she was still in pain; it was difficult for her to walk.The patient would like to discuss synvisc adverse reactions; asks what should she do? mis (abbreviation not available) attempted to transfer to synvisc-trained mis.Mis discussed pharmacokinetics (consumer asks how long synvisc stays in her system) and pseudosepsis srds (standard reference documents).Referred to hcp (healthcare professional).Upon call-back, a few days after the third dose, she began to experience increased pain and swelling(injection site joint swelling) (condition aggarvated)(injection site joint pain) (condition aggarvated).Her doctor did an ultrasound after 2 weeks to rule out a blood clot.At that time, he wanted to give her an ia (intra-articular) cortisone injection, but she declined because she was afraid to get another injection.At this point, she was experiencing pain from the back of her knee, all the way down her calf (pain in extremity) (condition aggarvated).The swelling was mostly in the back of her knee.She states that her mobility was still very limited (mobility decreased), although the swelling has decreased some.She states that when she first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking (gait disturbance).She requires rest and elevation of the limb after just a few minutes of walking around her house.She was currently sitting on her couch, with her left leg elevated and a cortisone 5% patch on the back of her knee and a hot pad on the front.She was taking ibuprofen 800mg routinely.Action taken: not applicable for all events corrective treatment: the patient was treated with cortisone patches for gait disturbance, mobility decreased, pain in extremity, injection site joint swelling and injection site joint pain and used hot pads every day and ibuprofen for pain in extremity, back pain, injection site joint swelling and injection site joint pain; rest and elevation of limb for gait disturbance and mobility decreased at time of reporting, the outcome was not recovered / not resolved for all events except recovering for injection site joint swelling seriousness criteria: intervention required for gait disturbance, mobility decreased, injection site joint swelling and injection site joint pain, pain in extremity a product technical complaint (ptc) was initiated on 06-jul-2023 for synvisc (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc stated: complaint: adverse event preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.Investigation the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 01-aug-2023 with summarized conclusion as no assessment possible.Additional information was received on 06-jul-2023 by quality department: ptc number added.Strength was added, upon retrospective view case was updated to serious, corresponding field updated; text amended additional information was received on 01-aug-2023 from healthcare professional (quality department).Ptc results were added.Text amended accordingly.

Event Description

Mobility is still very limited [mobility decreased] pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain [unilateral leg pain] ([condition aggravated]).When she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking/unable to walk [difficulty in walking].Swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling [injection site joint swelling] ([condition aggravated]).Experiencing pain from the back of her knee (left knee)/began to experience increased pain/there was just a little pain [injection site joint pain] ([condition aggravated]) redness [injection site joint redness].Back hurts/began to experience increased pain [back pain aggravated].Case narrative: initial information was received from united states on 06-jul-2023 regarding an unsolicited valid serious case from a patient.The case is linked with (b)(4) (same patient; non company drug- orthovisc treatment).This case involves 77 years old female patient who first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking/unable to walk, back hurts/began to experience increased pain, pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain/ there was just a little pain, redness mobility was still very limited , swelling was mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment included orthovisc which she received for her right knee 2 or 3 different times with no problem.The patient's past medical history, concomitant(s) and family history were not provided.On (b)(6) 2023, the patient received 3rd injection of the serious of hylan g-f 20, sodium hyaluronate injection of strength 16 mg/2 ml in the left knee at a dose of 16 mg 1x (once) (lot, expiry date, route - unknown) for osteoarthritis.Information on the batch number was requested.Patient received orthovisc treatments to her right knee 2 or 3 different times with no problem.This time, when doing the left knee, she chose synvisc because it was $8 cheaper, and she thought it would be the same.She received the first 2 injections 1 week apart.The third injection she received 2 weeks after the second because she was out of town.She received the third injection on (b)(6) 2023.The patient reports that she received 3 synvisc shots which were administered by her doctor; the last shot was at the end of (b)(6) 2023 reports that a week later on (b)(6) 2023; latency 7 days she developed pain in her leg, her knee became swollen, and her back hurts(back pain).She reports that she gets pain all the way down to her ankle.She was using hot pads every day and uses ibuprofen; states she was still in pain; it was difficult for her to walk.The patient would like to discuss synvisc adverse reactions; asks what should she do? mis (abbreviation not available) attempted to transfer to synvisc-trained mis.Mis discussed pharmacokinetics (consumer asks how long synvisc stays in her system) and pseudosepsis srds (standard reference documents).Referred to hcp (healthcare professional).Upon call-back, a few days after the third dose, she began to experience increased pain and swelling(injection site joint swelling) (condition aggarvated)(injection site joint pain) (condition aggarvated).Her doctor did an ultrasound after 2 weeks to rule out a blood clot.At that time, he wanted to give her an ia (intra-articular) cortisone injection, but she declined because she was afraid to get another injection.At this point, she was experiencing pain from the back of her knee, all the way down her calf (pain in extremity) (condition aggarvated).The swelling was mostly in the back of her knee.She states that her mobility was still very limited (mobility decreased), although the swelling has decreased some.She states that when she first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking (gait disturbance).She requires rest and elevation of the limb after just a few minutes of walking around her house.She was currently sitting on her couch, with her left leg elevated and a cortisone 5% patch on the back of her knee and a hot pad on the front.She was taking ibuprofen 800mg routinely.Further upon follow-up, on an unknown date (latency: unknown), the patient stated there was just a little pain but she didn't expect the redness (injection site joint erythema), swelling, unable to walk and having to put the hot bath on her for a few minutes.Action taken: not applicable for all events.Corrective treatment: the patient was treated with cortisone patches for gait disturbance, mobility decreased, pain in extremity, injection site joint swelling and injection site joint pain and injection site joint erythema; used hot pads every day and ibuprofen for pain in extremity, back pain, injection site joint swelling and injection site joint pain; rest and elevation of limb for gait disturbance and mobility decreased.At time of reporting, the outcome was unknown for injection site joint erythema; recovering for injection site joint swelling and not recovered / not resolved for all other events.Seriousness criteria: intervention required for gait disturbance, mobility decreased, injection site joint swelling, injection site joint erythema and injection site joint pain, pain in extremity a product technical complaint (ptc) was initiated on 06-jul-2023 for synvisc (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc stated: complaint: adverse event preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.Investigation the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 01-aug-2023 with summarized conclusion as no assessment possible.Additional information was received on 06-jul-2023 by quality department: ptc number added.Strength was added, upon retrospective view case was updated to serious, corresponding field updated; text amended.Additional information was received on 01-aug-2023 from healthcare professional (quality department).Ptc results were added.Text amended accordingly.Additional information was received on 14-aug-2023 from patient: new event (injection site joint erythema) added.Verbatim of event injection site joint pain and gait disturbance updated.Text was amended accordingly.

Event Description

Mobility is still very limited [mobility decreased].Strain of left calf muscle [muscle strain].Pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain [unilateral leg pain] ([condition aggravated]).Complex tear involving the body and posterior horn of the medial meniscus with peripheral [meniscus injury].When she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking/unable to walk/hard to walk/ every five minutes she has to sit down [difficulty in walking].Redness/left knee redness [injection site joint redness].Swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling/left knee swelling/ brought back the swelling [injection site joint swelling] ([condition aggravated]).Stiff leg (unable to bend left knee) [stiff knees] ([joint range of motion decreased]).Experiencing pain from the back of her knee (left knee)/began to experience increased pain/there was just a little pain [injection site joint pain] ([condition aggravated]).Fluid in knee [injection site joint effusion].Back hurts/began to experience increased pain [back pain aggravated].Case narrative: initial information was received from united states on 06-jul-2023 regarding an unsolicited valid serious case from a patient.The case is linked with (b)(4) (same patient; non company drug- orthovisc treatment), (b)(4) (same patient; non company drug- cortisone treatment), (b)(4) (cluster).This case involves 77 years old female patient whose mobility was still very limited, strain of left calf muscle, pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain, complex tear involving the body and posterior horn of the medial meniscus with peripheral, when she first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking/unable to walk/hard to walk/ every five minutes she has to sit down, swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling/left knee swelling/ brought back the swelling, stiff leg (unable to bend left knee), experiencing pain from the back of her knee (left knee)/began to experience increased pain/there was just a little pain, redness/left knee redness, fluid in knee and back hurts/began to experience increased pain while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, vaccination(s), concomitant medications was not provided.At the time of the event, the patient had ongoing acute pain of left knee, primary osteoarthritis of left knee, and minimal housework seated many time day, pain from knee to ankle when walking after 5 mins.Patient received orthovisc (autovisc) treatments to her right knee 2 or 3 different times (few years ago) with no problem /no adverse reaction with orthovisc 3 injections.Helped lubricate right knee till present time.Patient never had a problem, just a little pain so decided to lubricate left knee.This time, when doing the left knee, she chose synvisc because it was dollar 8 cheaper, and she thought it would be the same.She received the first 2 injections 1 week apart (on (b)(6) 2023 at a dose of 8mg).The third injection she received 2 weeks after the second because she was out of town.On (b)(6) 2023, the patient received 3rd injection of the series of hylan g-f 20, sodium hyaluronate of strength 16 mg/2 ml in the left knee via ultrasound technique at a dose of 8 mg 1x (once) (batch number: crsp019b, expiry date: 30-sep-2025, route - unknown) for osteoarthritis.The patient reports that she received 3 synvisc shots which were administered by her doctor.After the third dose, on (b)(6) 2023 (latency: same day) she began to experience increased pain and swelling (injection site joint swelling, injection site joint pain, condition aggravated).The patient stated there was just a little pain but she didn't expect the redness (injection site joint erythema), swelling, unable to walk and having to put the hot bath on her for a few minutes.Patient had left knee pain, swelling redness, fluid in knee (hard to walk) (injection site joint effusion), stiff leg (unable to bend left knee) (joint stiffness, joint range of motion decreased) (onset: on (b)(6) 2023, latency: same day).She stated that when she first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking (gait disturbance, onset: on (b)(6) 2023, latency: same day).On an unknown date on (b)(6) 2023, (approximately 1 week latency) patient reports that a week later latency: few days she developed pain in her leg, her knee became swollen, and her back hurts (back pain).She reports that she gets pain all the way down to her ankle.She states that her mobility was still very limited (mobility decreased), although the swelling has decreased some.Her doctor did an ultrasound after 2 weeks to rule out a blood clot.At that time, he wanted to give her an ia (intra-articular) cortisone injection, but she declined because she was afraid to get another injection.At this point, she was experiencing pain from the back of her knee, all the way down her calf (pain in extremity) (condition aggravated, onset: on (b)(6) 2023, latency: same day).The swelling was mostly in the back of her knee.She requires rest and elevation of the limb after just a few minutes of walking around her house.She was currently sitting on her couch, with her left leg elevated and a cortisone 5% patch on the back of her knee and a hot pad on the front.She was taking ibuprofen 800mg routinely.She was using hot pads every day and uses ibuprofen; states she was still in pain; it was difficult for her to walk.The patient would like to discuss synvisc adverse reactions; asks what should she do? mis (abbreviation not available) attempted to transfer to synvisc-trained mis.Mis discussed pharmacokinetics (consumer asks how long synvisc stays in her system) and pseudosepsis srds (standard reference documents).Referred to hcp (healthcare professional).On an unknown date in 2023 (latency: few days) mri (magnetic resonance imaging) left knee without contrast was performed with result as complex tear involving the body and posterior horn of the medial meniscus with peripheral (meniscus injury) and also strain of left calf muscle(muscle strain) (onset: 2023; unknown latency).Doctor scheduled a cortisone shot on (b)(6) 2023.The patient could not handle pain and symptom.Patient stated it's been five months and she's suffering terribly from the synvisc shot.She also said that so many people have suffered from the synvisc shot that is a bad reaction of swelling, burning, paining, and the whole leg from the back of her knee all the way down to her calf to her ankle.She's really suffering and always sitting on a hot bath.Patient also stated that the two aspirations performed on her weren't helpful and she was given a cortisone shot and but it was removed because it brought back the swelling and the pain.Patient asked if there's a way of curing the reactions, did any of the people who take the shot had the same reaction, and how have they been treated? she never expected that she'd get a reaction on her good leg with synvisc.Patient said she's suffering so much that every five minutes she has to sit down after putting the heating pad on her knee that's why she called and wanted to know how people got cured.Patient stated she received her last shot if synvisc on (b)(6) 2023, unknown treatment start date for a little discomfort on her knee at the meniscus.She also stated that she made a mistake in choosing synvisc and she paid a lot of money for her co-pay.Relevant laboratory test results included: magnetic resonance imaging joint in 2023: with following result.Medial compartment showed a complex tear is detected in the body and posterior horn of the medial meniscus.The tear has both longitudinal horizontal and vertical components and is associated with peripheral meniscal extrusion.The medial collateral ligament is intact but peripherally bowed by the extruded medial meniscus as well as medial osteophytes.There is high-grade cartilage loss along the weightbearing surfaces of the medial compartment with trace subchondral edema.Lateral compartment showed the lateral meniscus is intact.No displaced meniscal fragments are identified.Examination of the posterolateral corner demonstrates intact biceps femoris tendon, fibular collateral ligament, and popliteus tendon.No focal osteochondral injury is identified.Patellofemoral compartment showed the extensor mechanism is intact.Mild to moderate chondral thinning is observed without significant subchondral edema.No abnormal patellar tilt or subluxation is noted.The medial and lateral retinaculum are intact.Cruciate ligaments showed the anterior and posterior cruciate ligaments are intact with other finding as a moderate joint effusion was identified.There is trace fluid in the expected location of a baker's cyst.Impression illustrated complex tear involving the body and posterior horn of the medial meniscus with peripheral].Ultrasound scan on (b)(6) 2023: [ultrasound was done to rule out a blood clot: unknown results].Action taken: not applicable for all events.Corrective treatment: ibuprofen and used hot pads every day for pain in extremity, injection site joint pain, back pain, injection site joint swelling, injection site joint erythema, cortisone patches for injection site joint swelling, injection site joint pain, gait disturbance, pain in extremity, mobility decreased; advil and methylprednisolone for injection site joint effusion, injection site joint erythema, injection site joint pain, injection site joint swelling, pain in extremity, gait disturbance, joint stiffness, muscle strain; rest and elevation of limb for gait disturbance and mobility decreased; icing for injection site joint swelling and injection site joint pain; pad for injection site joint effusion and gait disturbance and not reported for rest events.Outcome: not recovered for mobility decreased, injection site joint pain , injection site joint erythema , muscle strain, pain in extremity, gait disturbance; unknown for meniscus injury, joint stiffness, injection site joint effusion ; recovering for injection site joint swelling, seriousness criteria: intervention required for mobility decreased; intervention required and disability for joint stiffness , injection site joint swelling , injection site joint pain , injection site joint erythema , muscle strain, injection site joint effusion , pain in extremity, gait disturbance; disability for meniscus injury a product technical complaint (ptc) was initiated on 06-jul-2023 for synvisc.Batch number; crsp019b, expiry date: 30-sep-2025; global ptc number: (b)(4).Sample status of ptc was not available, and ptc stated preliminary assessment: complaint: adverse event preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.Investigation (tj 24jul2023), the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) was required.Reopened investigation due to lot# changed to crsp019b (dp 01nov2023) the production and quality control documentation for lot#: crsp019b, expiration date (2025-09) was manufactured on 27oct2022 packaged (b)(4) kits were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot#, batch record review & lot# frequency analysis for lot#: crsp019b no capa was required.As of 02nov2023, there are 5 complaints on file for lot#: crsp019 and all related sublots.5 complaints are on file for lot#: crsp019b: (1) syringe broken while use/adverse event report, (1) leakage and (3) adverse event reports.Sanofi will continue to monitor complaints and trending to determine if capa (corrective and preventive actions) was required.The final investigation was completed on 03-nov-2023 with summarized conclusion as no assessment possible.Additional information was received on 06-jul-2023 by quality department: ptc number added.Strength was added, upon retrospective view case was updated to serious, corresponding field updated; text amended.Additional information was received on 01-aug-2023 from healthcare professional (quality department).Ptc results were added.Text amended accordingly.Additional information was received on 14-aug-2023 from patient: new event (injection site joint erythema) added.Verbatim of event injection site joint pain and gait disturbance updated.Text was amended accordingly.Additional information was received on 23-aug-2023 from patient: seriousness criteria of event pain in extremity, injection site joint swelling , injection site joint pain updated; event of injection site joint effusion, joint stiffness, meniscus injury , muscle strain added; as reported term and seriousness of event injection site joint erythema updated; as reported of event injection site joint swelling, gait disturbance updated; lab added; medical history updated; treatment added for event injection site joint pain, injection site joint swelling; concomitant added; therapy details updated; onset of all events updated; indication updated; text was amended accordingly.Additional information was received on 07-sep-2023 from patient.Batch number was added.Clinical course was updated.Text amended accordingly.Additional information was received on 01-nov-2023 by quality department from other health care professional: the complaint: (b)(4) has been reopened for the following reason: incomplete complaint information, no new significant information received; text amended.Additional information was received on 03-nov-2023 by quality department from other health care professional: ptc details added; expiry date updated; text amended.Additional information was received on 06-nov-2023 from patient.The event of gait disturbance and injection site joint swelling was updated.Text amended accordingly.

Event Description

Mobility is still very limited [mobility decreased].Strain of left calf muscle [muscle strain].Pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain [unilateral leg pain] ([condition aggravated]).Complex tear involving the body and posterior horn of the medial meniscus with peripheral [meniscus injury].When she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking/unable to walk/hard to walk [difficulty in walking].Redness/left knee redness [injection site joint redness].Swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling/left knee swelling [injection site joint swelling] ([condition aggravated]).Stiff leg (unable to bend left knee) [stiff knees] ([joint range of motion decreased]) experiencing pain from the back of her knee (left knee)/began to experience increased pain/there was just a little pain [injection site joint pain] ([condition aggravated]) fluid in knee [injection site joint effusion] back hurts/began to experience increased pain [back pain aggravated].Case narrative: initial information was received from united states on 06-jul-2023 regarding an unsolicited valid serious case from a patient.The case is linked with (b)(4) (same patient; non company drug- orthovisc treatment).This case involves 77 years old female patient whose mobility is still very limited, strain of left calf muscle, pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain, complex tear involving the body and posterior horn of the medial meniscus with peripheral, when she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking/unable to walk/hard to walk, swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling/left knee swelling, stiff leg (unable to bend left knee), experiencing pain from the back of her knee (left knee)/began to experience increased pain/there was just a little pain, redness/left knee redness, fluid in knee and back hurts/began to experience increased pain while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, vaccination(s), concomitant medications was not provided.At the time of the event, the patient had ongoing acute pain of left knee, primary osteoarthritis of left knee, and minimal housework seated many time day, pain from knee to ankle when walking after 5 mins.Patient received orthovisc treatments to her right knee 2 or 3 different times (few years ago) with no problem /no adverse reaction with orthovisc 3 injections.Helped lubricate right knee till present time.Patient never had a problem, just a little pain so decided to lubricate left knee.This time, when doing the left knee, she chose synvisc because it was dollar 8 cheaper, and she thought it would be the same.She received the first 2 injections 1 week apart (on (b)(6) 2023 at a dose of 8mg).The third injection she received 2 weeks after the second because she was out of town.On (b)(6) 2023, the patient received 3rd injection of the series of hylan g-f 20, sodium hyaluronate of strength 16 mg/2 ml in the left knee via ultrasound technique at a dose of 8 mg 1x (once) (batch number: crsp019b, expiry date: 30-sep-2025, route - unknown) for osteoarthritis.The patient reports that she received 3 synvisc shots which were administered by her doctor.After the third dose, on (b)(6) 2023 (latency: same day) she began to experience increased pain and swelling (injection site joint swelling, injection site joint pain, condition aggravated).The patient stated there was just a little pain but she didn't expect the redness (injection site joint erythema), swelling, unable to walk and having to put the hot bath on her for a few minutes.Patient had left knee pain, swelling redness, fluid in knee (hard to walk ) (injection site joint effusion) , stiff leg (unable to bend left knee) (joint stiffness, joint range of motion decreased) (onset: (b)(6) 2023, latency: same day).She stated that when she first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking (gait disturbance, onset: (b)(6) 2023, latency: same day).On an unknown date in (b)(6) 2023, (approximately 1 week latency) patient reports that a week later latency: few days she developed pain in her leg, her knee became swollen, and her back hurts(back pain).She reports that she gets pain all the way down to her ankle.She states that her mobility was still very limited (mobility decreased), although the swelling has decreased some.Her doctor did an ultrasound after 2 weeks to rule out a blood clot.At that time, he wanted to give her an ia (intra-articular) cortisone injection, but she declined because she was afraid to get another injection.At this point, she was experiencing pain from the back of her knee, all the way down her calf (pain in extremity) (condition aggravated, onset: (b)(6) 2023, latency: same day).The swelling was mostly in the back of her knee.She requires rest and elevation of the limb after just a few minutes of walking around her house.She was currently sitting on her couch, with her left leg elevated and a cortisone 5% patch on the back of her knee and a hot pad on the front.She was taking ibuprofen 800mg routinely.She was using hot pads every day and uses ibuprofen; states she was still in pain; it was difficult for her to walk.The patient would like to discuss synvisc adverse reactions; asks what should she do? mis (abbreviation not available) attempted to transfer to synvisc-trained mis.Mis discussed pharmacokinetics (consumer asks how long synvisc stays in her system) and pseudosepsis srds (standard reference documents).Referred to hcp (healthcare professional).On an unknown date in 2023(latency: few days) mri (magnetic resonance imaging) left knee without contrast was performed with result as complex tear involving the body and posterior horn of the medial meniscus with peripheral (meniscus injury) and also strain of left calf muscle(muscle strain) (onset: 2023; unknown latency).Doctor scheduled a cortisone shot on (b)(6) 2023.The patient could not handle pain and symptom.Relevant laboratory test results included: magnetic resonance imaging joint - in 2023: with following result.Medial compartment showed a complex tear is detected in the body and posterior horn of the medial meniscus.The tear has both longitudinal horizontal and vertical components and is associated with peripheral meniscal extrusion.The medial collateral ligament is intact but peripherally bowed by the extruded medial meniscus as well as medial osteophytes.There is high-grade cartilage loss along the weightbearing surfaces of the medial compartment with trace subchondral edema.Lateral compartment showed the lateral meniscus is intact.No displaced meniscal fragments are identified.Examination of the posterolateral corner demonstrates intact biceps femoris tendon, fibular collateral ligament, and popliteus tendon.No focal osteochondral injury is identified.Patellofemoral compartment showed the extensor mechanism is intact.Mild to moderate chondral thinning is observed without significant subchondral edema.No abnormal patellar tilt or subluxation is noted.The medial and lateral retinaculum are intact.Cruciate ligaments showed the anterior and posterior cruciate ligaments are intact with other finding as a moderate joint effusion was identified.There is trace fluid in the expected location of a baker's cyst.Impression illustrated complex tear involving the body and posterior horn of the medial meniscus with peripheral] ultrasound scan - in (b)(6) 2023: [ultrasound was done to rule out a blood clot: unknown results] action taken: not applicable for all events.Corrective treatment: ibuprofen and used hot pads every day for pain in extremity, injection site joint pain, back pain, injection site joint swelling, injection site joint erythema, cortisone patches for injection site joint swelling, injection site joint pain, gait disturbance, pain in extremity, mobility decreased; advil and methylprednisolone for injection site joint effusion, injection site joint erythema, injection site joint pain, injection site joint swelling, pain in extremity, gait disturbance, joint stiffness, muscle strain; rest and elevation of limb for gait disturbance and mobility decreased; icing for injection site joint swelling and injection site joint pain; pad for injection site joint effusion and gait disturbance and not reported for rest events.Outcome: not recovered for mobility decreased, injection site joint pain , injection site joint erythema , muscle strain, pain in extremity, gait disturbance; unknown for meniscus injury, joint stiffness, injection site joint effusion ; recovering for injection site joint swelling, seriousness criteria: intervention required for mobility decreased; intervention required and disability for joint stiffness , injection site joint swelling , injection site joint pain , injection site joint erythema , muscle strain, injection site joint effusion , pain in extremity, gait disturbance; disability for meniscus injury.A product technical complaint (ptc) was initiated on 06-jul-2023 for synvisc.Batch number; crsp019b, expiry date: 30-sep-2025; global ptc number: 100342242.Sample status of ptc was not available, and ptc stated preliminary assessment: complaint: adverse event preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.Investigation (tj 24jul2023) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) was required.Reopened investigation due to lot# changed to crsp019b - (dp 01nov23) the production and quality control documentation for lot # crsp019b expiration date (2025-09) was manufactured on 27oct22 packaged 8036 kits were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # crsp019b no capa was required.As of 02nov2023 there are 5 complaints on file for lot# crsp019 and all related sublots.5 complaints are on file for lot# crsp019b: (1) syringe broken while use/adverse event report, (1) leakage and (3) adverse event reports.Sanofi will continue to monitor complaints and trending to determine if capa(corrective and preventive actions) was required.The final investigation was completed on 03-nov-2023 with summarized conclusion as no assessment possible additional information was received on 06-jul-2023 by quality department: ptc number added.Strength was added, upon retrospective view case was updated to serious, corresponding field updated; text amended.Additional information was received on 01-aug-2023 from healthcare professional (quality department).Ptc results were added.Text amended accordingly.Additional information was received on 14-aug-2023 from patient: new event (injection site joint erythema) added.Verbatim of event injection site joint pain and gait disturbance updated.Text was amended accordingly.Additional information was received on 23-aug-2023 from patient: seriousness criteria of event pain in extremity, injection site joint swelling , injection site joint pain updated; event of injection site joint effusion, joint stiffness, meniscus injury , muscle strain added; as reported term and seriousness of event injection site joint erythema updated; as reported of event injection site joint swelling, gait disturbance updated; lab added; medical history updated; treatment added for event injection site joint pain, injection site joint swelling; concomitant added; therapy details updated; onset of all events updated; indication updated; text was amended accordingly.Additional information was received on 07-sep-2023 from patient.Batch number was added.Clinical course was updated.Text amended accordingly.Additional information was received on 01-nov-2023 by quality department from other health care professional: the complaint 100342242 has been reopened for the following reason: incomplete complaint information, no new significant information received; text amended.Additional information was received on 03-nov-2023 by quality department from other health care professional: ptc details added; expiry date updated; text amended.

Event Description

Mobility is still very limited [mobility decreased] strain of left calf muscle [muscle strain] pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain [unilateral leg pain] ([condition aggravated]) complex tear involving the body and posterior horn of the medial meniscus with peripheral [meniscus injury] when she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking/unable to walk/hard to walk/ every five minutes she has to sit down [difficulty in walking] redness/left knee redness [injection site joint redness] back hurts/began to experience increased pain [back pain aggravated] swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling/left knee swelling/ brought back the swelling [injection site joint swelling] ([condition aggravated]) stiff leg (unable to bend left knee)/stiffness" following the 3rd & last dose of synvisc [joint stiffness] ([joint range of motion decreased]) experiencing pain from the back of her knee (left knee)/began to experience increased pain/there was just a little pain/experience severe pain [injection site joint pain] ([condition aggravated]) fluid in knee [injection site joint effusion] removed fluid from the knee/left knee aspiration [aspiration of joint] synvisc treatment was ineffective for her condition with no reported adverse event [device ineffective].Case narrative: initial information was received from united states on 06-jul-2023 regarding an unsolicited valid serious case from a patient.The case is linked with (b)(4) (same patient; non company drug- orthovisc treatment), (b)(4)(same patient; non company drug- cortisone treatment), (b)(4) (cluster).This case involves 77 years old female patient whose mobility is still very limited, strain of left calf muscle, pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain, complex tear involving the body and posterior horn of the medial meniscus with peripheral, when she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking/unable to walk/hard to walk/ every five minutes she has to sit down, redness/left knee redness, swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling/left knee swelling/ brought back the swelling, stiff leg (unable to bend left knee)/stiffness" following the 3rd & last dose of synvisc, experiencing pain from the back of her knee (left knee)/began to experience increased pain/there was just a little pain/experience severe pain, fluid in knee, removed fluid from the knee/left knee aspiration, back hurts/began to experience increased pain and synvisc treatment was ineffective for her condition with no reported adverse event while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, vaccination(s), concomitant medications was not provided.At the time of the event, the patient had ongoing acute pain of left knee, primary osteoarthritis of left knee, and minimal housework seated many time day, pain from knee to ankle when walking after 5 mins; left calf pain.Patient received orthovisc (autovisc) treatments to her right knee 2 or 3 different times (few years ago) with no problem /no adverse reaction with orthovisc 3 injections.Helped lubricate right knee till present time.Patient had no previous history of adverse reaction when treated with similar hyaluronic injection, orthovisc in (b)(6) 2021; patient never had a problem, just a little pain so decided to lubricate left knee.Patient had sterile viscoelastic solution synvisc injected aseptically with ultrasound guidence in a multidose (series of 3 total injections) storage as recommended by manufacturer.This time, when doing the left knee, she chose synvisc because it was dollar 8 cheaper, and she thought it would be the same.She received the first 2 injections 1 week apart (on (b)(6) 2023 at a dose of 8mg).The third injection she received 2 weeks after the second because she was out of town.On (b)(6) 2023, the patient received 3rd injection of the series of hylan g-f 20, sodium hyaluronate of strength 16 mg/2 ml in the left knee via ultrasound technique at a dose of 8 mg 1x (once) (batch number: crsp019b, expiry date: 30-sep-2025, route - unknown) for primary osteoarthritis of left knee/left knee advanced osteoarthritis, severe.The patient's left knee joint was prepped using aseptic technique with alcohol and chlorhexadine.The patient was placed in a supine position with knee flexed to 20 degrees.Superficial anesthesia was achieved with ethyl chloride spray.The third dose of synvisc 1 mg was injected using a 22 gauge needle via supralateral approach.The entire procedure was performed using normal aseptic technique.Synvisc was injected into the joint without difficulty.The patient reports that she received 3 synvisc shots which were administered by her doctor.After the third dose, on (b)(6) 2023 (latency: same day) she began to experience increased pain and swelling (injection site joint swelling, injection site joint pain, condition aggravated).The patient stated there was just a little pain but she didn't expect the redness (injection site joint erythema), swelling, unable to walk and having to put the hot bath on her for a few minutes.Patient had left knee pain, swelling redness, fluid in knee (hard to walk) (injection site joint effusion), stiff leg (unable to bend left knee) (joint stiffness, joint range of motion decreased) (onset: (b)(6) 2023, latency: same day).She stated that when she first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking (gait disturbance, onset: (b)(6) 2023, latency: same day).On an unknown date in (b)(6) 2023, (approximately 1 week latency) patient reports that a week later latency: few days she developed pain in her leg, her knee became swollen, and her back hurts (back pain).She reports that she gets pain all the way down to her ankle.She states that her mobility was still very limited (mobility decreased), although the swelling has decreased some.Her doctor did an ultrasound after 2 weeks to rule out a blood clot.At that time, he wanted to give her an ia (intra-articular) cortisone injection, but she declined because she was afraid to get another injection.At this point, she was experiencing pain from the back of her knee, all the way down her calf (pain in extremity) (condition aggravated, onset: (b)(6) 2023, latency: same day).The swelling was mostly in the back of her knee.She requires rest and elevation of the limb after just a few minutes of walking around her house.She was currently sitting on her couch, with her left leg elevated and a cortisone 5% patch on the back of her knee and a hot pad on the front.She was taking ibuprofen 800mg routinely.She was using hot pads every day and uses ibuprofen; states she was still in pain; it was difficult for her to walk.The patient would like to discuss synvisc adverse reactions; asks what should she do? mis (abbreviation not available) attempted to transfer to synvisc-trained mis.Mis discussed pharmacokinetics (consumer asks how long synvisc stays in her system) and pseudosepsis srds (standard reference documents).Referred to hcp (healthcare professional).On an unknown date in 2023(latency: few days) mri (magnetic resonance imaging) left knee without contrast was performed with result as complex tear involving the body and posterior horn of the medial meniscus with peripheral (meniscus injury) and also strain of left calf muscle(muscle strain) (onset: 2023; unknown latency).On (b)(6) 2023; latency: 3 months 20 days, physician, removed liquid from left knee with ultra sound (aspiration joint; intervention required).Doctor scheduled a cortisone shot on (b)(6) 2023.The patient could not handle pain and symptom.On (b)(6) 2023, patient got cortisone injection in left knee she also said that so many people have suffered from the synvisc shot that is a bad reaction of swelling, burning, paining, and the whole leg from the back of her knee all the way down to her calf to her ankle.She's really suffering and always sitting on a hot bath.Patient also stated that the two aspirations performed on her weren't helpful and she was given a cortisone shot and but it was removed because it brought back the swelling and the pain.Patient stated it's been five months and she's suffering terribly from the synvisc shot.Patient reported she continued to experience severe pain , stiffness following the 3rd & last dose of synvisc, indiactive that the synvisc treatment was ineffective for her condition(device ineffective; onset: 2023; latency: few months).Prp injection (platelet -rich plasma) therapy may be beneficial patient said she's suffering so much that every five minutes she has to sit down after putting the heating pad on her knee that's why she called and wanted to know how people got cured.Relevant laboratory test results included: magnetic resonance imaging joint - in 2023: with following result.Medial compartment showed a complex tear is detected in the body and posterior horn of the medial meniscus.The tear has both longitudinal horizontal and vertical components and is associated with peripheral meniscal extrusion.The medial collateral ligament is intact but peripherally bowed by the extruded medial meniscus as well as medial osteophytes.There is high-grade cartilage loss along the weightbearing surfaces of the medial compartment with trace subchondral edema.Lateral compartment showed the lateral meniscus is intact.No displaced meniscal fragments are identified.Examination of the posterolateral corner demonstrates intact biceps femoris tendon, fibular collateral ligament, and popliteus tendon.No focal osteochondral injury is identified.Patellofemoral compartment showed the extensor mechanism is intact.Mild to moderate chondral thinning is observed without significant subchondral edema.No abnormal patellar tilt or subluxation is noted.The medial and lateral retinaculum are intact.Cruciate ligaments showed the anterior and posterior cruciate ligaments are intact with other finding as a moderate joint effusion was identified.There is trace fluid in the expected location of a baker's cyst.Impression illustrated complex tear involving the body and posterior horn of the medial meniscus with peripheral] ultrasound scan - in (b)(6) 2023: [ultrasound was done to rule out a blood clot: unknown results].Action taken: not applicable for all events.Corrective treatment: ibuprofen and used hot pads every day for pain in extremity, injection site joint pain, back pain, injection site joint swelling, injection site joint erythema, cortisone patches and cortisone injection, naperotion(unspecified drug) for injection site joint swelling, injection site joint pain, gait disturbance, pain in extremity, mobility decreased; advil and methylprednisolone for injection site joint effusion, injection site joint erythema, injection site joint pain, injection site joint swelling, pain in extremity, gait disturbance, joint stiffness, muscle strain; rest and elevation of limb for gait disturbance and mobility decreased; icing for injection site joint swelling and injection site joint pain; pad for injection site joint effusion and gait disturbance and not reported for rest events.Outcome: not recovered for mobility decreased, injection site joint pain , joint stiffness , injection site joint erythema , muscle strain, pain in extremity, gait disturbance; unknown for meniscus injury, injection site joint effusion ; recovering for injection site joint swelling.Seriousness criteria: intervention required for aspiration joint, mobility decreased; intervention required and disability for joint stiffness , injection site joint swelling , injection site joint pain , injection site joint erythema , muscle strain, injection site joint effusion , pain in extremity, gait disturbance; disability for meniscus injury.A product technical complaint (ptc) was initiated on 06-jul-2023 for synvisc.Batch number; crsp019b, expiry date: 30-sep-2025; global ptc number: 100342242.Sample status of ptc was not available, and ptc stated preliminary assessment: complaint: adverse event preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.Investigation (tj 24jul2023) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) was required.Reopened investigation due to lot# changed to crsp019b - (dp 01nov23) the production and quality control documentation for lot # crsp019b expiration date (2025-09) was manufactured on 27oct22 packaged 8036 kits were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # crsp019b no capa was required.As of 02nov2023 there are 5 complaints on file for lot# crsp019 and all related sublots.5 complaints are on file for lot# crsp019b: (1) syringe broken while use/adverse event report, (1) leakage and (3) adverse event reports.Sanofi will continue to monitor complaints and trending to determine if capa(corrective and preventive actions) was required.The final investigation was completed on 03-nov-2023 with summarized conclusion as no assessment possible additional information was received on 06-jul-2023 by quality department: ptc number added.Strength was added, upon retrospective view case was updated to serious, corresponding field updated; text amended additional information was received on 01-aug-2023 from healthcare professional (quality department).Ptc results were added.Text amended accordingly.Additional information was received on 14-aug-2023 from patient: new event (injection site joint erythema) added.Verbatim of event injection site joint pain and gait disturbance updated.Text was amended accordingly.Additional information was received on 23-aug-2023 from patient: seriousness criteria of event pain in extremity, injection site joint swelling , injection site joint pain updated; event of injection site joint effusion, joint stiffness, meniscus injury , muscle strain added; as reported term and seriousness of event injection site joint erythema updated; as reported of event injection site joint swelling, gait disturbance updated; lab added; medical history updated; treatment added for event injection site joint pain, injection site joint swelling; concomitant added; therapy details updated; onset of all events updated; indication updated; text was amended accordingly.Additional information was received on 07-sep-2023 from patient.Batch number was added.Clinical course was updated.Text amended accordingly.Additional information was received on 01-nov-2023 by quality department from other health care professional: the complaint 100342242 has been reopened for the following reason: incomplete complaint information, no new significant information received; text amended additional information was received on 03-nov-2023 by quality department from other health care professional: ptc details added; expiry date updated; text amended.Additional information was received on 06-nov-2023 from patient.The event verbatim of gait disturbance and injection site joint swelling was updated.Text amended accordingly.Additional information was received on 10-nov-2023 from physician: as reported term of event injection site joint pain, joint stiffness updated; new event of device ineffective added; outcome of event joint stiffness updated from unknown to not recovered; previous orthovisc injection date added; expiry date updated from 30-sep-2025 to 20-sep-2025; new treatment drug cortisone injection added; treatment drug naperotion added; indication updated; medical history updated; event of aspiration joint added; text amended accordingly.Additional information was received on 14-nov-2023 from physician: expiry date was updated; upon internal review, the information received with csd (clock start date) 10-nov-2023 was assessed significant for device;text amended accordingly.

Event Description

Mobility is still very limited [mobility decreased].Strain of left calf muscle [muscle strain].Pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain/piercing pain from my left knee down my calf to my ankle [unilateral leg pain] ([condition aggravated]).Complex tear involving the body and posterior horn of the medial meniscus with peripheral [meniscus injury].When she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking/unable to walk/hard to walk/ every five minutes she has to sit down [difficulty in walking].Redness/left knee redness [injection site joint redness].Swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling/left knee swelling/ brought back the swelling [injection site joint swelling] ([condition aggravated]).Stiff leg (unable to bend left knee)/stiffness" following the 3rd & last dose of synvisc [joint stiffness] ([joint range of motion decreased]).Experiencing pain from the back of her knee (left knee)/began to experience increased pain/there was just a little pain/experience severe pain/suffering with terrible pain [injection site joint pain] ([condition aggravated]).Fluid in knee [injection site joint effusion].Removed fluid from the knee/left knee aspiration [aspiration of joint].Back hurts/began to experience increased pain [back pain aggravated].Synvisc treatment was ineffective for her condition with no reported adverse event [device ineffective].Case narrative: initial information was received from united states on 06-jul-2023 regarding an unsolicited valid serious case from a patient.The case is linked with (b)(4) (same patient; non company drug- orthovisc treatment), (b)(4) (same patient; non company drug- cortisone treatment), (b)(4) (cluster).This case involves 77 years old female patient whose mobility is still very limited, strain of left calf muscle, pain in her leg/gets pain all the way down to her ankle/experiencing pain from the back of her knee, all the way down her calf/began to experience increased pain/piercing pain from my left knee down my calf to my ankle, complex tear involving the body and posterior horn of the medial meniscus with peripheral, when she first gets up in the morning, the pain is not bad, but within 5 to 7 minutes, she is having difficulty walking/unable to walk/hard to walk/ every five minutes she has to sit down, redness/left knee redness, swelling is mostly in the back of her knee/swelling has decreased some/began to experience increased pain and swelling/left knee swelling/ brought back the swelling, stiff leg (unable to bend left knee)/stiffness" following the 3rd & last dose of synvisc, experiencing pain from the back of her knee (left knee)/began to experience increased pain/there was just a little pain/experience severe pain/suffering with terrible pain, fluid in knee, removed fluid from the knee/left knee aspiration, back hurts/began to experience increased pain and synvisc treatment was ineffective for her condition with no reported adverse event while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, vaccination(s), concomitant medications was not provided.At the time of the event, the patient had ongoing acute pain of left knee, primary osteoarthritis of left knee, and minimal housework seated many time day, pain from knee to ankle when walking after 5 mins; left calf pain.Patient received orthovisc (autovisc) treatments to her right knee 2 or 3 different times (few years ago) with no problem /no adverse reaction with orthovisc 3 injections.Helped lubricate right knee till present time.Patient had no previous history of adverse reaction when treated with similar hyaluronic injection, orthovisc in (b)(6) 2021; patient never had a problem, just a little pain so decided to lubricate left knee.Patient had sterile viscoelastic solution synvisc injected aseptically with ultrasound guidence in a multidose (series of 3 total injections) storage as recommended by manufacturer.This time, when doing the left knee, she chose synvisc because it was dollar 8 cheaper, and she thought it would be the same.She received the first 2 injections 1 week apart (on (b)(6) 2023 at a dose of 8mg).The third injection she received 2 weeks after the second because she was out of town.On (b)(6) 2023, the patient received 3rd injection of the series of hylan g-f 20, sodium hyaluronate of strength 16 mg/2 ml in the left knee via ultrasound technique at a dose of 8 mg 1x (once) (batch number: crsp019b, expiry date: 30-sep-2025, route - unknown) for primary osteoarthritis of left knee/left knee advanced osteoarthritis, severe.The patient's left knee joint was prepped using aseptic technique with alcohol and chlorhexadine.The patient was placed in a supine position with knee flexed to 20 degrees.Superficial anesthesia was achieved with ethyl chloride spray.The third dose of synvisc 1 mg was injected using a 22 gauge needle via supralateral approach.The entire procedure was performed using normal aseptic technique.Synvisc was injected into the joint without difficulty.The patient reports that she received 3 synvisc shots which were administered by her doctor.After the third dose, on (b)(6) 2023 (latency: same day) she began to experience increased pain and swelling (injection site joint swelling, injection site joint pain, condition aggravated).The patient stated there was just a little pain but she didn't expect the redness (injection site joint erythema), swelling, unable to walk and having to put the hot bath on her for a few minutes.Patient had left knee pain, swelling redness, fluid in knee (hard to walk) (injection site joint effusion), stiff leg (unable to bend left knee) (joint stiffness, joint range of motion decreased) (onset: (b)(6) 2023, latency: same day).She stated that when she first gets up in the morning, the pain was not bad, but within 5 to 7 minutes, she was having difficulty walking (gait disturbance, onset: (b)(6) 2023, latency: same day).On an unknown date in (b)(6) 2023, (approximately 1 week latency) patient reports that a week later latency: few days she developed pain in her leg, her knee became swollen, and her back hurts (back pain).She reports that she gets pain all the way down to her ankle.She states that her mobility was still very limited (mobility decreased), although the swelling has decreased some.Her doctor did an ultrasound after 2 weeks to rule out a blood clot.At that time, he wanted to give her an ia (intra-articular) cortisone injection, but she declined because she was afraid to get another injection.At this point, she was experiencing pain from the back of her knee, all the way down her calf (pain in extremity) (condition aggravated, onset: (b)(6) 2023, latency: same day).The swelling was mostly in the back of her knee.She requires rest and elevation of the limb after just a few minutes of walking around her house.She was currently sitting on her couch, with her left leg elevated and a cortisone 5% patch on the back of her knee and a hot pad on the front.She was taking ibuprofen 800mg routinely.She was using hot pads every day and uses ibuprofen; states she was still in pain; it was difficult for her to walk.The patient would like to discuss synvisc adverse reactions; asks what should she do? mis (abbreviation not available) attempted to transfer to synvisc-trained mis.Mis discussed pharmacokinetics (consumer asks how long synvisc stays in her system) and pseudosepsis srds (standard reference documents).Referred to hcp (healthcare professional).On an unknown date in 2023 (latency: few days) mri (magnetic resonance imaging) left knee without contrast was performed with result as complex tear involving the body and posterior horn of the medial meniscus with peripheral (meniscus injury) and also strain of left calf muscle(muscle strain) (onset: 2023; unknown latency).On (b)(6) 2023; latency: 3 months 20 days, physician, removed liquid from left knee with ultra sound (aspiration joint; intervention required).Doctor scheduled a cortisone shot on (b)(6) 2023.The patient could not handle pain and symptom.On (b)(6) 2023, patient got cortisone injection in left knee.She also said that so many people have suffered from the synvisc shot that is a bad reaction of swelling, burning, paining, and the whole leg from the back of her knee all the way down to her calf to her ankle.She's really suffering and always sitting on a hot bath.Patient also stated that the two aspirations performed on her weren't helpful and she was given a cortisone shot and but it was removed because it brought back the swelling and the pain.Patient stated it's been five months and she's suffering terribly from the synvisc shot.Patient reported she continued to experience severe pain , stiffness following the 3rd & last dose of synvisc, indiactive that the synvisc treatment was ineffective for her condition(device ineffective; onset: 2023; latency: few months).Prp injection (platelet -rich plasma) therapy may be beneficial.Patient said she's suffering so much that every five minutes she has to sit down after putting the heating pad on her knee that's why she called and wanted to know how people got cured.Patient was still suffering with terrible pain (also the cortisone shots swelled up the knee) since end of may until nov., and will go next week to pain management.Patient was very angry and upset by the result from product and present suffering, unable to walk without piercing pain from her left knee down her calf to ankle.Her knee pain was minimal before these three shots.Relevant laboratory test results included: magnetic resonance imaging joint - in 2023: with following result.Medial compartment showed a complex tear is detected in the body and posterior horn of the medial meniscus.The tear has both longitudinal horizontal and vertical components and is associated with peripheral meniscal extrusion.The medial collateral ligament is intact but peripherally bowed by the extruded medial meniscus as well as medial osteophytes.There is high-grade cartilage loss along the weightbearing surfaces of the medial compartment with trace subchondral edema.Lateral compartment showed the lateral meniscus is intact.No displaced meniscal fragments are identified.Examination of the posterolateral corner demonstrates intact biceps femoris tendon, fibular collateral ligament, and popliteus tendon.No focal osteochondral injury is identified.Patellofemoral compartment showed the extensor mechanism is intact.Mild to moderate chondral thinning is observed without significant subchondral edema.No abnormal patellar tilt or subluxation is noted.The medial and lateral retinaculum are intact.Cruciate ligaments showed the anterior and posterior cruciate ligaments are intact with other finding as a moderate joint effusion was identified.There is trace fluid in the expected location of a baker's cyst.Impression illustrated complex tear involving the body and posterior horn of the medial meniscus with peripheral].Ultrasound scan - in (b)(6) 2023: [ultrasound was done to rule out a blood clot: unknown results].Action taken: not applicable for all events.Corrective treatment: ibuprofen and used hot pads every day for pain in extremity, injection site joint pain, back pain, injection site joint swelling, injection site joint erythema, cortisone patches and cortisone injection, naperotion(unspecified drug) for injection site joint swelling, injection site joint pain, gait disturbance, pain in extremity, mobility decreased; advil and methylprednisolone for injection site joint effusion, injection site joint erythema, injection site joint pain, injection site joint swelling, pain in extremity, gait disturbance, joint stiffness, muscle strain; rest and elevation of limb for gait disturbance and mobility decreased; icing for injection site joint swelling and injection site joint pain; pad for injection site joint effusion and gait disturbance and not reported for rest events.Outcome: not recovered for mobility decreased, injection site joint pain , joint stiffness , injection site joint erythema , muscle strain, pain in extremity, gait disturbance; unknown for meniscus injury, injection site joint effusion ; recovering for injection site joint swelling, seriousness criteria: intervention required for aspiration joint, mobility decreased; intervention required and disability for joint stiffness , injection site joint swelling , injection site joint pain , injection site joint erythema , muscle strain, injection site joint effusion , pain in extremity, gait disturbance; disability for meniscus injury.A product technical complaint (ptc) was initiated on 06-jul-2023 for synvisc.Batch number; crsp019b, expiry date: 30-sep-2025; global ptc number: 100342242.Sample status of ptc was not available, and ptc stated preliminary assessment: complaint: adverse event preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.Investigation (tj 24jul2023) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) was required.Reopened investigation due to lot# changed to crsp019b - (dp 01nov23) the production and quality control documentation for lot # crsp019b expiration date (2025-09) was manufactured on 27oct22 packaged 8036 kits were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # crsp019b no capa was required.As of 02nov2023 there are 5 complaints on file for lot# crsp019 and all related sublots.5 complaints are on file for lot# crsp019b: (1) syringe broken while use/adverse event report, (1) leakage and (3) adverse event reports.Sanofi will continue to monitor complaints and trending to determine if capa(corrective and preventive actions) was required.The final investigation was completed on 03-nov-2023 with summarized conclusion as no assessment possible.Additional information was received on 06-jul-2023 by quality department: ptc number added.Strength was added, upon retrospective view case was updated to serious, corresponding field updated; text amended.Additional information was received on 01-aug-2023 from healthcare professional (quality department).Ptc results were added.Text amended accordingly.Additional information was received on 14-aug-2023 from patient: new event (injection site joint erythema) added.Verbatim of event injection site joint pain and gait disturbance updated.Text was amended accordingly.Additional information was received on 23-aug-2023 from patient: seriousness criteria of event pain in extremity, injection site joint swelling , injection site joint pain updated; event of injection site joint effusion, joint stiffness, meniscus injury , muscle strain added; as reported term and seriousness of event injection site joint erythema updated; as reported of event injection site joint swelling, gait disturbance updated; lab added; medical history updated; treatment added for event injection site joint pain, injection site joint swelling; concomitant added; therapy details updated; onset of all events updated; indication updated; text was amended accordingly.Additional information was received on 07-sep-2023 from patient.Batch number was added.Clinical course was updated.Text amended accordingly.Additional information was received on 01-nov-2023 by quality department from other health care professional: the complaint (b)(4) has been reopened for the following reason: incomplete complaint information, no new significant information received; text amended.Additional information was received on 03-nov-2023 by quality department from other health care professional: ptc details added; expiry date updated; text amended.Additional information was received on 06-nov-2023 from patient.The event verbatim of gait disturbance and injection site joint swelling was updated.Text amended accordingly.Additional information was received on 10-nov-2023 from physician: as reported term of event injection site joint pain, joint stiffness updated; new event of device ineffective added; outcome of event joint stiffness updated from unknown to not recovered; previous orthovisc injection date added; expiry date updated from 30-sep-2025 to 20-sep-2025; new treatment drug cortisone injection added; treatment drug naperotion added; indication updated; medical history updated; event of aspiration joint added; text amended accordingly.Additional information was received on 14-nov-2023 from physician: expiry date was updated; upon internal review, the information received with csd (clock start date) 10-nov-2023 was assessed significant for device;text amended accordingly.Additional information was received on 20-nov-2023 from patient: no new significant information was received; clinical course updated; text amended.Additional information was received on 20-nov-2023 from patient: as reported term of event pain in extremity, injection site joint pain updated; text amended.

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Brand Name

SYNVISC

Type of Device

MOZ

Manufacturer (Section D)

GENZYME CORPORATION(RIDGEFIELD)

1125 pleasantview terrace

ridgefield 07657

Manufacturer (Section G)

GENZYME CORPORATION(RIDGEFIELD)

1125 pleasantview terrace

ridgefield 07657

Manufacturer Contact

heather schiappacasse

55 corporate drive, ms 55b-220

bridgewater 08807

MDR Report Key

17344015

MDR Text Key

319270677

Report Number

2246315-2023-00080

Device Sequence Number

Product Code

MOZ

Combination Product (y/n)

Reporter Country Code

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Health Professional

Reporter Occupation

Physician

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

07/18/2023

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Lot Number

CRSP019B

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Yes

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Disability; Required Intervention;

Patient Sex

Female

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

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