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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ
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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ Back to Search Results
Lot Number 9RSL001ZE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); Arthralgia (2355); Ambulation Difficulties (2544); Swelling/ Edema (4577); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/01/2020
Event Type  Injury  
Event Description
Was not able to walk, her knees became swollen, knees drained arthrocentesis.Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon i synvisc one".Patient id: (b)(6); country: (b)(6), study title: patient support program involving synvisc one.This case involves a (b)(6)female patient who was not able to walk, her knees became swollen and her knees drained with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dosage of 6 ml for once only via unknown route (lot - 9rsl001ze) for osteoarthritis in left knee.On the dec-2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Action taken: not applicable for all the events.Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events.Outcome: recovered for all the events.Reporter causality: related for all the events.Company causality: reportable for all the events.
 
Event Description
Was not able to walk, her knees became swollen, knees drained arthrocentesis.Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon i synvisc one".Patient id: (b)(6); country: (b)(6), study title: patient support program involving synvisc one.This case involves a (b)(6)female patient who was not able to walk, her knees became swollen and her knees drained with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dosage of 6 ml for once only via unknown route (lot - 9rsl001ze) for osteoarthritis in left knee.On the (b)(6) 2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Action taken: not applicable for all the events.Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events.Outcome: recovered for all the events.Reporter causality: related for all the events.Company causality: reportable for all the events.
 
Event Description
Was not able to walk [unable to walk.] her knees became swollen [swelling of l knee.] knees drained [arthrocentesis.] case narrative: initial information received on 16-nov-2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: (b)(6); country: canada.Study title: patient support program involving synvisc one.This case involves a 58-year-old female patient who was not able to walk, her knees became swollen and her knees drained with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6 ml) at the dosage of 6 ml for once only via unknown route (lot - 9rsl001ze; expiry date: nov-2021) for osteoarthritis in left knee.On the dec-2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Action taken: not applicable for all the events.Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events.Outcome: recovered for all the events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 17-nov-2021 for product.Batch number: 9rsl001ze.Sample status: not available.Device not returned.The production and quality control documentation for lot 9rsl001ze expiration date nov-2021 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl001ze no capa (corrective and preventive action) is required.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 has not indicated any safety issue.As of 01dec21 there are6 complaints on file for lot# 9rsl001z and all related sublots.1 complaint is on file for lot# 9rsl001z: (1) adverse event report.5 complaints are on file for lot# 9rsl001ze: (5) adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa (corrective and preventive action) was required.Final investigation complete date: 01-dec-2021 with summary code as no assessment possible.Reporter causality: related for all the events.Company causality: reportable for all the events.Additional information was received on 01-dec-2021 from healthcare professional.Global ptc results, form and strength added.Text was amended accordingly.
 
Event Description
Was not able to walk/joint range of motion decreased [unable to walk] her knees became swollen [swelling of l knee] knees drained [arthrocentesis] unable to walk or bend her knees [joint range of motion decreased] was hard time getting out of bed [difficulty in standing] lot of pain; excruciating pain; pain in her left knee [injection site joint pain] she might be allergic to it or maybe it was too much in one time.[allergic reaction nos] did not really work for her with no reported adverse event [device ineffective] case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: (b)(6); country: canada study title: patient support program involving synvisc one.This case involves a 58 years old female patient who said was not able to walk/joint range of motion decreased, her knees became swollen, knees drained, lot of pain; excruciating pain; pain in her left knee, she might be allergic to it or maybe it was too much in one time.Unable to walk or bend her knees and did not really work for her with no reported adverse event, was hard time getting out of bed while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), and family history were not provided.Patient did say she had some pain in her left knee before the injection.Concomitant medications included curcuma longa (turmeric [curcuma longa]); vitamin d nos (vitamin d [vitamin d nos]); and calcium citrate, magnesium citrate (calcium magnesium [calcium citrate;magnesium citrate]).On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6 ml) at the dosage of 6 ml for once only via unknown route (lot - 9rsl001ze; expiry date: (b)(6) 2021) for osteoarthritis in left knee.In (b)(6) 2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Patient returned a sanofi reminder call and mentioned that she had a synvisc- one injection in both knees for severe osteoarthritis.Patient thought it did not really work for her (device ineffective) (onset: (b)(6) 2020; latency: approx.Few weeks).She said that her knees felt weird/strange and that about a week to a week and a half later she had a reaction to the injections.Patient thought she might be allergic to it or maybe it was too much in one time (hypersensitivity) (onset: (b)(6) 2020; latency: approx.Few weeks).She woke up and her knees became very swollen, the swelling started a week later and it kept swelling.She could hardly walk and had excruciating pain (injection site joint pain) (onset: (b)(6) 2020; latency: approx.Few weeks).She said she felt that her knees would explode due to the swelling.She had a hard time getting out of bed (dysstasia) (onset: (b)(6) 2020; latency: approx.Few weeks), was unable to walk or bend her knees (joint range of motion decreased)(onset: (b)(6) 2020; latency: approx.Few weeks).She felt in worse shape after having the injections.She returned to the physician in a wheelchair so that her knees could be drained.There was a lot of fluid removed and then she received cortisone shots in each knee, which helped with the pain.The swelling went down within a few days and she was able to walk and bend her knees.All this took place during covid.Patient after three years, because of covid was able to get a physical with her physician.She mentioned she walks on her lunch breaks, however damp weather was really bad for her.She takes turmeric pills, vitamin d (for five years now), calcium with magnesium, and glycerin cryoterine.The patient also mentioned it was the only time she received injections.Since march she was experiencing a lot of pain and was in the process of changing ortho surgeons.She would like a second opinion.The injection we have in our system was a synvisc-one injection in each knee on tuesday, (b)(6) 2020 for osteoarthritis.Action taken : was not applicable for all events.The patient was treated with cortisone (cortisone) for injection site joint pain and not reported for other events.At time of reporting, the outcome was recovered / resolved on an unknown date for the event her knees became swollen, was recovered / resolved on an unknown date for the event was not able to walk, was recovered / resolved on an unknown date for the event knees drained, was recovered / resolved on an unknown date for the event lot of pain; excruciating pain; pain in her left knee, was unknown for the event did not really work for her and was unknown for the event she might be allergic to it or maybe it was too much in one time; recovered for the event unable to walk or bend her knees and was hard time getting out of bed.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product.Batch number: (b)(4) sample status: not available device not returned.The production and quality control documentation for lot 9rsl001ze expiration date (b)(6) 2021 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl001ze no capa (corrective and preventive action) is required.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 has not indicated any safety issue.As of 01dec21 there are 6 complaints on file for lot# 9rsl001z and all related sublots.1 complaint is on file for lot# 9rsl001z: (1) adverse event report.5 complaints are on file for lot# 9rsl001ze: (5) adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa (corrective and preventive action) was required.Final investigation complete date: (b)(6) 2021 with summary code as no assessment possible.Reporter causality: not reported for events device ineffective, joint range of motion decreased , hypersensitivity, dysstasia, injection site joint pain and related for all the other events.Company causality: not reportable for events device ineffective, joint range of motion decreased , hypersensitivity, dysstasia, injection site joint pain and reportable for all the other events.The production and quality control documentation for lot 9rsl001ze expiration date (b)(6) 2021 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl001ze no capa (corrective and preventive action) is required.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 has not indicated any safety issue.As of (b)(6) 21 there are6 complaints on file for lot# 9rsl001z and all related sublots.1 complaint is on file for lot# 9rsl001z: (1) adverse event report.5 complaints are on file for lot# 9rsl001ze: (5) adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa (corrective and preventive action) was required.Final investigation complete date: (b)(6) 2021 with summary code as no assessment possible.Seriousness criteria: disable for event gait disturbance, dysstasia, joint range of motion decreased and intervention required for the events injection site joint pain, joint range of motion decreased, aspiration joint, joint swelling, gait disturbance, dysstasia additional information was received on (b)(6) 2021 from healthcare professional.Global ptc results, form and strength added.Text was amended accordingly.Additional information was received on (b)(6) 2023 via consumer.History added; event device ineffective, joint range of motion decreased , hypersensitivity, dysstasia, injection site joint pain added; concomitants added; seriousness of the event gait disturbance updated; text amended.
 
Event Description
Was not able to walk/joint range of motion decreased [unable to walk] her knees became swollen [swelling of r knee] knees drained [arthrocentesis] unable to walk or bend her knees [joint range of motion decreased] was hard time getting out of bed [difficulty in standing] lot of pain; excruciating pain [injection site joint pain] she might be allergic to it or maybe it was too much in one time.[allergic reaction nos] did not really work for her with no reported adverse event [device ineffective] case narrative: initial information was received on 16-nov-2021 regarding a solicited valid serious case from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: (b)(6) ; country: canada.Study title: patient support program involving synvisc one.This case is linked to case id (b)(4) (multiple devices used in a single patient, case for left knee).This case involves a 58 years old female patient who was not able to walk/joint range of motion decreased, her knees became swollen, knees drained, lot of pain; excruciating pain, she might be allergic to it or maybe it was too much in one time, unable to walk or bend her knees and did not really work for her with no reported adverse event, was hard time getting out of bed while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), and family history were not provided.Patient did say she had some pain in her left knee before the injection.Concomitant medications included curcuma longa (turmeric); vitamin d nos (vitamin d); and calcium citrate, magnesium citrate (calcium magnesium) and glycerin cryoterine.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48mg/6ml) at the dose of 6 ml once via route intra-articular in his right knee (lot/batch number: 9rsl001ze; expiry date: nov-2021) for severe osteoarthritis in right knee.In (b)(6) 2020, after the latency of two weeks of receiving hylan g-f 20, sodium hyaluronate, patient's knee became swollen (joint swelling) and was not able to walk (gait inability).Her knee was drained (aspiration joint).Patient returned a sanofi reminder call and mentioned that she had a synvisc- one injection in both knees for severe osteoarthritis.Patient thought it did not really work for her (device ineffective) (onset: (b)(6) 2020; latency: approx.Few weeks).She said that her knees felt weird/strange and that about a week to a week and a half later she had a reaction to the injections.Patient thought she might be allergic to it or maybe it was too much in one time (hypersensitivity) (onset: (b)(6) 2020; latency: approx.Few weeks).She woke up and her knees became very swollen, the swelling started a week later and it kept swelling.She could hardly walk and had excruciating pain (injection site joint pain) (onset: (b)(6) 2020; latency: approx.Few weeks).She said she felt that her knees would explode due to the swelling.She had a hard time getting out of bed (dysstasia) (onset: (b)(6) 2020; latency: approx.Few weeks), was unable to walk or bend her knees (joint range of motion decreased) (onset: (b)(6) 2020; latency: approx.Few weeks).She felt in worse shape after having the injections.She returned to the physician in a wheelchair so that her knees could be drained.There was a lot of fluid removed and then she received cortisone shots in each knee, which helped with the pain.The swelling went down within a few days and she was able to walk and bend her knees.All this took place during covid.Patient after three years, because of covid was able to get a physical with her physician.She mentioned she walks on her lunch breaks, however damp weather was really bad for her.She takes turmeric pills, vitamin d (for five years now), calcium with magnesium, and glycerin cryoterine.The patient also mentioned it was the only time she received injections.Since march she was experiencing a lot of pain and was in the process of changing ortho surgeons.She would like a second opinion.Action taken: not applicable for all events.Corrective treatment: fluid removal from knee/ knee drained and cortisone shot for injection site joint pain, joint swelling, gait instability, and not reported for other events.At time of reporting, the outcome was recovered in 2020 for joint swelling, gait instability, aspiration joint, joint range of motion decreased, dysstasia, injection site joint pain.Unknown for hypersensitivity and device ineffective.Seriousness criteria: disability for event gait disturbance, dysstasia, joint range of motion decreased and intervention required for the events injection site joint pain, joint range of motion decreased, aspiration joint, joint swelling, gait disturbance, dysstasia reporter causality: not reported for events device ineffective, joint range of motion decreased, hypersensitivity, dysstasia, injection site joint pain and related for all the other events.Company causality: not reportable for events device ineffective, joint range of motion decreased, hypersensitivity, dysstasia, injection site joint pain and reportable for all the other events.Product technical complaint (ptc) was initiated with global ptc number 100175904 on 17-nov-2021 for product.Batch number: 9rsl001ze.Sample status: not available.Device not returned.The production and quality control documentation for lot 9rsl001ze expiration date nov-2021 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl001ze no capa (corrective and preventive action) is required.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 has not indicated any safety issue.As of 01dec21 there are 6 complaints on file for lot# 9rsl001z and all related sublots.1 complaint is on file for lot# 9rsl001z: (1) adverse event report.5 complaints are on file for lot# 9rsl001ze: (5) adverse event reports.Sanofi would continue to monitor complaints to determine if a capa (corrective and preventive action) was required.Final investigation complete date: 01-dec-2021 with summary code as no assessment possible.A product technical complaint (ptc) was initiated on 17-may-2023 (ptc start date) for synvisc-one (lot/batch number: 9rsl001ze) with global ptc number: 100328267.The sample status of the ptc was not available and the ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a 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 - (dp 17may23).Investigation (24may2023) batch # 9rsl001ze, synvisc one was manufactured on 08dec2018 with expiration date of 30nov2021 yielding (b)() singles.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.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.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Customer sample was not available.Root cause could not be determined.Trend analysis: there are a total of 13 complaints for mother lot 9rsl001z and sub-batches.60707 9rsl001zb temperature excursion 61254 9rsl001zb temperature excursion 61787 9rsl001zc expiration dating 100081518 9rsl001ze adverse event100089476 9rsl001ze adverse event100107416 9rsl001z adverse event100110334 9rsl001ze without/not enough effect100175904 9rsl001ze adverse event100175906 9rsl001ze adverse event100218818 9rsl001ze adverse event100226246 9rsl001ze without/not enough effect100328264 9rsl001ze adverse event/without-not enough effect100328267 9rsl001ze adverse event/without-not enough effect.There is no quality related defect that would attribute to a 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.This review has not indicated any safety issue.Based on investigation and trend analysis, no capa required.Sanofi will continue to adverse events.Trend analysis will be performed on a periodic basis to determine if a capa is required.The final investigation was completed on 02-jun-2023 (closed ptc date) with summarized conclusion as no assessment possible.Additional information was received on 01-dec-2021 from healthcare professional.Global ptc results, form and strength added.Text was amended accordingly.Additional information was received on 16-may-2023 via consumer.History added; event device ineffective, joint range of motion decreased , hypersensitivity, dysstasia, injection site joint pain added; concomitants added; seriousness of the event gait disturbance updated; text amended.Additional information was received on 02-jun-2023 from quality department via a healthcare professional: new ptc number with all details and results was added.Text was amended.
 
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Brand Name
SYNVISC ONE
Type of Device
MOZ
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key12876021
MDR Text Key285177601
Report Number2246315-2021-00175
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 06/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date11/01/2021
Device Lot Number9RSL001ZE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CALCIUM MAGNESIUM [CALCIUM CITRATE,MAGNESIUM CITRA.; CALCIUM MAGNESIUM [CALCIUM CITRATE,MAGNESIUM CITRA.; TURMERIC [CURCUMA LONGA] (CURCUMA LONGA),UNKNOWN.; TURMERIC [CURCUMA LONGA] (CURCUMA LONGA),UNKNOWN.; VITAMIN D [VITAMIN D NOS] (VITAMIN D NOS),UNKNOWN.; VITAMIN D [VITAMIN D NOS] (VITAMIN D NOS),UNKNOWN.
Patient Outcome(s) Disability; Required Intervention;
Patient SexFemale
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