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

Lot Number UNKNOWN

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

Patient Problems Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Third time was bad, both my knees blew up(right knee) [injection site joint swelling] had to go to the emergency room to have them drained up on both sides (right knee) [arthrocentesis] case narrative: initial information was received on (b)(6) 2023 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case is linked with case id (b)(4) (multiple devices used in same patient).This case involves 64 years old female patient who reported third time was bad, both knees blew up(right knee) and had to go to the emergency room to have them drained up on both sides after being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.The patient had synvisc-one injections in the past.The first two times, all went well, it was also injections to both knees, the effect lasted a year each time, and they were administered a year apart.In 2017, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection for the third time in right knee at a dose of 1 dosage form once via route intra-articular (with an unknown strength, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.First time product used: no the patient reported that the third time was bad, both her knees blew up (injection site joint swelling, onset: 2017, latency: unknown).She had to go to the emergency room to have them drained up on both sides (aspiration joint, onset: 2017, latency: unknown).She has not done these injections in about 6 years, and the orthopedic surgeon suggested her to try again.Action taken: not applicable for both events.Corrective treatment: visit to emergency room to have the knee drained up on both sides for injection site joint swelling.At time of reporting, the outcome was unknown for both events.Reporter causality: not reported for both events.Company causality: not reportable for both events.Seriousness criteria: medically significant for both events.

Event Description

Third time was bad, both my knees blew up(right knee) [injection site joint swelling].Had to go to the emergency room to have them drained up on both sides(right knee) [arthrocentesis].Case narrative: initial information was received from canada on 10-nov-2023 regarding an unsolicited valid serious case from a patient.This case is linked with case id (b)(4), (b)(4) and (b)(4) (multiple devices used in same patient).This case involves 64 years old female patient who reported third time was bad, both knees blew up(right knee) and had to go to the emergency room to have them drained up on both sides after being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient had medical history included had many tears in meniscus.The patient's past medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.The patient had synvisc-one injections in the past.She had received her first injections about ten years ago in both her knees for osteoarthritis and lasted a good year.One knee she had many tears in meniscus.The following year she had the injections again.The first two times, all went well, it was also injections to both knees, the effect lasted a year each time, and they were administered a year apart.In 2017, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection for the third time in right knee at a dose of 1 dosage form once via route intra-articular (strength: 48 mg/6 ml) (with an unknown expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.First time product used: no the patient reported that the third time was bad, both her knees blew up (injection site joint swelling, onset: 2017, latency: unknown).She had to go to the emergency room to have them drained up on both sides (aspiration joint, onset: 2017, latency: unknown).She has not done these injections in about 6 years, and the orthopedic surgeon suggested her to try again.Action taken: not applicable for both events.Corrective treatment: visit to emergency room to have the knee drained up on both sides for injection site joint swelling.At time of reporting, the outcome was unknown for both events.A product technical complaint (ptc) was initiated on 10-nov-2023 for synvisc one (batch number: unknown) with global ptc number: (b)(4).The sample status was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there was 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.(13nov2023) investigation (13nov2023) the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was 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 to determine if a capa (corrective and preventive action) was required.The final investigation for the ptc was completed on 14-nov-2023 with summarized conclusion as 'no assessment possible'.Reporter causality: not reported for both events.Company causality: reportable for both events.Seriousness criteria: medically significant and intervention required for both the events.Additional information was received on 10-nov-2023 from patient.Medical history was added.Text amended accordingly.Additional information was received on 14-nov-2023 from quality department.Suspect strength, global ptc number and ptc results were added.Text amended accordingly.Based on the previously received information, this case previously processed as solicited was updated to unsolicited.

Manufacturer Narrative

Sanofi company comment dated on 20-nov-2023: this case involves 64 years old female patient who reported third time was bad, both knees blew up(right knee) and had to go to the emergency room to have them drained up on both sides after being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].Based on the limited information provided regarding this case, causal role of the company suspect product can not be excluded.However, more information of past and concomitant medication, and any relevant medical history of patient, any concurrent conditions would aid in better case assessment.

Event Description

Third time was bad, both my knees blew up (right knee) [injection site joint swelling].Had to go to the emergency room to have them drained up on both sides(right knee) [arthrocentesis].Case narrative: initial information was received on 10-nov-2023 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case is linked with case id: (b)(4) (multiple devices used in same patient).This case involves 64 years old female patient who reported third time was bad, both knees blew up(right knee) and had to go to the emergency room to have them drained up on both sides after being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.The patient had medical history included had many tears in meniscus.The patient had synvisc-one injections in the past.She had received her first injections about ten years ago in both her knees for osteoarthritis and lasted a good year.One knee she had many tears in meniscus.The following year she had the injections again.The first two times, all went well, it was also injections to both knees, the effect lasted a year each time, and they were administered a year apart.In 2017, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection for the third time in right knee at a dose of 1 dosage form once via route intra-articular (with an unknown strength, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.First time product used: no.The patient reported that the third time was bad, both her knees blew up (injection site joint swelling, onset: 2017, latency: unknown).She had to go to the emergency room to have them drained up on both sides (aspiration joint, onset: 2017, latency: unknown).She has not done these injections in about 6 years, and the orthopedic surgeon suggested her to try again.Action taken: not applicable for both events.Corrective treatment: visit to emergency room to have the knee drained up on both sides for injection site joint swelling.At time of reporting, the outcome was unknown for both events.Reporter causality: not reported for both events.Company causality: reportable for both events.Seriousness criteria: medically significant and intervention required for both events.Additional information was received on 10-nov-2023 from patient.Medical history was added.Text amended accordingly.

Event Description

Third time was bad, both my knees blew up(right knee) [injection site joint swelling] had to go to the emergency room to have them drained up on both sides(right knee) [arthrocentesis].Case narrative: initial information was received on 10-nov-2023 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case is linked with (b)(6) (multiple devices used in same patient).This case involves 64 years old female patient who reported third time was bad, both knees blew up(right knee) and had to go to the emergency room to have them drained up on both sides after being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.The patient had medical history included had many tears in meniscus.The patient had synvisc-one injections in the past.She had received her first injections about ten years ago in both her knees for osteoarthritis and lasted a good year.One knee she had many tears in meniscus.The following year she had the injections again.The first two times, all went well, it was also injections to both knees, the effect lasted a year each time, and they were administered a year apart.In 2017, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection for the third time in right knee at a dose of 1 dosage form once via route intra-articular (strength: 48 mg/6 ml) (with an unknown expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.First time product used: no.The patient reported that the third time was bad, both her knees blew up (injection site joint swelling, onset: 2017, latency: unknown).She had to go to the emergency room to have them drained up on both sides (aspiration joint, onset: 2017, latency: unknown).She has not done these injections in about 6 years, and the orthopedic surgeon suggested her to try again.Action taken: not applicable for both events.Corrective treatment: visit to emergency room to have the knee drained up on both sides for injection site joint swelling.At time of reporting, the outcome was unknown for both events.A product technical complaint (ptc) was initiated on 10-nov-2023 for synvisc one (batch number: unknown) with global ptc number: 100376466.The sample status was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there was 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.(13nov2023) investigation (13nov2023) the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was 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 to determine if a capa (corrective and preventive action) was required.The final investigation for the ptc was completed on 14-nov-2023 with summarized conclusion as 'no assessment possible'.Reporter causality: not reported for both events.Company causality: reportable for both events.Seriousness criteria: medically significant and intervention required for both events.Additional information was received on 10-nov-2023 from patient.Medical history was added.Text amended accordingly.Additional information was received on 14-nov-2023 from quality department.Suspect strength, global ptc number and ptc results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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; a; bridgewater 08807
• MDR Report Key: 18157592
• MDR Text Key: 328353077
• Report Number: 2246315-2023-00106
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female