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 Ambulation Difficulties (2544); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Can't walk/pain was massive,she can't walk hardly on it [unable to walk].Doctor took a bunch of fluid out [arthrocentesis].Screaming [screaming].Received it in her left knee and she reacted to it, the pain was massive/now the pain is so much worse [injection site joint pain] ([condition aggravated]).Received it in her left knee and she reacted to it, her knee was twice the size [injection site joint swelling].Case narrative: initial information received from united states on 18-dec-2023 regarding an unsolicited valid serious case received from a patient.This case involves an unknown age female patient who can't walk/pain was massive, she can't walk hardly on it, doctor took a bunch of fluid out, screaming, received it in her left knee and she reacted to it, the pain was massive/now the pain is so much worse and received it in her left knee and she reacted to it, her knee was twice the size 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), concomitant medication, and family history were not provided.On an unknown date, a couple years ago, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection in her left knee once via route intra-articular (with an unknown strength, dose, expiry date and batch number).Information on batch number and expiry date was requested.The patient reported that she was calling about synvisc-one, she stated that it was the one you get every 6 months, and she stated that a couple years ago she received it in her left knee and she reacted to it.She stated that her knee was twice the size (injection site joint swelling, onset and latency: unknown) and the pain was massive (injection site joint pain, onset and latency: unknown).She stated that she could not walk hardly on it (gait inability, onset and latency: unknown).She stated that she was screaming (onset and latency: unknown) and that her doctor took a bunch of fluid out (aspiration joint, onset and latency: unknown) and initially it did feel better but now the pain was so much worse (condition aggravated, onset and latency: unknown).She stated that she could not walk and that she suffered so much every day.She stated that her doctor wants to give her the same shot and she was calling because she wants to know what we think of that.The caller states that she really needed a knee replacement, but she was afraid of it.She would like to know if this happened because her doctor injected the synvisc-one incorrectly.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for the events.At time of reporting, the outcome was unknown for all events.Seriousness criteria: medically significant for aspiration joint and disability for gait inability.

Manufacturer Narrative

Sanofi company comment dated 22-dec-2023: this case involves an unknown age female patient who can't walk/pain was massive, she can't walk hardly on it, doctor took a bunch of fluid out, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Based on the limited available information, the causal role of the company suspect device could not be denied for the occurrence of adverse events.The case will be re-evaluated post further update on patient's past medical and drug history, family history, concomitant medications and concurrent conditions, the details of which will aid in comprehensive case assessment.

Event Description

Can't walk/pain was massive,she can't walk hardly on it [unable to walk].Doctor took a bunch of fluid out [arthrocentesis].Doctor took a bunch of fluid out [injection site joint effusion].Screaming [screaming].Received it in her left knee and she reacted to it, the pain was massive/now the pain is so much worse [injection site joint pain] ([condition aggravated]).Received it in her left knee and she reacted to it, her knee was twice the size [injection site joint swelling].Case narrative: initial information received from united states on 18-dec-2023 regarding an unsolicited valid serious case received from a patient.This case involves an unknown age female patient who can't walk/pain was massive, she can't walk hardly on it, doctor took a bunch of fluid out, screaming, received it in her left knee and she reacted to it, the pain was massive/now the pain is so much worse and received it in her left knee and she reacted to it, her knee was twice the size 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), concomitant medication, and family history were not provided.In (b)(6) 2021, the patient received synvisc one (hylan g-f 20, sodium hyaluronate, 48mg/6ml) injection in her left knee once via route intra-articular (with an unknown dose, batch number and expiry date).There will be no information available on the batch number of this case because synvisc-one syringe had been discarded.The patient reported that she was calling about synvisc-one, she stated that it was the one she used to get every 6 months.In (b)(6) 2021, two years ago, she received it in her left knee and she reacted to it.She stated that her knee was twice the size (injection site joint swelling, onset date and latency: unknown) and the pain was massive (injection site joint pain, onset date and latency: unknown).She stated that she could not walk hardly on it (gait inability, onset date and latency: unknown).She stated that she was screaming (onset and latency: unknown) and that her doctor took a bunch of fluid out (aspiration joint, injection site joint effusion, onset date and latency: unknown) and initially it did feel better but now the pain was so much worse (condition aggravated, onset date and latency: unknown).She stated that she could not walk and that she suffered so much every day.She stated that her doctor wanted to give her the same shot and she was calling because she wanted to know what we think of that.The caller stated that she really needed a knee replacement, but she was afraid of it.She would like to know if this happened because her doctor injected the synvisc-one incorrectly.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for the events.At time of reporting, the outcome was unknown for all events.Seriousness criteria: intervention required for aspiration joint and injection site joint effusion; disability for gait inability.A product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2023 for synvisc one.Batch number: unknown.Sample status was not available.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.(rc 20dec23) investigation: (rc 04jan24) 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 04-jan-2024 with summarized conclusion as no assessment possible.Additional information was received on 18-dec-2023 from other healthcare professional (from quality department).Gptc number and product strength was added.Also, upon internal review- event was added-injection site joint effusion.Text amended accordingly.Additional information was received on 04-jan-2024 from other healthcare professional (from quality department).Ptc results was added.Text amended accordingly.

Event Description

Can't walk/pain was massive,she can't walk hardly on it [unable to walk].Doctor took a bunch of fluid out [arthrocentesis].Doctor took a bunch of fluid out [injection site joint effusion].Screaming [screaming].Received it in her left knee and she reacted to it, the pain was massive/now the pain is so much worse [injection site joint pain] ([condition aggravated]).Received it in her left knee and she reacted to it, her knee was twice the size [injection site joint swelling].Case narrative: initial information received from united states on 18-dec-2023 regarding an unsolicited valid serious case received from a patient.This case involves an unknown age female patient who can't walk/pain was massive, she can't walk hardly on it, doctor took a bunch of fluid out, screaming, received it in her left knee and she reacted to it, the pain was massive/now the pain is so much worse and received it in her left knee and she reacted to it, her knee was twice the size 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), concomitant medication, and family history were not provided.In 2021, the patient received synvisc one (hylan g-f 20, sodium hyaluronate, 48mg/6ml) injection in her left knee once via route intra-articular (with an unknown dose, batch number and expiry date).There will be no information available on the batch number of this case because synvisc-one syringe had been discarded.The patient reported that she was calling about synvisc-one, she stated that it was the one she used to get every 6 months.In 2021, two years ago, she received it in her left knee and she reacted to it.She stated that her knee was twice the size (injection site joint swelling, onset date and latency: unknown) and the pain was massive (injection site joint pain, onset date and latency: unknown).She stated that she could not walk hardly on it (gait inability, onset date and latency: unknown).She stated that she was screaming (onset and latency: unknown) and that her doctor took a bunch of fluid out (aspiration joint, injection site joint effusion, onset date and latency: unknown) and initially it did feel better but now the pain was so much worse (condition aggravated, onset date and latency: unknown).She stated that she could not walk and that she suffered so much every day.She stated that her doctor wanted to give her the same shot and she was calling because she wanted to know what we think of that.The caller stated that she really needed a knee replacement, but she was afraid of it.She would like to know if this happened because her doctor injected the synvisc-one incorrectly.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for the events.At time of reporting, the outcome was unknown for all events.Seriousness criteria: intervention required for aspiration joint and injection site joint effusion; disability for gait inability.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 18-dec-2023 for synvisc one.Batch number: unknown sample status was not available.Ptc was set in process and results for same were awaited.Additional information was received on 18-dec-2023 from other healthcare professional (from quality department).Gptc number and product strength was added.Also, upon internal review- event was added-injection site joint effusion.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: 18383105
• MDR Text Key: 331295433
• Report Number: 2246315-2023-00116
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/26/2023; 01/08/2024
• 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): Other; Disability; Required Intervention
• Patient Sex: Female