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

Lot Number BRSL010B

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

Patient Problems Necrosis (1971); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2021

Event Type  Injury  

Event Description

Skin necrosis, (skin pain, burning sensation).Hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg hematoma.Case narrative: initial information from (b)(6) received on (b)(6) 2021 regarding an unsolicited valid serious case received from a pharmacist.This case involves an unknown age male patient who had skin necrosis, hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg, pain and burning on the left knee 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) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection once (lot brsl010b) (dose, route, expiry date: unknown).On an unknown date in (b)(6) 2021 a hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg appeared (hematoma; latency: unknown).On (b)(6) 2021 the patient returned in emergency and was found to have a large area of skin necrosis (onset: (b)(6) 2021; latency: unknown; seriousness: medically significant) with pain (pain of skin; onset: (b)(6) 2021; latency: unknown; seriousness: medically significant) and burning on the left knee (burning sensation; onset: (b)(6) 2021; latency: unknown; seriousness: medically significant).No intra-articular effusion was observed.A dermatological opinion was required with the implementation of a local treatment as well as a biological control.Action taken: not applicable for both events it was not reported if the patient received a corrective treatment for both the events.At time of reporting, the outcome was unknown for both events.

Event Description

Skin necrosis [skin necrosis] ([skin pain], [burning sensation]).Hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg [hematoma].Case narrative: initial information from france received on 22-dec-2021 regarding an unsolicited valid serious case received from a pharmacist.This case involves an unknown age male patient who had skin necrosis, hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg, pain and burning on the left knee 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) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection once (lot: brsl010b) (dose, route, expiry date: unknown).On an unknown date on (b)(6) 2021, a hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg appeared (hematoma; latency: unknown).On (b)(6)2021, the patient returned in emergency and was found to have a large area of skin necrosis (onset: on (b)(6) 2021; latency: unknown; seriousness: medically significant) with pain (pain of skin; onset: on (b)(6) 2021; latency: unknown; seriousness: medically significant) and burning on the left knee (burning sensation; onset: on (b)(6) 2021; latency: unknown; seriousness: medically significant).No intra-articular effusion was observed.A dermatological opinion was required with the implementation of a local treatment as well as a biological control.Action taken: not applicable for both events.It was not reported if the patient received a corrective treatment for both the events.At time of reporting, the outcome was unknown for both events.

Event Description

Skin necrosis [skin necrosis] ([skin pain], [burning sensation]).Consequences on daily life: yes, work disruption for 3 weeks [activities of daily living impaired].Hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg [hematoma].Injection of synvisc one was not effective [device ineffective].Case narrative: initial information from france received on 22-dec-2021 regarding an unsolicited valid serious case received from a pharmacist.This case involves an unknown age male patient who had skin necrosis, hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg, pain and burning on the left knee, consequences on daily life: yes, work disruption for 3 weeks and injection of synvisc one was not effective with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included right epicondyle tendinopathy ligamentoplasty of left knee with meniscectomy intrameniscal cyst of anterior horn and residual hernia orthosis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection once (lot - brsl010b) (dose, route, expiry date: unknown).On an unknown date in (b)(6) 2021 a hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg appeared (hematoma; latency: unknown).On (b)(6) 2021 the patient returned in emergency and was found to have a large area of skin necrosis (onset: (b)(6) 2021; latency: unknown; seriousness: medically significant) with pain (pain of skin; onset: (b)(6) 2021; latency: unknown; seriousness: medically significant) and burning on the left knee (burning sensation; onset: (b)(6) 2021; latency: unknown; seriousness: medically significant).This had a consequence on daily life, patient had work disruption for 3 weeks (loss of personal independence in daily activities; seriousness: disability; onset: (b)(6) 2021 and latency: unknown).No intra-articular effusion was observed.A dermatological opinion was required with the implementation of a local treatment as well as a biological control.Slowly positive progress was observed at the consultation on (b)(6) 2021.It was reported that the injection of synvisc one was not effective (device ineffective; onset and latency: unknown).Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all the events.At time of reporting, the outcome was unknown for device ineffective; recovered for skin necrosis and hematoma; and recovering/ resolving for all other events.Additional information received on 21-jan-2022 from the pharmacist.Events of device ineffective and loss of personal independence in daily activities were added.Outcome updated.Medical history added.Clinical course updated and text amended accordingly.

Event Description

Skin necrosis [skin necrosis] ([skin pain], [burning sensation]).Hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg [hematoma].Injection of synvisc one was not effective [device ineffective].Case narrative: initial information from france received on 22-dec-2021 regarding an unsolicited valid serious case received from a pharmacist.This case involves 39 years old male patient who had skin necrosis, hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg, pain and burning on the left knee, consequences on daily life: yes, work disruption for 3 weeks and injection of synvisc one was not effective with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included right epicondyle tendinopathy ligamentoplasty of left knee with meniscectomy intrameniscal cyst of anterior horn and residual hernia orthosis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6)2021, the patient started using hylan g-f 20, sodium hyaluronate injection once for viscosupplementation (lot - brsl010b) (dose, route, expiry date: unknown).On an unknown date in (b)(6)2021 a hematoma appeared on the lateral border of the knee and on the anterior lateral aspect of the leg appeared (hematoma; latency: unknown).On (b)(6)2021 the patient returned in emergency and was found to have a large area of skin necrosis (onset: (b)(6)2021; latency: unknown; seriousness: medically significant) with pain (pain of skin; onset: (b)(6)2021; latency: unknown; seriousness: medically significant) and burning on the left knee (burning sensation; onset: (b)(6)2021; latency: unknown; seriousness: medically significant).This had a consequence on daily life, patient had work disruption for 3 weeks.No intra-articular effusion was observed.A dermatological opinion was required with the implementation of a local treatment as well as a biological control.Slowly positive progress was observed at the consultation on (b)(6)2021.It was reported that the injection of synvisc one was not effective (device ineffective; onset and latency: unknown).Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all the events.At time of reporting, the outcome was unknown for device ineffective; recovered for skin necrosis and hematoma; and recovering/ resolving for all other events.A product technical complaint (ptc) was initiated on (b)(6)2021 for synvisc-one (lot/batch number and expiration date: brsl010b) with global ptc number: (b)(4).The sample status was not available and the ptc was under investigation.Additional information received on 21-jan-2022 from the pharmacist.Events of device ineffective and loss of personal independence in daily activities were added.Outcome updated.Medical history added.Clinical course updated and text amended accordingly.Additional information was received on 22-dec-2021 from the quality department.Ptc details were added.Text amended accordingly.Additional information received on 26-jan-2022 from the patient.Event of loss of personal independence in daily activities was deleted.Clinical course updated and text amended.

Event Description

Skin necrosis [skin necrosis] ([skin pain], [burning sensation]).Hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg [hematoma].Injection of synvisc one was not effective [device ineffective].Case narrative: initial information from france received on 22-dec-2021 regarding an unsolicited valid serious case received from a pharmacist.This case involves 39 years old male patient who had skin necrosis, hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg, pain and burning on the left knee, consequences on daily life: yes, work disruption for 3 weeks and injection of synvisc one was not effective with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included right epicondyle tendinopathy ligamentoplasty of left knee with meniscectomy intrameniscal cyst of anterior horn and residual hernia orthosis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid (solution), strength 46mg/6ml once for viscosupplementation (lot - brsl010b) (dose, route, expiry date: unknown).On an unknown date in (b)(6) 2021 a hematoma appeared on the lateral border of the knee and on the anterior lateral aspect of the leg appeared (hematoma; latency: unknown).On (b)(6) 2021 the patient returned in emergency and was found to have a large area of skin necrosis (onset: (b)(6) 2021; latency: unknown; seriousness: medically significant) with pain (pain of skin; onset: (b)(6) 2021; latency: unknown; seriousness: medically significant) and burning on the left knee (burning sensation; onset: (b)(6) 2021; latency: unknown; seriousness: medically significant).This had a consequence on daily life, patient had work disruption for 3 weeks.No intra-articular effusion was observed.A dermatological opinion was required with the implementation of a local treatment as well as a biological control.Slowly positive progress was observed at the consultation on (b)(6) 2021.It was reported that the injection of synvisc one was not effective (device ineffective; onset and latency: unknown).Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all the events.At time of reporting, the outcome was unknown for device ineffective; recovered for skin necrosis and hematoma; and recovering/ resolving for all other events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc-one (lot/batch number and expiration date: brsl010b) with global ptc number: (b)(4).The sample status was not available.The production and quality control documentation for lot # brsl010b expiration date (2024-01) was 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 # brsl010b no capa 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) 2022 there are (b)(4) complaints on file for lot# brsl010 and all related sublots.(b)(4) complaints are on file for lot# brsl010b: (1) packaging damage and (1) adverse event report.(b)(4) complaint is on file for lot# brsl010: (1) blister damage.Sanofi will continue to monitor complaints to determine if a capa is required.Final investigation was completed on 14-feb-2022 and conclusion summarized as no assessment possible.Additional information received on 21-jan-2022 from the pharmacist.Events of device ineffective and loss of personal independence in daily activities were added.Outcome updated.Medical history added.Clinical course updated and text amended accordingly.Additional information was received on 22-dec-2021 from the quality department.Ptc details were added.Text amended accordingly.Additional information received on 26-jan-2022 from the patient.Event of loss of personal independence in daily activities was deleted.Clinical course updated and text amended.Additional information was received on 14-feb-2022 from the healthcare professional.Ptc results received and processed.Strength and formulation updated.Text amended accordingly.

Event Description

Skin necrosis [skin necrosis] ([skin pain], [burning sensation]).Hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg [hematoma].Injection of synvisc one was not effective [device ineffective].Case narrative: initial information from france received on (b)(6) -2021 regarding an unsolicited valid serious case received from a pharmacist.This case involves 39 years old male patient who had skin necrosis, hematoma on the lateral border of the knee and on the anterior lateral aspect of the leg, pain and burning on the left knee, consequences on daily life: yes, work disruption for 3 weeks and injection of synvisc one was not effective with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included right epicondyle tendinopathy ligamentoplasty of left knee with meniscectomy intrameniscal cyst of anterior horn and residual hernia orthosis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On 10(b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid (solution), strength 46mg/6ml once for viscosupplementation (lot - brsl010b) (dose, route, expiry date: unknown).On an unknown date in (b)(6) 2021 a hematoma appeared on the lateral border of the knee and on the anterior lateral aspect of the leg appeared (hematoma; latency: unknown).On 16(b)(6) 2021 the patient returned in emergency and was found to have a large area of skin necrosis (onset: (b)(6) 2021; latency: unknown; seriousness: medically significant) with pain (pain of skin; onset: (b)(6) 2021; latency: unknown; seriousness: medically significant) and burning on the left knee (burning sensation; onset: (b)(6) 2021; latency: unknown; seriousness: medically significant).This had a consequence on daily life, patient had work disruption for 3 weeks.No intra-articular effusion was observed.A dermatological opinion was required with the implementation of a local treatment as well as a biological control.Slowly positive progress was observed at the consultation on (b)(6) 2021.It was reported that the injection of synvisc one was not effective (device ineffective; onset and latency: unknown).Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all the events.At time of reporting, the outcome was unknown for device ineffective; recovered for skin necrosis and hematoma; and recovering/ resolving for all other events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc-one (lot/batch number and expiration date: brsl010b) with global ptc number: (b)(4).The sample status was not available.The production and quality control documentation for lot # brsl010b expiration date (2024-01) was 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 # brsl010b no capa 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 1(b)(6)2022 there are (b)(4) complaints on file for lot# brsl010 and all related sublots.(b)(4) complaints are on file for lot# brsl010b: (1) packaging damage and (1) adverse event report.(b)(4) complaint is on file for lot# brsl010: (1) blister damage.Sanofi will continue to monitor complaints to determine if a capa is required.Final investigation was completed on (b)(6) 2022 and conclusion summarized as no assessment possible.Additional information received on 21-jan-2022 from the pharmacist.Events of device ineffective and loss of personal independence in daily activities were added.Outcome updated.Medical history added.Clinical course updated and text amended accordingly.Additional information was received on 22-dec-2021 from the quality department.Ptc details were added.Text amended accordingly.Additional information received on 26-jan-2022 from the patient.Event of loss of personal independence in daily activities was deleted.Clinical course updated and text amended.Additional information was received on 14-feb-2022 from the healthcare professional.Ptc results received and processed.Strength and formulation updated.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: 13123637
• MDR Text Key: 288090714
• Report Number: 2246315-2021-00185
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2022

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: BRSL010B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/09/2022; 02/01/2022; 02/09/2022; 02/21/2022; 02/23/2022
• 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): Disability; Other; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male