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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Necrosis (1971); Arthralgia (2355); Embolism/Embolus (4438); Localized Skin Lesion (4542)

Event Type  Injury  

Event Description

Hyaluronic acid embolus in left knee following intra-articular injection [embolus] ([epidermal necrosis], [pain in knee], [discoloration skin], [localised pruritus], [localised erythema]).Case narrative: initial information received from united states on 07-oct-2022 regarding an unsolicited valid serious case issued from a literature article: wong sl, rehal br, kiuru m.Hyaluronic acid embolus following intra-articular injection.J cutan pathol.2022 ;49(10) :842-4.Digital object identifier: 10.1111/cup.14036.This case involves a 60-year-old female (in 60s) patient who experienced hyaluronic acid embolus in left knee following intra-articular injection while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of report, patient had ongoing medical history of osteoarthritis and had received a hyaluronic acid injection (hylan g-f 20, sodium hyaluronate) intraarticularly (dose, form, frequency, batch/lot details: unknown) to left knee for osteoarthritis.On an unknown date, one month after injection, patient presented with a one-week history (latency: 3 week) of a mildly pruritic (pruritus) and tender lesion on the left lateral knee.The patient noticed worsened symptoms in cold temperatures or with pressure.Physical examination revealed a 9 cm x 8 cm erythematous to violaceous reticular, partially blanchable patch on the left lateral knee.On examination, the patient was well-appearing and afebrile.A punch biopsy was performed.Microscopic examination showed epidermal necrosis and bluish material, consistent with hyaluronic acid (epidermal necrosis), occluding vessels in the dermis.A diagnosis of hyaluronic acid embolus (embolism) was rendered.The patient was given 130 units of hyaluronidase injected into the left lateral knee.Immediate improvement of pain (arthralgia) and discoloration (skin discolouration) was observed.Subsequent 150 and 300 units of hyaluronidase were injected at 60-minute intervals.The patient was advised to continue massaging and elevating leg with the goal of decreasing remaining erythema (erythema).Seriousness: medically significant.Action taken: unknown.Corrective treatment: hyaluronidase and massaging and elevating leg.Outcome: recovering.Reporter causality: related.

Event Description

Hyaluronic acid embolus in left knee following intra-articular injection [embolus] ([pain in knee], [discoloration skin], [localised pruritus], [localised erythema], [epidermal necrosis]).Case narrative: initial information received from united states on 07-oct-2022 regarding an unsolicited valid serious case issued from a literature article: wong sl, rehal br, kiuru m.Hyaluronic acid embolus following intra-articular injection.J cutan pathol.2022 ;49(10) :842-4.Digital object identifier: 10.1111/cup.14036.This case involves a 60-year-old female (in 60s) patient who experienced hyaluronic acid embolus in left knee following intra-articular injection while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.It is unknown if the patient had any medical history, concomitant disease or risk factor.At the time of report, patient had ongoing medical history of osteoarthritis and had received a hyaluronic acid injection (hylan g-f 20, sodium hyaluronate) intraarticularly (dose, form, frequency, batch/lot details: unknown) to left knee for osteoarthritis.On an unknown date, one month after injection, patient presented with a one-week history (latency: 3 week) of a mildly pruritic (pruritus) and tender lesion on the left lateral knee.The patient noticed worsened symptoms in cold temperatures or with pressure.Physical examination revealed a 9 cm x 8 cm erythematous to violaceous reticular, partially blanchable patch on the left lateral knee.On examination, the patient was well-appearing and afebrile.A punch biopsy was performed.Microscopic examination showed epidermal necrosis and bluish material, consistent with hyaluronic acid (epidermal necrosis), occluding vessels in the dermis.A diagnosis of hyaluronic acid embolus (embolism) was rendered.The patient was given 130 units of hyaluronidase injected into the left lateral knee.Immediate improvement of pain (arthralgia) and discoloration (skin discolouration) was observed.Subsequent 150 and 300 units of hyaluronidase were injected at 60-minute intervals.The patient was advised to continue massaging and elevating leg with the goal of decreasing remaining erythema (erythema).It is unknown if the patient experienced any additional symptoms/events medication details and reason for taking the medicine: synvisc.It is unknown if there were lab data/results available.Seriousness: medically significant.Action taken: unknown.Corrective treatment: hyaluronidase and massaging and elevating leg.Outcome: recovering.Reporter causality: related.A product technical complaint (ptc) was initiated on 27-oct-2022 for synvisc one.Batch number: unknown; gptc number: (b)(4).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 global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without product 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.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa is required.Additional information was received on 27-oct-2022 from affiliate: no new significant information was received.Additional information was received on 27-oct-2022 from affiliate: details added 'a product technical complaint was initiated on 27-oct-2022 with gptc number (b)(4) and results are pending for same'.Additional information was received on 27-oct-2022 from affiliate: details added 'a product technical complaint was initiated on 27-oct-2022 with gptc number (b)(4) and results are pending for same'.Additional information was received 17-nov-2022 from affiliate: results of gptc number (b)(4) (patient 1 and 2 respectively) have been completed.No significant information added.Additional information was received 18-nov-2022 from affiliate: results of gptc number (b)(4) (patient 5) have been added.Additionally results of gptc number (b)(4) (patient 4 and 3 respectively) have been completed.

• 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; a; bridgewater 08807
• MDR Report Key: 15679083
• MDR Text Key: 302473844
• Report Number: 2246315-2022-00131
• 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: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female