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

Lot Number ARSP003

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

Patient Problems Inflammation (1932); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Knees would get "angry" usually after first injection.[unspecified disorder of knee joint] ([knee swelling], [rash nos], [joint warmth], [arthrocentesis]).Case narrative: initial information received on 11-jan-2022 from united states regarding an unsolicited valid serious case received from a other health professional.This case involves adult and unknown gender patient who experienced knees would get "angry" usually after first injection with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection (lot - arsp003) (route, batch number, indication, frequency: unknown).On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced swelling (joint swelling), warm knee (joint warmth) and rashes (rash).Patient experienced that patient's knee would get "angry" usually after first injection (arthropathy) patient had aspiration and aspirate was analyzed to assess cause when cloudy (aspiration joint).Action taken: unknown.It was not reported if the patient received a corrective treatment for the events (swelling, rashes, warm knee, knees would get "angry" usually after first injection, aspirate was analyzed to assess cause when cloudy).Outcome: recovered.

Event Description

Knees would get "angry" usually after first injection.[unspecified disorder of knee joint] ([knee swelling], [rash nos], [joint warmth], [arthrocentesis]) case narrative: initial information received on 11-jan-2022 from united states regarding an unsolicited valid serious case received from a other health professional.This case involves adult and unknown gender patient whose knees would get "angry" usually after first injection with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (synvisc) injection, liquid (solution) (strength: 16 mg/2 ml) (lot - arsp003; expiry date: 31-mar-2022) (route, indication, frequency: unknown).On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced swelling (joint swelling), warm knee (joint warmth) and rashes (rash).Patient experienced that patient's knee would get "angry" usually after first injection (arthropathy)patient had aspiration and aspirate was analyzed to assess cause when cloudy (aspiration joint).Action taken: unknown for all events it was not reported if the patient received a corrective treatment for the events (swelling, rashes, warm knee, knees would get "angry" usually after first injection., aspirate was analyzed to assess cause when cloudy).Outcome: unknown for aspiration joint; recovered for rest of the events a product technical complaint (ptc) was initiated on 11-jan-2022 for synvisc (batch number: arsp003) with global ptc number: (b)(4).The sample status was not available.Ptc status: complaint: adverse "events" on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, 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.(tj 16jun2023) investigation (tj 16jun2023) batch # arsp003, synvisc was manufactured on 11apr2019 with expiration date of 31mar2022 yielding (b)(4) kits.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 was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was 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 10 complaints for mother lot arsp003 and sub-batches.(b)(4) arsp003 adverse event (b)(4) arsp003 adverse event (b)(4) arsp003 leaking component (not active product) (b)(4) arsp003 syringe broken before use (b)(4) arsp003b adverse event (b)(4) arsp003b adverse event (b)(4) arsp003 adverse event (b)(4) arsp003 injection site inflammation (b)(4) arsp003c other adverse reaction nos (b)(4) arsp003 adverse event this review has not indicated any safety issue.Based on investigation and trend analysis, no capa (corrective and preventive action) required.Sanofi would continue to adverse events.Trend analysis would be performed on a periodic basis to determine if a capa was required.The final investigation for the ptc was completed on 16-jun-2023 with summarized conclusion as 'no assessment possible'.Additional information received on 27-jul-2022 from patient via health authority.The collecting organization updated.Text amended accordingly.Additional information was received on 11-jan-2022 from quality department via other healthcare professional.Suspect formulation, strength and global ptc number were added.Text amended accordingly.Additional information was received on 16-jun-2023 from quality department via other healthcare professional.Ptc results added.Text amended accordingly.

Event Description

Knees would get "angry" usually after first injection.[unspecified disorder of knee joint] ([knee swelling], [rash nos], [joint warmth], [arthrocentesis]) case narrative: initial information received on 11-jan-2022 from united states regarding an unsolicited valid serious case received from a other health professional.This case involves adult and unknown gender patient whose knees would get "angry" usually after first injection with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (synvisc) injection, liquid (solution) (strength: 16 mg/2 ml) (lot - arsp003; expiry date: 31-mar-2022) (route, indication, frequency: unknown).On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced swelling (joint swelling), warm knee (joint warmth) and rashes (rash).Patient experienced that patient's knee would get "angry" usually after first injection (arthropathy)patient had aspiration and aspirate was analyzed to assess cause when cloudy (aspiration joint).Action taken: unknown for all events it was not reported if the patient received a corrective treatment for the events (swelling, rashes, warm knee, knees would get "angry" usually after first injection., aspirate was analyzed to assess cause when cloudy).Outcome: unknown for aspiration joint; recovered for rest of the events a product technical complaint (ptc) was initiated on 11-jan-2022 for synvisc (batch number: arsp003) with global ptc number: 100334222.The investigation results are pending additional information received on 27-jul-2022 from patient via health authority.The collecting organization updated.Text amended accordingly.Additional information was received on 11-jan-2022 from quality department via other healthcare professional.Suspect formulation, strength and global ptc number were added.Text amended accordingly.

• 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: 13314147
• MDR Text Key: 289186892
• Report Number: 2246315-2022-00006
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

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 Expiration Date: 03/31/2022
• Device Lot Number: ARSP003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/14/2023; 06/20/2023
• 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