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 Arthritis (1723); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 28-may-2021: this case concerns a patient who was on treatment with synvisc one and had severe inflammatory reaction, cannot walk.The information in the case is very limited.Therefore, the causality with the device cannot be established.Further, detailed information regarding other medications, medical history and clinical course of the event would aid in comprehensive assessment of the case.

Event Description

Severe inflammatory reaction [joint inflammation].Cannot walk [unable to walk].Had knee synvisc one with depomedrol [wrong technique in device usage process].Case narrative: initial information received from (b)(6) on 26-may-2021 regarding an unsolicited valid serious case received from a physician.This case involves an unknown age male patient who had treatment in knee with hylan g-f 20, sodium hyaluronate (synvisc one) with depomedrol and experienced severe inflammatory reaction, cannot walk.The patient's past medical treatment included hyaluronidase 3cc and triamcinolone subsequently but no benefit.The patient's past medical history, vaccination(s) and family history were not provided.Concomitant medications included methylprednisolone acetate (depomedrol).On an unknown date, the patient started using synvisc one topical injection (lot, dose, frequency, indication - unknown).Information on the batch number was requested.Patient had knee synvisc one with depomedrol (wrong technique in device usage process, latency: same day).On an unknown date (unknown latency), patient had a severe inflammatory reaction (arthritis, event assessed as medically significant).Physician cultured his knee fluid twice with no infection.It was 8 weeks now and cannot walk (gait inability, onset: (b)(6) 2021, unknown latency: event assessed as medically significant).Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for the events of gait inability, arthritis.At time of reporting, the outcome was not applicable for wrong technique in device usage process, unknown for rest of the events.A product technical complaint was initiated and results were pending for the same.

Event Description

Severe inflammatory reaction [joint inflammation].Cannot walk [unable to walk].Had knee synvisc one with depomedrol [wrong technique in device usage process].Case narrative: based on information received on 18-jun-2021 the (b)(4) was identified as duplicate of case: (b)(4).All the information from the case: (b)(4) was be merged into the case: (b)(4).This case was cross linked with case: (b)(4) (duplicate).Initial information received from canada on 26-may-2021 regarding an unsolicited valid serious case received from a physician.This case involves an unknown age male patient who had treatment in knee with hylan g-f 20, sodium hyaluronate (synvisc one) with depomedrol and experienced severe inflammatory reaction, cannot walk.The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included methylprednisolone acetate (depomedrol).On an unknown date, the patient started using synvisc one topical injection (lot, dose, frequency, indication - unknown).Information on the batch number was requested.Patient had knee synvisc one with depomedrol (wrong technique in device usage process, latency: same day).On an unknown date (unknown latency), patient had a severe inflammatory reaction (arthritis, event assessed as medically significant).Physician cultured his knee fluid twice with no infection.It was 8 weeks now and cannot walk (gait inability, onset: on (b)(6) 2021, unknown latency: event assessed as medically significant).Action taken: not applicable for all events.Corrective treatment: hyaluronidase 3cc and triamcinolone subsequently but no benefit for the events of gait inability, arthritis.At time of reporting, the outcome was not applicable for wrong technique in device usage process, unknown for rest of the events.A product technical complaint (ptc) was initiated on 26-may-2021 for synvisc (lot number unknown) with global ptc number: 100129426.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no corrective and preventive action (capa) was required.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 non-conformance report (ncr) process.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 had not indicated any safety issue.Sanofi would continue to monitor complaints to determine if a capa is required.Final investigation was completed on 10-jun-2021.Based on information received on 18-jun-2021, the (b)(4) was identified as duplicate of case: (b)(4).All the information from the (b)(4) was be merged into the case: (b)(4).

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11906917
• MDR Text Key: 266860618
• Report Number: 2246315-2021-00109
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPOMEDROL (METHYLPREDNISOLONE ACETATE),UNKNOWN; DEPOMEDROL (METHYLPREDNISOLONE ACETATE),UNKNOWN
• Patient Outcome(s): Other; Required Intervention