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

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

Patient Problems Aspiration/Inhalation (1725); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 09/17/2018

Event Type  Injury  

Event Description

Pain (knee pain).Swelling/puffiness (knee swelling).Remove some of the liquid injected (knee effusion).Cannot put pressure on his knee (weight bearing difficulty).Nor can he walk (unable to walk).Case narrative: initial information received on 16-oct-2018 from united states valid serious case received from the patient.This case involves a (b)(6) years old male patient who experienced pain, swelling/puffiness (latency: same day), remove some of the liquid injected, cannot put pressure on his knee and nor can he walk (latency: unknown), while he was using 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 (b)(6) 2018, the patient started using synvisc dosage: 2 ml via intra-articular route at qw frequency (lot - unk) for osteoarthritis.On the same day, after few hours, patient experienced pain, swelling and puffiness.It was also reported that patient cannot put pressure on his knee and nor was able to walk.On the unknown date, patient had tried to remove some of the liquid injected and had tried injecting steroids.Final diagnosis was swelling/puffiness, pain, nor can he walk, cannot put pressure on his knee and remove some of the liquid injected.Action taken: drug withdrawn.Corrective treatment: steroids for the pain, swelling/puffiness and remove some of the liquid injected.Outcome: not recovered.A product technical complaint for synvisc was initiated on 22-oct-2018 with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no 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 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 will continue to monitor adverse events to determine if a capa was required.Seriousness criteria: intervention required for the pain, swelling/puffiness and remove some of the liquid injected.Additional information was received on 22-oct-2018.Ptc results received and processed.Global ptc number added.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8009580
• MDR Text Key: 125185459
• Report Number: 2246315-2018-00695
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/26/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2018
• 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
• Patient Age: 72 YR