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

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

Patient Problems Tingling (2171); Joint Swelling (2356); Reaction, Injection Site (2442); No Code Available (3191)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Limp around/ limping on a crutch [limping].Tingling in his knee [localized tingling].Swelling in his knee [knee swelling].Couple of bumps where the injection goes in [injection site joint swelling].Injections did not last very long [therapeutic response shortened].Case narrative: based on the information received on 26-feb-2020 the case was upgraded to serious as the patient was limping on a crutch (seriousness: disability).This case was linked to linked to case (b)(4) (same patient).Initial information received on 13-nov-2019 from united states regarding an unsolicited valid serious case from a patient via phone.This case involves a (b)(6) years old male patient who experienced tingling in his knee (latency: 1 month), limp around/ limping on a crutch (latency: 1 month), swelling in his knee (latency: 1 month) and couple of bumps where the injection goes in, injections did not last very long (latency: unknown), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included deteriorating cartilage in right knee that resulted from an accident in 1980s and 3 scopes of knee to clean out the debris.The patient had received 10-12 injections of synvisc one over the past years.The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.Patient reported he had to go through cortisone shots prior to approval for hylan g-f 20, sodium hyaluronate.On an unknown date in (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate, frequency once (dose, batch: unknown) (information for batch number was requested) for no cartilage left and meniscus tears.On an unknown date after the injection in 2019, patient reported he had a couple bumps when the injection goes in (latency: unknown) and they settled in couple weeks.The patient reported that the injection did not last very long (latency: unknown).On an unknown date in (b)(6) 2019, one month after the injection, patient had to limp around (latency: 1 month), had tingling (latency: 1 month) and swelling in his knee (latency: 1 month).It was reported that patient was limping of crutch after receiving synvisc one (seriousness: disability).Patient mentioned that he had appealed regarding the 6 months waiting period between the injections but was not successful and could not get the authorization to have the injections sooner.Action taken: not applicable for all the events.Corrective treatment: not reported for all the events.Outcome: recovered/resolved for couple of bumps where the injection goes in; not applicable for injections did not last very long; unknown for rest of the events.A product technical complaint was initiated on 22-nov-2019 for synvisc-one.Batch number: unknown global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Final investigation complete date: (b)(6) 2019.Follow up information received on 22-nov-2019 from other healthcare professional.No new information.Additional information received on 03-dec-2019 from other healthcare professional.Investigation summary received and ptc results added.Text amended accordingly.Additional information received on 26-feb-2020 from the patient.Indication added.Case was updated to serious.Verbatim of limp around was updated to limp around/ limping on a crutch.Clinical course was updated, and 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: 9793601
• MDR Text Key: 196430752
• Report Number: 2246315-2020-00046
• 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: health professional
• Type of Report: Initial
• Report Date: 03/04/2020

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: 03/05/2020
• 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