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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Type  Injury  

Event Description

Ambulate with walker [gait inability] , pyogenic arthritis of left knee joint [arthritis pyogenic] ([fever], [knee pain]), device malfunction [device malfunction] , injection did not help [device ineffective].Case narrative: based on additional information received on 23-jul-2018, suspect product was updated from synvisc to synvisc-one.Initial information received on 12-jun-2018 regarding an unsolicited valid non-serious case received from united states via a physician.This case involves an (b)(6) female patient who experienced ambulate with walker and pyogenic arthritis of left knee joint, injection did not help and device malfunction after receiving treatment with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included hypertension, primary osteoarthritis of left knee and knee operation with right partial knee replacement.The patient's family history included hypertension with mother, myocardial infarction with mother and sibling and coronary artery disease with sibling.The patient's past medical treatment(s), vaccination(s) was not provided.On an unknown date, the patient started using synvisc-one via intra-articular frequency dosage 6ml 1x (lot:7rsl021 exp 31-may-2018) for osteoarthritis.On unknown date, patient reported that injection did not help.The patient also stated that she continued to have significant pain/acute pain of left knee which made her to ambulate with a walker.On an unknown date, patient developed pyogenic arthritis of left knee joint (latency: unknown) due to unspecified organism, which has been suspected to have occurred secondary to contaminated synvisc injection.The patient underwent left knee arthoscopy, irrigation, debridement, partial synovectomy and shaving chondroplasty for the same and was prescribed vancomycin and piperacillin & tazobactam (pip/tazo).The patient also complained of fever.Corrective treatment: walker for the ambulate with walker; left knee arthoscopy, irrigation, debridement, partial synovectomy and shaving chondroplasty, vancomycin and piperacillin & tazobactam (pip/tazo) for pyogenic arthritis of left knee joint.Outcome: not recovered for ambulate with walker and device malfunction; unknown for pyogenic arthritis of left knee joint.A product technical complaint (ptc) was initiated on 19-jun-2018 for synvisc batch number unknown (b)(4).The product lot number was not provided; therefore, a batch record review was 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 monitored 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 adverse events to determine if a capa was required.Seriousness criteria: disability for ambulate with walker; required intervention and medically significant for pyogenic arthritis of left knee joint and device malfunction.Additional information was received on 19-jun-2018.Global ptc number and ptc results were added.Text was amended accordingly.Additional information received on 23-jul-2018 from physician.Event of pyogenic arthritis of left knee joint, device malfunction and fever added with details.Suspect product updated from synvisc to synvisc-one and product details updated.Verbatim updated for significant pain to significant pain/acute pain of left knee and it was re-assessed as symptom of pyogenic arthritis of left knee joint.History of primary osteoarthritis of left knee added.Clinical course updated.Text amended accordingly.Follow up information was received on 30-jul-2018.No new information received.

• Brand Name: SYNVISC ONE
• 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: 7927011
• MDR Text Key: 122459034
• Report Number: 2246315-2018-00645
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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; Disability