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

Device Problem Microbial Contamination of Device (2303)

Patient Problems Joint Swelling (2356); No Code Available (3191)

Event Type  Injury  

Event Description

On walker for 10 days [walking disability]; couldn't bend [joint range of motion decreased] ; knee swelled [knee swelling].Case narrative: this case was cross referred with cases: (b)(4) (cluster).Initial information received from united states on (b)(6) 2018 regarding an unsolicited valid serious case received from patient via social media.This case involves adult patient who was on a walker for 10 days, knees swelled while he/she was treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2018, the patient received intra-articular synvisc one injection once dosage and indication unknown (lot - unknown).Patient reported that he/she was on a walker for 10 days, knees were swelled so they could not bend (onset and latency: unknown).Final diagnosis was on a walker for 10 days, could not bend, knee swelled.Patient used walker for on a walker for 10 days.It was not reported if the patient received a corrective treatment for other events the patient outcome is reported as unknown for all events seriousness criteria: disability for on a walker for 10 days a product technical complaint (ptc) was initiated on 22-aug-2018 for 'synvisc one'.Batch number; unknown, local ptc number: not provided, 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 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 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.Additional information received on 22-aug-2018.Global ptc number was received, and results were added.Event of device malfunction was deleted from the case, as lot number for the device was updated to unknown.

• 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: 7927193
• MDR Text Key: 122371077
• Report Number: 2246315-2018-00520
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• 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
• Was Device Available for Evaluation?: No
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability