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

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

Patient Problems Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

She was on crutches for two to three days [crutch user] was not able to bend her knees [joint range of motion decreased] knees became extremely swollen [swelling of r knee].Case narrative: this case is submitted following an incorrect worldwide id in case id ((b)(4)) which will be deleted.This report contains no new information.This case was cross lined with case (b)(4) (same patient).Initial information received on 04-feb-2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc one.This case involves adult female patient who was on crutches for two to three days, was not able to bend her knees and knees became extremely swollen, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate at a dose of 6 ml once (lot and route - unknown) for osteoarthritis and tendinitis in right knee.On an unknown date after unknown latency, patient's knees became extremely swollen (joint swelling) and she was not able to bend her knees (joint range of motion decreased) and patient was on crutches for two to three days (walking aid user).Action taken: not applicable for all.It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered / resolved on an unknown date for all.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product.Batch number; unknown.Device not returned.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) 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 (non-conformance report) 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 is required.Final investigation complete date: 10-feb-2021.Reporter causality: not reported for all company causality: reportable for all.Additional information was received on 10-feb-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.Follow up received on 03-mar-2021 from healthcare professional.Compliant (b)(4) was re-opened due to incomplete information.No significant information received.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• 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: 11974157
• MDR Text Key: 264822846
• Report Number: 2246315-2018-00888
• 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,s
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability