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

Lot Number UNKNOWN

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

Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 11/05/2011

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2020: this case concerns a patient who was on treatment with synvisc one and reported that patient's right knee swell 3 times the normal size, had to have it drained 3 times in 1 week because of this reaction, had continuous pain and discomfort.The information in the case is very limited.Therefore, the causality with the device cannot be established.Further, detailed information regarding other medications, medical history and event clinical course would aid in comprehensive assessment of the case.

Event Description

Right knee swell 3 times the normal size, had to have it drained 3 times in 1 wk because of this reaction [effusion (r) knee] ([swelling of r knee], [discomfort in joints], [aching (r) knee]).Case narrative: initial information received on 14-dec- 2020 regarding an unsolicited valid serious case received from patient via health authorities of united states under reference mw5097904.This case involves an unknown age patient whose right knee swell 3 times the normal size, had to have it drained 3 times in 1 wk because of this reaction, 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 intra-articular injection of hylan g-f 20, sodium hyaluronate (dose, frequency, indication, lot - unknown, expiration date: 22-oct-2012).There will be no information available on the batch number for this case.On (b)(6) 2011, after unknown latency, the injection caused the right knee to swell 3 times the normal size and it had to be drained 3 times in 1 week because of this reaction (joint effusion with symptom of joint swelling).Patient now suffered with continuous pain everyday (arthralgia), having to take ibuprofen to give some comfort and was not sure when he/she would be free of this discomfort (musculoskeletal discomfort) (onset: (b)(6)2011).The event was assessed as important medical event (medically significant).Action taken: not applicable.Corrective treatment: ibuprofen.Outcome: not recovered.A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc one with unknown batch number and global ptc number: (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 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 will continue to monitor adverse events to determine if a capa was required.Final investigation was received on (b)(6) 2020.Additional information was received on (b)(6) 2020 from other healthcare professional.Global ptc number was added.Ptc results received and processed.

• 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: 11097568
• MDR Text Key: 229836917
• Report Number: 2246315-2020-00193
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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