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

Lot Number UNKNOWN

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

Patient Problems Therapeutic Response, Decreased (2271); Arthralgia (2355); No Code Available (3191)

Event Date 01/01/2003

Event Type  Injury  

Event Description

Burning up but had no fever [feeling hot].Excruciating pain (right knee) [aching (r) knee].Synvisc treatments have only lasted for 4.5 months [drug effect decreased].Case narrative: initial information received on 14-dec-2020 regarding an unsolicited valid serious case received from non healthcare professional via health authorities of united states under reference mw5097794.This case is cross-referenced with (b)(4) (first injection left knee for 5th series), (b)(4) (second injection left knee for 5th series), (b)(4) (third injection left knee for 5th series), (b)(4) (first injection right knee for 5th series), (b)(4) (4th series injection), (b)(4)(third injection right knee for 5th series) (multiple devices).This case involves an unknown age female patient who was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc) and experienced excruciating pain (right knee), burning up but had no fever and synvisc treatments have only lasted for 4.5 months.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing hypothyroidism for 4 years (1999), hypertension nos (not otherwise specified) for 2 years (2001) and seasonal allergies (not allergic to birds, feathers or eggs).Patient previously has 4 series of hylan g-f 20, sodium hyaluronate injections (from 2001 to 2002) for localized osteoarthritis.Concomitant medications included acetate tablet, levothyroxine sodium (synthroid); fexofenadine hydrochloride (allegra) and ramipril (altace).On an unknown date in 2003, the patient started 5th series of intra-articular injection of hylan g-f 20, sodium hyaluronate at the dose of 2 ml every week for 2 weeks in right knee (lot - unknown) for localized osteoarthritis.There will be no information available on the batch number for this case.On an unknown date in 2003 (by 11:00), after the second injection, patient had excruciating pain (arthralgia) and was burning up but had no fever (feeling hot) (latency: unknown).Patient missed next 2 days of work and used a cane.It was also reported that the hylan g-f 20, sodium hyaluronate treatment only lasted for 4.5 months (therapeutic product effect decreased, onset: 2003, latency: unknown).Events of arthralgia and feeling hot were assessed as serious due to disability.Action taken: not applicable for therapeutic product effect decreased, no action taken for rest of the events.It was not reported if the patient received a corrective treatment.Outcome: not applicable for therapeutic product effect decreased, unknown for rest of the events.A product technical complaint (ptc) was initiated with global ptc number (b)(4) on 14-dec-2020 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: 04-jan-2021.Follow up was received on 14-dec-2020 from healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 04-jan-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.

• Brand Name: SYNVISC
• 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: 11116378
• MDR Text Key: 231579685
• Report Number: 2246315-2021-00012
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• 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