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

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

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

Event Date 05/14/2013

Event Type  Injury  

Event Description

Pseudoseptic reactions [pseudosepsis] ([aching (r) knee], [swelling of r knee], [effusion (r) knee]).Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case from health authorities of united states under reference mw5097715 via other healthcare professional.This case involves adult male patient who experienced pseudoseptic reactions, while he was treated with hylan g-f 20, sodium hyaluronate [synvisc].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 osteoarthritis nos.In 2013, the patient started treatment with hylan g-f 20, sodium hyaluronate injection (strength: 48mg/6ml) via intra articular route (dose, frequency and batch number unknown) to reduce pain in affected knee.On (b)(6) 2013, after unknown latency, patient started experiencing right knee pain (arthralgia) and swelling (joint swelling) post injection and then contacted primary care clinic on an unknown date in 2013 with these complaints.Patient was seen by rheumatologist who performed injections and right knee arthrocentesis completed which showed 12cc of fluid that was removed from right knee.Patient instructed to continue naproxen for pain/inflammation and return to clinic 3 days later for follow up.Patient reported to ed (emergency department) over the weekend on an unknown date in 2013 with recurrent swelling and pain.Arthrocentesis again completed in ed which produced, 100cc of fluid (joint effusion).Patient was sent home from ed with as needed oxycodone/paracetamol.Again follow up with rheumatologist showed continued swelling of knee joint after which naproxen stopped and etodolac started.Next follow up with rheumatologist on an unknown date in 2013 stated improvement in knee swelling but continued knee pain despite trail of multiple nsaids.Patient was then referred to orthopedics for further treatments options and was scheduled for ortho follow up on an unknown date in 2013 as patient had symptoms of pseudoseptic reactions (pseudosepsis).All events were assessed as medically significant.Action taken: unknown.The patient was treated with naproxen, oxycodone, paracetamol (oxycodone/apap) and etodolac for pseudosepsis.The patient outcome is reported as unknown for pseudosepsis.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 21-jan-2021.Follow up information was received on 12-jan-2021 from the healthcare professional.Comet id number added.No significant information added.Additional information was received on 21-jan-2021 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text 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: 11235702
• MDR Text Key: 231945528
• Report Number: 2246315-2021-00038
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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): Other; Required Intervention