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) (second 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, hypertension nos (not otherwise specified) for 2 years and seasonal allergies.It was reported that patient was 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 first 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 on 14-dec-2020 for synvisc for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.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-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 14-dec-2020.Additional information was received on 14-dec-2020 from health care professional.Global ptc number was added.Text was amended accordingly.Additional information was received on 04-jan-2021 from healthcare professional.Investigational results were added.Text amended accordingly.
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