MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problem Reaction (2414)

Event Type  malfunction  

Event Description

This case was cross referenced with case (b)(4).This spontaneous case from united states was received on (b)(6) 2017 from other health care professional.This case concerns a patient (demographics: not provided) who initiated treatment with synvisc one and after an unknown latency had a reaction, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown date, patient received treatment with intra articular synvisc one injection once (dose, and indication: not provided).On an unknown date, after an unknown latency, had a reaction.Corrective treatment: not reported for both events.Outcome: unknown for device malfunction.Seriousness criteria: important medical event for device malfunction.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Pharmacovigilance comment: sanofi company comment dated 04-jan-2017: this case concern a female patient who received synvisc one injection from the recalled lot for knee pain and had a reaction to it.The concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the event to the products cannot be excluded.

Event Description

This case was cross referenced with case (b)(4).This spontaneous case from united states was received on 27-dec-2017 from other health care professional.This case concerns a patient (demographics: not provided) who initiated treatment with synvisc one and after an unknown latency had a reaction, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown date, patient received treatment with intra articular synvisc one injection once (dose, and indication: not provided).On an unknown date, after an unknown latency, had a reaction.Corrective treatment: not reported for both events outcome: unknown for device malfunction seriousness criteria: important medical event for device malfunction a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received on 02-jan-2018.Global ptc number was added.Follow up information was received on 15-jan-2018.No new information received.Additional information was received on 29-jan-2018.Related case id added.The events in the case were updated as adverse events of special interest (aesi).Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 15-jan-2018: no new follow up information received.This case concern a female patient who received synvisc one injection from the recalled lot for knee pain and had a reaction to it.The concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the event to the products cannot be excluded.

Event Description

This case was cross referenced with case (b)(4).This spontaneous case from united states was received on 27-dec-2017 from other health care professional.This case concerns a patient (demographics: not provided) who initiated treatment with synvisc one and after an unknown latency had a reaction, also, device malfunction was identified for the reported lot number.Patient present or past illness or medical problems included atrial fibrillation, hypertension, see cardiologist, glaucoma.Patient had history of stroke, breast carcinoma and arthritis.Surgical history included heart valve clips 2016 and gallbladder 2016.Patient was allergic to pain medications (pain medications make nauseated).Concomitant medications included triamcinolone acetonide (kenalog), lidocaine hydrochloride (xylocaine) and bupivacaine hydrochloride (sensorcaine) all in bilateral knees, atorvastatin calcium (lipitor), levothyroxine sodium (synthroid), warfarin, triamcinolone hexacetonide (aristospan), betamethasone, betamethasone (celestone), methylprednisolone acetate (depo-medrol), denosumab (prolia), hyaluronic acid (orthovisc), synvisc, hyaluronate sodium (hyalgan), hyaluronate sodium (euflexxa), lidocaine, bupivacaine hydrochloride (marcaine), bupivacaine, ketorolac tromethamine (toradol), pneumococcal conjugate vaccine (prevnar).On (b)(6) 2017 , patient received treatment with intra articular synvisc one injection once at a dose of 6 ml once in both the knees (batch number: 7rsl021; latency: may-2020 in the left knee; batch number: 7rsl015b; latency: apr-2020 in the right knee) for osteoarthritis left knee, bilateral knee pain and bilateral degenerative joint disease.Bilateral injections were given.On an unknown date, after an unknown latency, had a reaction.Patient had not been back to doctor's office since.No further information to provide.Corrective treatment: not reported for both events outcome: unknown for device malfunction seriousness criteria: important medical event for device malfunction a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51642 an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in (b)(6) 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received on 02-jan-2018.Global ptc number was added.Follow up information was received on 15-jan-2018.No new information received.Additional information was received on 29-jan-2018.Related case id added.The events in the case were updated as adverse events of special interest (aesi).Clinical course updated.Text was amended accordingly.Additional information was received on 19-mar-2018 from nurse.Therapy details of synvisc one were updated.Medical history, concomitant medications and concurrent conditions were added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 19-mar-2018: the follow-up information received doesnot alter the overall case assessment.This case concern a female patient who received synvisc one injection from the recalled lot for knee pain and had a reaction to it.The concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the event to the products cannot be excluded.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• MDR Report Key: 7211740
• MDR Text Key: 98423654
• Report Number: 2246315-2018-00061
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2018
• Patient Sequence Number: 1
• Treatment: ARISTOSPAN(CON.); BETAMETHASONE(CON.); BUPIVACAINE(CON.); CELESTONE(CON.); DEPO-MEDROL(CON.); EUFLEXXA(CON.); HYALGAN(CON.); KENALOG(CON.); LIDOCAINE(CON.); LIPITOR(CON.); MARCAINE(CON.); ORTHOVISC(CON.); PREVNAR(CON.); PROLIA(CON.); SENSORCAINE(CON.); SYNTHROID(CON.); SYNVISC(CON.); TORADOL(CON.); WARFARIN(CON.); XYLOCAINE(CON.)
• Patient Outcome(s): Other