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

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Injury (2348); Reaction, Injection Site (2442)

Event Type  malfunction  

Event Description

This unsolicited case was from united states was received on 12-mar-2018 from a physician.This case involves a patient (demographics: unknown) who received treatment with synvisc one and after unknown latency experienced "15-19" adverse events related to treatment.Also, device malfunction was identified for the reported lot number.No past drugs, medical history, concomitant medication or concurrent condition was reported.On an unknown date, the patient received treatment with intra-articular synvisc one injection (dose: not provided) once (batch/ lot number: 7rsl021 and expiration date: not provided) (indication: not provided).On an unknown date, after an unknown latency the patient experienced "15-19" adverse events related to treatment related to treatment.Physician was not able to provide the ae (adverse event) required reporting details at the time of the conversation.Corrective treatment: not reported.Outcome: unknown for both events.Reporter causality: related.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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment follow up dated 12-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced adverse events related to treatment.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.Also, detailed information regarding event will aid in further assessment of this case.

Event Description

Device malfunction [device malfunction]."15-19" adverse events related to treatment [unevaluable event].Pain in right knee [knee pain].Swelling in right knee [swelling of r knee].Case narrative: this unsolicited case was from united states was received on (b)(6) 2018 from a physician.This case involves a patient (demographics: unknown) who received treatment with synvisc one and on the same day had pain and swelling in right knee, after unknown latency experienced "15-19" adverse events related to treatment.Also, device malfunction was identified for the reported lot number.No past drugs or concurrent condition was reported.The concomitant medications included atropine sulfate (atropine sulfate); dextropropoxyphene napsilate (darvon); gemfibrozil (lopid); loperamide hydrochloride (lomotil [)operamide hydrochloride); lovastatin (lovastatin); fish oil (fish oil); venlafaxine hydrochloride (effexor); calcium (calcium); colecalciferol (vitamin d (colecalciferol); and triamcinolone acetonide (nasacort).The medical history included allergic rhinitis, dyslipidemia, osteoporosis, osteoarthritis.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml into the right knee once for osteoarthritis right knee (batch/ lot number: 7rsl021 and expiration date: not provided) (indication: not provided).The same day, the patient experienced pain and swelling into the right knee after receiving treatment with synvisc one.On an unspecified date, the patient recovered from pain and swelling of right knee.On an unknown date, after an unknown latency the patient experienced "15-19" adverse events related to treatment.Physician was not able to provide the ae (adverse event) required reporting details at the time of the conversation.Corrective treatment: not reported for all events.Outcome: unknown for 15-19" adverse events related to treatment; recovered for pain in right knee and swelling in right knee.Reporter causality: related.A product technical complaint 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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction.Follow up was received on 26-mar-2018.Gptc number was added.Text was amended accordingly.Follow up was received on 03-apr-2018.No new information was received.Additional information was received on 25-jun-2018 from the physician.The additional events of pain in right knee, swelling in right knee were added with details.The suspect product start date, dose and indication were added.The patient's demographic details were added.The medical history and concomitant medications were added.Clinical course updated.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7373559
• MDR Text Key: 103947616
• Report Number: 2246315-2018-00414
• 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
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 10/03/2018
• Patient Sequence Number: 1
• Treatment: ATROPINE SULFATE (ATROPINE SULFATE),; CALCIUM (CALCIUM),; DARVON N (DEXTROPROPOXYPHENE NAPSILATE),; EFFEXOR (VENLAFAXINE HYDROCHLORIDE),; FISH OIL (FISH OIL),; LOMOTIL [LOPERAMIDE HYDROCHLORIDE] (LOPERAMIDE HYD; LOPID (GEMFIBROZIL),; LOVASTATIN (LOVASTATIN),; NASACORT (TRIAMCINOLONE ACETONIDE),; VITAMIN D [COLECALCIFEROL] (COLECALCIFEROL),
• Patient Outcome(s): Other