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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)

Patient Problems Inflammation (1932); Reaction (2414)

Event Type  malfunction  

Event Description

Based on additional information received on 22-nov- 2017, this case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.This case was cross reference with case id: (b)(4) (cluster).This unsolicited case from united states was received on 21-nov-2017 from other health care professional.This case concerns 3 patients (demographics unspecified) who received treatment with synvisc one injection and after an unknown latency patient had allergic like reaction presented like pseudosepsis to the knee.Also, device malfunction was identified for the reported lot number.No relevant concomitant medications, past drugs, medical history and concurrent conditions were reported.On an unknown date, patients received treatment with intra- articular synvisc one injection, once (dose, expiration date and indication: not provided; batch/lot number: 7rsl021).On an unknown date, latency unknown, patients had an allergic like reaction presented like pseudosepsis to the knee.It was reported on all 3 patients.Corrective treatment: not reported for both events.Outcome: unknown for both events.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 was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction follow up was received on 04-dec-2017.No new information was received.Additional information was received on 22-nov-2017.This case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.Event of device malfunction was added.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 22-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced allergic reaction.A temporal relationship cannot be established with the product administration since event onset date and therapy details were unknown.In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product 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
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7142527
• MDR Text Key: 96346377
• Report Number: 2246315-2017-00353
• Device Sequence Number: 0
• Product Code: MOZ
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other