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 Inflammation (1932)

Event Date 10/01/2017

Event Type  malfunction  

Event Description

Based on additional information received on 30-mar- 2018, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as required intervention and previously reported nonserious event of pseudoseptic reaction was considered serious with seriousness criteria as required intervention.This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 28-dec-2017 from physician.This case concerns a female patient who received treatment with synvisc one and later after unknown latency had pseudoseptic reaction and fluid was aspirated from both knees.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection once (dose and indication: unknown) on both knees (batch/lot number: 7rsl021; expiration date: 30-sep-2020).On an unknown date in (b)(6) 2017, after unknown latency, patient had pseudoseptic reaction.On an unknown date in (b)(6) 2017, after unknown latency the patient's fluid was aspirated from both knees.It was reported that the physician injected cortisone to both knees.On (b)(6) 2017, the patient returned with both knees "blown up".The patient returned 2 weeks later on (b)(6) 2017 and was still inflamed and "angry".Physician drew fluid from the knee and sent it for "routine analysis" but nothing grew out.The last contact with this patient was on (b)(6) 2017, when patient stated that patient was "better" but still having pain.On an unknown date, the events resolved with no additional swelling.Corrective treatment: not reported for fluid was aspirated from both knees and device malfunction; cortisone.For pseudoseptic reaction.Outcome: recovered for all the events.Seriousness criteria: required intervention for device malfunction and pseudoseptic reaction.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 would be completed, corrective and preventive actions would be implemented.Additional information was received on 27-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 30-mar-2018 from the physician.This case initially considered nonserious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as required intervention and previously reported non-serious event of pseudoseptic reaction was considered serious with seriousness criteria as required intervention.Also the additional event of fluid was aspirated from both knees was added with details.The suspect product batch/lot number and expiry date was added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 30-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pseudoseptic reaction including swelling, pain, inflammation of knees and fluid was aspirated from both knees.A temporal relationship can be established with the product administration.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: 7431554
• MDR Text Key: 106024535
• Report Number: 2246315-2018-00447
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• 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: 03/30/2018
• 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): Required Intervention