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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)

Patient Problems Arthritis (1723); Toxicity (2333); Reaction (2414); No Code Available (3191)

Event Type  malfunction  

Event Description

Based on additional information received on 22-nov- 2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction with seriousness criteria as important medical event was added.This unsolicited summary case from united states was received on 06-nov-2017 from a physician.This case concerns 9 patients with unknown demographics who received treatment with synvisc one and later on the same day had pseudosepsis reaction and 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 patients initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml (batch/lot number: 7rsl021 and expiration date: 31-may-2020) for osteoarthritis.The same day, the patients had pseudosepsis reaction to synvisc one.Since an unknown date, after unknown latency, there was device malfunction.Corrective treatment: not reported for pseudosepsis reaction outcome: unknown for both the events seriousness criteria: important medical event for device malfunction a global pharmaceutical technical complaint (ptc) was initiated with 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 22-nov-2017.This case initially considered non-serious was upgraded to serious as the serious event of device malfunction with seriousness criteria as important medical event was added.The global ptc number with ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 13-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later had pseudosepsis.The events are temporally related with the device and therefore causal relationship with the device cannot be ruled out completely.

Event Description

Case narrative: this case is cross-referenced with the case ids (b)(4).Based on additional information received on 22-nov-2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction with seriousness criteria as medically significant was added.This unsolicited non-literature from united states was received on 06-nov-2017 from a physician.This case concerns a patient (age, gender: not provided) with unknown demographics who received treatment with synvisc one and later on the same day had pseudosepsis reaction and 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 initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml (batch/lot number: 7rsl021 and expiration date: 31-may-2020) for osteoarthritis.The same day, the patients had pseudosepsis reaction to synvisc one.Since an unknown date, after unknown latency, there was device malfunction.Corrective treatment: not reported for pseudosepsis reaction.Outcome: unknown for both the events.Seriousness criteria: medically significant for device malfunction.A product technical complaint (ptc) was initiated on 14-nov-2018 for synvisc one, batch number:7rsl021 , global ptc number: 50275.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 22-nov-2017.This case initially considered non-serious was upgraded to serious as the serious event of device malfunction with seriousness criteria as important medical event was added.The global ptc number with ptc results were added.Text was amended accordingly.Follow up was received on 15-dec-2017.No new information was received.Follow up was received on 28-nov-2018.No new information was received.Upon internal review on 07-jan-2019 the number of patient was updated and the related case ids were added.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7144207
• MDR Text Key: 96347657
• Report Number: 2246315-2017-00333
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/06/2019
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 11/22/2017
• Supplement Dates FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other