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 Problem Reaction (2414)

Event Type  malfunction  

Event Description

Based upon additional information received on 22-nov- 2017, the case became valid as the serious event of device malfunction with the seriousness criterion of important medical event was added and the case initially assessed as non-serious was also upgraded to serious.This case was cross referenced with case: (b)(4) (cluster).This unsolicited non-valid case from united states was received on 20-nov-2017 from a nurse.This case concerns 6 patients of unknown demographics who received treatment with synvisc one and later after unknown latency had adverse reactions (unevaluable event); also, device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patients initiated treatment with intra-articular synvisc one injection once (dose and indication: unknown) (batch/lot number: 7rsl021, expiry date: 31-may-2020).On an unknown date, after unknown latency, the patients experienced adverse reactions (unevaluable event).Corrective treatment: not reported.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.Seriousness criterion: important medical event (ime) additional information was received on 28-nov-2017.Related cases were added.Product lot number was updated from 7rsl01 to 7rsl021.Text was amended accordingly.Seriousness criterion: important medical event (ime) for device malfunction.Additional information was received on 22-nov-2017.The serious event of device malfunction with the seriousness criterion of ime was added and the case became valid and was upgraded to serious.The ptc results were added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 22-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later had an adverse reaction.A temporal relationship cannot be established with the product administration.However, the concerned lot number has been identified to have malfunctioned by the company.Therefore, the causal relationship of the events 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
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7143825
• MDR Text Key: 96243266
• Report Number: 2246315-2017-00330
• 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: 11/20/2017

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: Other
• 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
• 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