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 Date 01/01/2017

Event Type  malfunction  

Event Description

Based upon additional information received on 22-nov- 2017, the case initially assessed as non-serious was upgraded to serious as the serious event of device malfunction with the seriousness criterion of important medical event was added.This case was cross referenced with cases: (b)(4) (cluster).This unsolicited case from united states was received on 22-nov-2017 from a non-healthcare professional.This case concerns a patient (demographics unspecified) who received treatment with synvisc one and after an unknown latency had "flare up," or an inflammatory reaction of some type/severe localized reactions in the knee joint; also, device malfunction was identified for the reported lot number.No medical history, past drugs, concomitant medication or concurrent condition was provided.On an unknown date in 2017, the patient received treatment with intra-articular synvisc one injection, once (dose, indication: not reported, batch/lot number: 7rsl021 and expiry date: 31-may-2020).On an unknown date in 2017, after unknown latency, patients experienced a "flare up," or an inflammatory reaction of some type, severe localized reactions in the knee joint after receiving the synvisc-one injection.It was reported that the patient went to the emergency room (er) for the knee reaction.Corrective treatment: not reported.Outcome: unknown.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) for device malfunction additional information was received on 05-dec-2017 from a non health care professional.Case was updated from 3 patients to a single patient case.The event term flare up," or an inflammatory reaction of some type was updated to flare up," or an inflammatory reaction of some type/severe localized reactions in the knee joint.Lot number and expiry date of synvisc one was added.Clinical course was updated and text was amended accordingly.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 was upgraded to serious.The ptc results were added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 21-dec-2017: this case concerns a patient who suffered from joint inflammation after receiving synvisc one injection from the recalled lot.Although exact event onset date has not been provided in the case, temporal relationship can still be established between the event and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, pharmacological plausibility of the event 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: 7142751
• MDR Text Key: 96346936
• Report Number: 2246315-2017-00360
• 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: consumer
• Reporter Occupation: Other
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/22/2017
• 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