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 Problems Erythema (1840); Pain (1994); Swelling (2091); Toxicity (2333)

Event Type  malfunction  

Event Description

Based upon additional information received on 06-dec- 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 is cross referred with the case (b)(4) (cluster).This unsolicited case from united states was received on 06-dec-2017 from an other health care professional.This case concerns a female patient (age not provided) who received treatment with synvisc one injection and after few hours had redness in both knees, pain in both knees and swelling in both knees; also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.On an unknown date, patient received treatment with intra- articular synvisc one injection (batch/lot number: 7rsl021 and expiration date, dose, frequency, indication: not provided) in both knees.On an unknown date (about 24 hours later), patient experienced pain, redness and swelling in both knees.No other data was reported.Action taken: unknown.Corrective treatment: not reported for all events.Outcome: unknown for all 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 would be completed.Corrective and preventive actions would be implemented.Seriousness criterion: important medical event (ime) for device malfunction additional information was received on 06-dec-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 experienced localized erythema, pain in both knees and swelling of knees 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, the causal relation 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: 7164884
• MDR Text Key: 96597286
• Report Number: 2246315-2017-00393
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 12/06/2017
• 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