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 Erythema (1840); Pain (1994); Swelling (2091)

Event Date 11/22/2017

Event Type  malfunction  

Event Description

Based on additional information received on (b)(4) 2017, this case initially considered as non-serious was upgraded to serious (important medical event of device malfunction).This case was cross reference with case ids: (b)(4) (cluster).This unsolicited case from united states was received on (b)(6) 2017 from other non-health care professional this case concerns a female patient (age unspecified) who received treatment with synvisc one and after 1 day had red knee, swollen knee, painful knee and had knee effusion.Also, device malfunction was identified for the reported lot number.No past drugs, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose, indication: not reported; lot number: 7rsl021 and expiration date: 31-may-2020) in unspecified knee.On (b)(6) 2017, after 1 day of receiving synvisc one injection, patient had knee effusions, with similar symptoms of red, swollen and painful.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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event of device malfunction additional information was received on (b)(4) 2017 (both processed with the clock start date of (b)(4) 2017).Global ptc number was added.Additional event of device malfunction was added with details.Seriousness criterion was added.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 16-dec-2017: this case concerns a patient who received synvisc one injection and later had knee pain, swelling, and redness.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, causal relationship to the events 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: 7150536
• MDR Text Key: 96844837
• Report Number: 2246315-2017-00479
• Device Sequence Number: 0
• Product Code: MOZ
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2017
• 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