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); Muscular Rigidity (1968); Pain (1994); Swelling (2091)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

Based on the information received on (b)(6) 2018, the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This case was cross reference with case id: (b)(4) (cluster).This unsolicited case from united states was received on (b)(6) 2017 from other health care professional (medical assistant).This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after an unknown latency patient had redness, inability to bear weight, tightness, swelling and pain.Also, 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 (dose and indication: not reported; lot number: 7rsl021 and expiration date: may-2020) in left knee.On an unknown date in (b)(6) 2017, after unknown latency, patient experienced swelling, redness, pain, tightness, inability to bear weight and emergency room visits.Corrective treatment: not reported for all events.Outcome: unknown for all events.(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.Seriousness criteria: important medical event for device malfunction.Additional information was received on (b)(6) 2018.This case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow-up dated (b)(6) 2018: this case concerns a patient who received treatment with synvisc one injection from the recalled lot and later experienced to have localised erythema, weight bearing difficulty, joint tightness, left knee swelling and left knee pain.Temporal relationship can be established between the events 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 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: 7276487
• MDR Text Key: 100533284
• Report Number: 2246315-2018-00305
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• 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: 02/02/2018
• 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
• Patient Age: 80 YR