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 Pain (1994); Toxicity (2333); Joint Swelling (2356); No Code Available (3191)

Event Type  malfunction  

Event Description

Based on the information received on 08-dec-2017 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 08-dec-2017 from a healthcare professional.This case concerns a (b)(6) years old male patient who received treatment with synvisc one and later after unknown latency had elevated pain/ extreme pain, stiffness, joint swelling and had joint aspiration.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021, expiry date: may-2020).On an unknown date, after unknown latency, the patient had elevated pain, extreme pain, stiffness, joint swelling and joint aspiration.It was reported that the patient was being monitored.If the patient had infection he might get the surgery done.Action taken: unknown.Corrective treatment: joint aspiration for the event of "joint aspiration" (joint effusion); not reported for rest of the events.Outcome: unknown for all the 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 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 08-dec-2017 and 08-jan-2018 (processed with clock start date of (b)(6) 2017).Global ptc number and ptc results were added.An additional event of device malfunction was added with details.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for dated 8-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later had joint pain, stiffness, swelling and effusion.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, 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: 7194798
• MDR Text Key: 98184783
• Report Number: 2246315-2018-00137
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/08/2017

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: Health Professional
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/16/2018
• 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: 71 YR