MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problem Loss of Data (2903)

Patient Problems Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

(b)(4).This unsolicited case from united states was received on 19-jan-2018 from a non-healthcare professional.This case concerns an (b)(6) male patient who received treatment with synvisc one and later after unknown latency unable to walk at all/ can't ambulate, couldn't weight bare, severe pain, swelling and heat.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 at a dose of 1 df once for knee pain (batch/lot number: 7rsl021, expiry date: 31-may-2020).On an unknown date in 2017, after unknown latency, the patient was unable to walk at all, could not ambulate, couldn't weight bare, had severe pain, swelling and heat.On an unknown date in (b)(6) 2017, the patient was bought to be checked on.He was given an anti-inflammatory.It was reported that the patient still couldn't walk.On (b)(6) 2018, the patient came back and had a steroid injection and that calmed it down.Reportedly, the patient still couldn't walk.As on (b)(6) 2018, the patient was doing better.Corrective treatment: not reported for device malfunction; anti-inflammatory; steroid for rest all the events.Outcome: recovering for all the events.Seriousness criteria: required intervention for all the events.Pharmacovigilance comment: sanofi company comment dated 25-jan-2018: this case concerns a patient who received treatment with synvisc one from recalled lot and later experienced weight bearing difficulty, was unable to walk, right knee pain, right knee swelling and joint warmth.Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out with the product administration.Furthermore, the concerned lot has been identified to have malfunction by the company.Therefore, the causal relationship 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: 7246735
• MDR Text Key: 99801369
• Report Number: 2246315-2018-00222
• 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: consumer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/19/2018

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: Other
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/06/2018
• 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): Required Intervention
• Patient Age: 86 YR