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 Swelling (2091); Toxicity (2333); Reaction (2414)

Event Type  malfunction  

Event Description

Based on the information received on 30-mar-2018 the case was upgraded to serious as an important medical event of device malfunction was added.This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 28-dec-2017 from physician.This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency right knee had some mild swelling but the left was very swollen, aspirate and bad pseudoseptic reaction.A device malfunction was noted for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection at a dose of 6 ml once (indication: unknown) bilaterally (left knee only received affected lot) (lot number: 7rsl021; expiry date: 30-sep-2020).On an unknown date in 2017, after unknown latency, the patient's right knee had some mild swelling but the left was very swollen.It was reported that the aspirate also did not grow out.On an unknown date in 2017, after unknown latency, the patient had bad pseudoseptic reaction.As of (b)(6) 2017, the patient was doing good.Corrective treatment: not reported for all the events outcome: unknown for device malfunction; recovering for other events a pharmaceutical technical complaint (ptc) was initiated with (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 14-mar-2018.Ptc results and global ptc number were added.Text was amended accordingly.Additional information was received on 30-mar-2018.Event of device malfunction was added.Lot number was added.Clinical course was updated and text amended accordingly.

• 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: 7403475
• MDR Text Key: 105252368
• Report Number: 2246315-2018-00444
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/28/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/06/2018
• 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): Other
• Patient Age: 62 YR