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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problems Pain (1994); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

Based on additional information received on 05-dec-2017 (information was also received on 18-dec-2017; however processed together with clock start date 05-dec-2017), this case initially considered as non-serious was upgraded to serious as important medical event of device malfunction was added this case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on 05-dec-2017 from other non-health care professional this case concerns (b)(6) patient (gender unspecified) who received treatment with synvisc one and later after unknown latency patient could not walk, had left knee swelling and left knee pain.Patient also reported device malfunction.No medical history, past drugs, concomitant medication or concurrent condition was provided.On an unknown date, the patient initiated treatment with intra-articular synvisc one injection once (dose: unknown) (batch/lot number: 7rsl021, expiry date: 30- may-2020) for osteoarthritis in the left knee.It was the patient's first series.On an unknown date, after unknown latency, patient had swelling and pain and indicated they could not walk.They were going to have the patient come into the office.Corrective treatment: not reported for all events outcome: unknown for all events seriousness criteria: important medical event of device malfunction 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 was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Additional information was received on 05-dec-2017 and 18-dec-2017 (both information processed together with clock start date 05-dec-2017).Additional event of device malfunction was added along with details.Investigation summary results were added.Clinical course was updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 5-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later was unable to walk.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: 7357760
• MDR Text Key: 103529875
• Report Number: 2246315-2018-00408
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/30/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR