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); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

Based upon additional information received on 22-nov- 2017, the case initially assessed as non-serious was upgraded to serious as the serious event of device malfunction with the seriousness criterion of important medical event was added.This case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on 21-nov-2017 from the other non-health care professional.This case concerns a (b)(6) year old male patient who received treatment with synvisc one injection and after unknown latency the patient experienced right knee pain and right knee swelling; also, device malfunction was identified for the reported lot number.No relevant medical history, past medications and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once (dose, indication and expiration date: not reported; lot number: 7rsl021).On an unknown date in (b)(6) 2017, unknown latency of receiving the injection the patient experienced right knee pain and knee swelling.Corrective treatment: not reported for all 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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event (ime) for device malfunction additional information was received on 22-nov-2017.The serious event of device malfunction with the seriousness criterion of ime was added and the case was upgraded to serious.The ptc results were added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 22-nov-2017: this case concerns a patient who received treatment with synvisc one and later experienced right knee pain and right knee swelling.A temporal relationship can be established with the product administration.Also, the concerned lot number has been identified to have malfunction by the company.Thus, 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: 7144586
• MDR Text Key: 96392185
• Report Number: 2246315-2017-00364
• 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: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 11/22/2017
• 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: 60 YR