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

Lot Number 7RSL021

Device Problems Contamination (1120); Nonstandard Device (1420); Device Contamination With Biological Material (2908)

Patient Problems Bacterial Infection (1735); No Code Available (3191)

Event Type  malfunction  

Event Description

(b)(4).This unsolicited summary case from united states was received on 28-feb-2018 from a doctor.This case involves 7 patients (demographics not provided) who received treatment with synvisc one and after unknown latency experienced bacteria from the recalled synvisc one shots.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On unknown dates, the patients received treatment with intra-articular synvisc one injection (dose, frequency, indication: not provided).On unknown dates, after unknown latencies, the patients had bacteria from the recalled synvisc one shots.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event.Pharmacovigilance comment: sanofi company comment dated 8-mar-2018: this case concerns a patient who received treatment with synvisc one and later experienced joint infection.Although a significant temporal relationship cannot be established, causal role of suspect product in occurrence of the event cannot be denied.However, information regarding medical history, concomitant medications, past drugs, event details will aid in medical assessment of the case.

Event Description

This case is cross referenced with case id (b)(4).(cluster).This unsolicited summary case from united states was received on 28-feb-2018 from a doctor.This case involves 7 patients (demographics not provided) who received treatment with synvisc one and after unknown latency experienced bacteria from the recalled synvisc one shots.Also device malfunction was noted in reported lot number.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On unknown dates, the patients received treatment with intra-articular synvisc one injection (lot number: 7rsl021, dose, frequency, indication, expiration date: not provided).On unknown dates, after unknown latencies, the patients had bacteria from the recalled synvisc one shots.Action taken: unknown corrective treatment: not reported for bacteria from the recalled synvisc one shots outcome: unknown for both events a product technical complaint was initiated with global ptc number (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled 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.Seriousness criteria: important medical event for both events additional information on 26-mar-2018 from health care professional.Event of device malfunction was added.Global ptc number received and results processed.Pharmacovigilance comment: sanofi company commenty for follow up dated (b)(6) 2018:the follow up information does not change the previous case assessment.This case concerns a patient who received treatment with synvisc one and later experienced joint infection.Although a significant temporal relationship cannot be established, causal role of suspect product in occurrence of the event cannot be denied.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, pharmacological plausibility 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
• MDR Report Key: 7334417
• MDR Text Key: 102314452
• Report Number: 2246315-2018-00395
• 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,Followup
• Report Date: 02/28/2018

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 Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/11/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other