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

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

This case is cross referred with the case (b)(4) (cluster).This unsolicited case from united states was received on (b)(6) 2017 from a health care professional.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after unknown latency was unable to walk/could no longer ambulate at all for several days, severe knee pain/ global pain, knee swelling, numbness and tingling.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one bilateral injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: 31-may-2020; indication: not provided).On an unknown date in 2017, after unknown latency, patient was unable to walk and had severe pain and knee swelling, could no longer ambulate at all for several days, had global pain, numbness, and tingling.Patient was currently on a walker.No further information was provided.Corrective treatment: walker for unable to walk/could no longer ambulate at all for several days and not reported other events outcome: unknown for all events a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: disability for unable to walk/could no longer ambulate at all for several days pharmacovigilance comment: sanofi company comment dated 13-dec-2017: this case concerns a female patient who has received treatment with synvisc one and unable to walk/could no longer ambulate at all for several days.The event is temporally related with the device and therefore causal relationship with device cannot be denied.However, lack of information regarding patient's underlying medical condition and relevant medical history makes the complete case assessment difficult.

Event Description

This case is cross referred with the case (b)(4) (cluster).This unsolicited case from united states was received on 07-dec-2017 from a health care professional.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and after unknown latency was unable to walk/could no longer ambulate at all for several days, severe knee pain/ global pain, knee swelling, numbness and tingling.Also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one bilateral injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: 31-may-2020; indication: not provided).On an unknown date in 2017, after unknown latency, patient was unable to walk and had severe pain and knee swelling, could no longer ambulate at all for several days, had global pain, numbness, and tingling.Patient was currently on a walker.No further information was provided.Corrective treatment: walker for unable to walk/could no longer ambulate at all for several days and not reported other events outcome: unknown for all 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: disability for unable to walk/could no longer ambulate at all for several days and device malfunction additional information was received on 07-dec-02017 and 08-jan-2018 (both information processed together with clock start date of 07-dec-2017).Event of device malfunction was added.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company follow up comment dated 07-dec-2017: this case concerns a female patient who received treatment with synvisc one and was later unable to walk/could no longer ambulate at all for several days, experienced knee pain, knee swelling, numbness and tingling.Although exact event onset date has not been provided in the case, temporal relationship can still be established between the event and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, the 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: 7156225
• MDR Text Key: 96111343
• Report Number: 2246315-2017-00286
• 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: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2017
• 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
• Date Manufacturer Received: 12/07/2017
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 89 YR