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 Unspecified Infection (1930)

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(6) 2017 from a healthcare professional.This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency had infection, had elevated pain, extreme pain, stiffness, joint swelling and had joint aspiration.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021; expiry date: may-2020).On an unknown date, after unknown latency the patient had elevated pain (extreme pain), stiffness, joint swelling, infection and joint aspiration.On an unknown date, after unknown latency the patient had to go get a surgery for infection and had to get synvisc one flushed out.Action taken: unknown corrective treatment: surgery and synvisc one flushed out for infection; synvisc one flushed out for rest of the events outcome: unknown for all the events seriousness criteria: required intervention for all the events a pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Pharmacovigilance comment: sanofi company comment dated 14-dec-2017: this case concerns a patient who received synvisc one injection and later had infection for which patient had surgery.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors will aid in complete medical case assessment.

Event Description

This unsolicited case from united states was received on 08-dec-2017 from a healthcare professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later after unknown latency had infection, had elevated pain, extreme pain, stiffness, joint swelling and had joint aspiration, also, device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021; expiry date: may-2020).On an unknown date, after unknown latency the patient had elevated pain (extreme pain), stiffness, joint swelling, infection and joint aspiration.On an unknown date, after unknown latency the patient had to go get a surgery for infection and had to get synvisc one flushed out.Action taken: unknown.Corrective treatment: surgery and synvisc one flushed out for infection; not reported for device malfunction.Outcome: unknown for both the events.Seriousness criteria: required intervention for both 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received on 08-dec-2017 and 08-jan-2018 (processed with clock start date of 08-dec- 2017).Global ptc number and ptc results were added.An additional event of device malfunction was added with details.Clinical course was updated and text was amended accordingly pharmacovigilance comment: sanofi company comment for follow up dated 08-dec-2017: this case concerns a patient who received synvisc one injection from the recalled lot and had infection for which patient had surgery.The concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the event 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
• MDR Report Key: 7156224
• MDR Text Key: 96111467
• Report Number: 2246315-2017-00284
• 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: 12/08/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/30/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 01/16/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR