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

Device Problem Inaccurate Delivery (2339)

Patient Problem No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Event Description

This spontaneous case from united states was received on 03-jan-2018 from the patient this case concerns a (b)(6) male patient who initiated treatment with synvisc one and after 1 day could not put a lot of weight on the left knee, barely could walk, had swelling and soreness/ pain/left knee still hurting; after unknown latency could not stand to take a shower and had to use a walker.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown date in 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once osteoarthritis left knee (batch/ lot number and expiry date: unknown).On an unknown date in 2017, the next day, his left knee experienced soreness swelling, pain, and he barely could walk.He said after the injection the physician told him to ice and elevate his left knee.He said he still could not put a lot of weight on the left knee (onset: 2017; latency: unknown).He said his knee was over half the size of his right knee.He said a couple of days later he contacted the physician about his pain.He said the physician wrote a prescription for pain medicine and it was tylenol 3.He said he was using a walker to get around and he said he was still using a walker (onset: 2017; latency: unknown).He said, as of (b)(6) 2018, his left knee was still hurting (onset: 2017; latency: unknown).Corrective treatment: ice, elevate for swelling; (paracetamol) tylenol, ice, elevate for soreness/ pain/left knee still hurting; not reported for others.Outcome: not recovered for all events.Seriousness criteria: disability for had to use a walker.A pharmaceutical technical complaint (ptc) was initiated and the result of the same was pending.Pharmacovigilance comment: sanofi company comment dated 09-jan-2018: this case concerns a male patient who received synvisc one injection for osteoarthritis left knee and was a walking aid user.Based upon the temporal gap, the causal role of the product cannot be denied with the occurrence of event.Further information regarding patient's current clinical presentation, technique of injection, concomitant medications and other risk factors would help in the complete medical assessment of the case.Also concurrent medical condition of osteoarthritis act as a confounder for the reported event.

Event Description

This spontaneous case from united states was received on 03-jan-2018 from the patient this case concerns a (b)(6) years old male patient who initiated treatment with synvisc one and after 1 day could not put a lot of weight on the left knee, barely could walk, had swelling and soreness/ pain/left knee still hurting; after unknown latency could not stand to take a shower and had to use a walker.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown date in 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once osteoarthritis left knee (batch/ lot number and expiry date: unknown).On an unknown date in 2017, the next day, his left knee experienced soreness swelling, pain, and he barely could walk.He said after the injection the physician told him to ice and elevate his left knee.He said he still could not put a lot of weight on the left knee (onset: 2017; latency: unknown).He said his knee was over half the size of his right knee.He said a couple of days later he contacted the physician about his pain.He said the physician wrote a prescription for pain medicine and it was tylenol 3.He said he was using a walker to get around and he said he was still using a walker (onset: 2017; latency: unknown).He said, as of (b)(6) 2018, his left knee was still hurting (onset: 2017; latency: unknown).Corrective treatment: ice, elevate for swelling; (paracetamol) tylenol, ice, elevate for soreness/ pain/left knee still hurting; not reported for others outcome: not recovered for all events seriousness criteria: disability for had to use a walker a pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4) and the result of the same was pending.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional follow up information was received on 23-jan-2018.Global ptc number was added.Additional information was received on 02-feb-2018.Ptc investigation results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 2-feb-2018: follow up received does not change previous case assessment.This case concerns a male patient who received synvisc one injection for osteoarthritis left knee and was a walking aid user.Based upon the temporal gap, the causal role of the product cannot be denied with the occurrence of event.Further information regarding patient's current clinical presentation, technique of injection, concomitant medications and other risk factors would help in the complete medical assessment of the case.Also concurrent medical condition of osteoarthritis act as a confounder for the reported event.

• 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: 7209195
• MDR Text Key: 97888532
• Report Number: 2246315-2018-00110
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

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?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 02/15/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 122