MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC; MOZ

Lot Number 7RSP019Z

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); Joint Swelling (2356); Disability (2371)

Event Type  Injury  

Event Description

Immobile [immobile], pain and swelling in both knees [knee pain], pain and swelling in both knees [knee swelling].Case narrative: upon internal review on 18-may-2018, the product was updated to synvisc from synvisc one.This unsolicited case from united states was received on 14-may-2018 from a nurse.This case concerns a (b)(6) female patient who received treatment with synvisc injection and was immobile (latency: unknown), pain and swelling in both knees (after few days).The patient had a history of problems after the second injection in a past series of three.No medical history, concomitant medication and concurrent conditions were reported.On an unknown date in (b)(6) 2018, patient received treatment with intra- articular synvisc injection in both knees (dose, frequency: unknown) (lot number: 7rsp019z; expiry date: 30-sep-2020 and lot number: 7rsp015; expiry date: 30-sep-2020) for osteoarthritis.On same day, few days after receiving the synvisc injection, patient experienced pain and swelling in both knees after the second injection in the series of three.This caused the patient to become immobile (onset date: unknown; latency: unknown).The physician prescribed pain medication.The incident was said to have occurred last week.The patient's mobility was said to have improved.The patient was not planned to have the final injection in the series.Action taken: unknown.Corrective treatment: pain medication for pain in both knees; not reported for rest of the events.Outcome: unknown for all the events.Investigation summary for lot number - 7rsp019z.A product technical complaint (ptc) was initiated on 18-may-2018 for synvisc; batch number 7rsp019z; (b)(4).The production and quality control documentation for lot 7rsp019z expiration date (2020-09-30) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot batch record review & lot frequency analysis for lot 7rsp019z no capa was required.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.As of 18-may-2018 there was only 1 complaint on file for lot 7rsp019z: (1) adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.Investigation summary for lot number - 7rsp015 a product technical complaint (ptc) was initiated on 18-may-2018 for "synvisc".Batch number 7rsp015, (b)(4).The reporter stated that the device caused "pain and swelling in both knees and was immobile" that resulted in "arthralgia, joint swelling and immobile".The production and quality control documentation for lot 7rsp015 expiration date (2020-09-30).The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot batch record review and lot frequency analysis for lot 7rsp015 no capa was required.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 18-may-2018.As of 18-may-2018, there were total 9 complaints on file for lot 7rsp015 and all related sublots.One complaint was on file for lot 7rsp015a and other 8 complaints were for lot 7rsp015.No safety issues were indicated in this review.Seriousness criteria: disability for immobile.Additional information was received on 18-may-2018.Global ptc number and results were added.Text was amended accordingly.Additional information received on 18-may-2018.Gptc number was added and results were added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7854716
• MDR Text Key: 119504271
• Report Number: 2246315-2018-00567
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Lot Number: 7RSP019Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 76 YR