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

Lot Number Q1311A1

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Synovitis (2094); Reaction, Injection Site (2442); Test Result (2695)

Event Date 05/07/2015

Event Type  Injury  

Manufacturer Narrative

Outcome: recovered for all the events (date: unspecified).A pharmaceutical technical complaint (ptc) was initiated with global ptc number: 37923.The production and quality control documentation for lot # q1311a1, with expiration date (03/2016) was reviewed.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 # q1311a1, no capa was required.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Genzyme biosurgery would continue to monitor complaints to determine if a capa was required.Seriousness criteria: required intervention for all the events.French imputability: c3s2b3 for all the events.Additional information was received on 05/29/2015 for the physician.The event onset data of the events of "mild injection site inflammatory reactions" and injection site puncture were performed/ 150 ml of synovial liquid were removed from right knee/ 90 ml from left knee" was updated from (b)(6) 2015.Clinical course updated and text was amended accordingly.Additional information was received on 07/07/2015.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on 07/27/2015 from the physician.This case initially considered as non-serious was upgraded to serious as a serious event of synovitis (required intervention) was added with details.The event term of "injection site puncture were performed/ 150 ml of synovial liquid were removed from right knee/ 90 ml from left knee" was updated to injection site puncture were performed / 150 ml of synovial liquid were removed from right knee/ 90 ml from left knee/ recurrent injection site puncture" and "mild injection site inflammatory reactions" was updated to "recurrent mild injection site inflammatory reactions".Patient's medical history was updated.Product start date of synvisc was added.Lot number and indication of synvisc was added.Corrective treatment (prednisolone, desloratadine and hydroxyzine) was added.Laboratory test were added.Action taken was updated from stopped temporarily to permanently discontinued.Outcome of the events was updated from unknown to recovered.French imputability was updated from c2s2b3 to c3s2b3 for all the events.Seriousness criterion for the events of recurrent mild injection site inflammatory reactions and injection site puncture were performed/ 150 ml of synovial liquid were removed from right knee/ 90 ml from left knee/ recurrent injection site puncture was added.Clinical course was updated and text was amended accordingly.Additional information was received on 07/29/2015.The ptc results with lot number were added and text amended accordingly.

Event Description

Based upon the additional information received on 07/27/2015, this case initially considered as non-serious was upgraded to serious as a serious event of synovitis (required intervention) was added and previously assessed non-serious events (recurrent mild injection site inflammatory reactions and injection site puncture were performed / 150 ml of synovial liquid were removed from right knee / 90 ml from left knee / recurrent injection site puncture) were upgraded to serious (required intervention).Upon internal review, the initial clock start date was updated on (b)(6) 2015.This unsolicited device case from (b)(6) was received on 05/29/2015 from a physician.This case concerns a (b)(6) female patient who initiated treatment with synvisc and experienced synovitis, recurrent mild injection site inflammatory reactions and injection site puncture were performed/ 150 ml of synovial liquid were removed from right knee/ 90 ml from left knee/ recurrent injection site puncture.In 2012, the patient had received a first course of synvisc injections.No information regarding tolerance during this first course was reported.Patient's medical history included grade ii and iii chondropathy (lateral femorotibial right and left knee).No concomitant medications or concurrent conditions were reported.On (b)(6) 2015, the patient initiated treatment with bilateral intra-articular synvisc injection, once (second course) (dose, expiration date: not provided, batch/lot number: (b)(4)) in the joints of the knees for degenerative osteoarthritis.The same day, the patient was diagnosed with mild synovitis with inflammatory reaction effusion.On an unspecified date in (b)(6) 2015, the patient presented with mild injection sites inflammatory reactions.After the second session of injections, the reactions were increased.The same day, injection sites were performed: 150 ml of synovial liquid were removed from the right knee, 90 ml from the left knee.No signs of infection were found out.On (b)(6) 2015, patient again received synvisc injection.On an unspecified date in (b)(6) 2015, patient experienced injection site inflammatory reactions, injection site punctures and synovitis.On (b)(6) 2015, puncture was performed and showed sallow inflammatory appearance.Biological tests showed c reactive protein (crp) at 18, leukocytes at 7500 (units not provided), procalcitonin: less than 0.05 ng/ml (normal range: not provided for all).Fluid analysis showed leukocytes at 3555/mm3 sterile (right knee) and leukocytes at 6525/mm3 sterile (left knee).It was reported that synvisc was interrupted after second injection and was withdrawn for the future.Action taken: permanently discontinued.Corrective treatment: prednisolone (solupred), desloratadine (aerius), hydroxyzine (atarax) and drainage for all the events.

• Brand Name: SYNVISC (SYNVISC)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corp. drive; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5829854
• MDR Text Key: 54271164
• Report Number: 2246315-2015-98543
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 05/29/2015

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
• Device Expiration Date: 03/01/2016
• Device Lot Number: Q1311A1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2015
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 55