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

Lot Number Q14051

Device Problem Difficult to Insert (1316)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 01/10/2015

Event Type  Injury  

Event Description

This solicited device case from (b)(6) was received on (b)(6) 2015 from a patient via patient support program (on track with synvisc).Study title: (b)(6).This case involves a (b)(6) female patient who received treatment with synvisc and complained that the injection was too thick and painful; she was in pain (sub-therapeutic response) and was limping.The patient's medical history, past drugs, concurrent conditions and concomitant medications were not reported.On (b)(6) 2015, the patient received intra-articular synvisc injection, at a dose of 2 ml once, in right knee (lot number: q14051 and expiration date: not provided) for osteoarthritis.The same day, the patient stated that she was in pain and that the synvisc injection was too thick and painful.On (b)(6) 2015, one day after receiving treatment with synvisc, patient starting limping.It was reported that the patient took paracetamol ((b)(6)) from time to time.Patient was also prescribed (b)(6) but patient tried to stick to paracetamol because (b)(6) 3 used to make her constipated.The patient was limping for four months, every day until she got another injection called triamcinolone acetonide (kenalog) in may.It was reported that the patient recovered after this injection.Action taken: permanently discontinued.Corrective treatment: triamcinolone acetonide for limping, paracetamol for she was in pain and injection was too thick and painful.Outcome: recovered/resolved for limping and injection was too think and painful.

Manufacturer Narrative

A pharmaceutical technical complaint was initiated and results were pending for the same.Reporter causality assessment: not reported for all events.Company causality assessment: associated for limping and injection was too thick and painful; not associated for she was in pain.Serious criteria: required intervention for limping.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2015: this case concerns a patient who received synvisc for osteoarthritis in knee.Patient experienced limping after the administration of synvisc injection.Based on the information received and evaluating the plausible event-temporal relationship the role of synvisc cannot be completely ruled out in the causation of event.However, lack of detailed information about medical history, lab data, any concurrent medical illnesses, clinical course etc of the patient precludes a comprehensive assessment in this case.The event might be due to the underlying osteoarthritis, injection site pain or may be due to wrong technique of giving the injection.The clear causal association cannot be established.

• 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 corporate drive; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4873925
• MDR Text Key: 5866177
• Report Number: 2246315-2015-89726
• 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,Study,Consumer
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: Q14051
• Date Manufacturer Received: 06/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PREV MEDS = UNKNOWN; CON MEDS = UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR