MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 4RSD004A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Swelling (2091); Ambulation Difficulties (2544); Alteration In Body Temperature (2682); Fluid Discharge (2686)

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on (b)(6) 2015 from a healthcare professional (other).This case was cross with cases: (b)(4) (cluster cases).This case concerns a (b)(6) female pt who developed red knee, was unable to bear weight on the knee, had large knee, hot knee and knee was aspirated while receiving treatment with synvisc.The pt had received several series of synvisc in the past.No medical history, concomitant medication or concurrent condition was reported.On an unk date, the pt initiated treatment with intra-articular synvisc injection at a dose of 2 ml (frequency and expiration date: not provided; batch/lot number 4rsd004a) for osteoarthritis.On an unk date, following the third injection, the pt experienced "large red hot knee".It was reported that the pt was unable to bear weight on the knee.On unk dates, the knee was aspirated and a cortisone injection was given.It was reported that the lab cultures were negative.Corrective treatment: cortisone for all the events.Outcome: unk for all the events.A pharmaceutical complaint (ptc) was initiated and ptc results were pending.Seriousness criteria: required intervention for all the events.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2015: this case concerns a (b)(6) female pt who was unable to bear weight on the knee after receiving synvisc injection for osteoarthritis.Since the pt experienced the event after receiving the injection therefore temporal relationship between synvisc and the event cannot be excluded completely and causal role of synvisc in occurrence of the event cannot be denied completely.However, due to lack of the complete clinical presentation, the patient's underlying concurrent medical conditions and concomitant medications the complete medical assessment is difficult.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME CORPORATION; 1125 pleasantview terrace; ridgefield NJ 07657 239
• Manufacturer Contact: kristen sharma, md ; 55 corporate dr; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4837688
• MDR Text Key: 15907159
• Report Number: 2246315-2015-79678
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

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: Health Professional
• Device Lot Number: 4RSD004A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNVISC (PREV.); CON MEDS
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR