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

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

Patient Problems Lupus (1956); Confusion/ Disorientation (2553)

Event Date 08/21/2015

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on 26-apr-2016 from a patient via health authority of united states (usa-fda with regulatory reference number: mw5060798).This case concerns a male patient of unknown age who felt disoriented and severe reaction probably triggered lupus while receiving treatment with synvisc.The patient fell and broke his right knee cap and tore up left knee.The right knee cap was wired up together.After 1.5 years, knees were still really stiff and sore.The concomitant medication was centrum silver vitamins.No past drug or concurrent condition was reported.On an unknown date in (b)(6) 2015, the patient initiated treatment with intra-articular synvisc injection (dose, frequency, indication, batch/ lot number and expiration date: not provided) into right knee.On an unknown date in (b)(6) 2015, a couple of weeks later, the patient received the injection in left knee.On (b)(6) 2015, a couple of days after the second injection, the patient's whole body swelled up and the patient could hardly lift his right arm and was disoriented.By the time the patient got to the orthopaedic surgeon, he took one look at him and told him that he needed to see a doctor.It was reported that it got so bad that his wife had to call 911.It was further reported that the patient ended up in the hospital for 12 days.The patient was told that the severe reaction had probably triggered lupus.The patient had to take 2 prescriptions and sometimes used a walker.Action taken: unknown.Corrective treatment: 2 unspecified prescriptions for both the events and walker for disoriented.Outcome: unknown for both the events.(b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored 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 had not indicated any safety issue.Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: hospitalization or prolongation for both the events additional information was received on 12-may-2016.The ptc results were added and text was amended accordingly.Pharmacovigilance comment: sanofi follow up company comment dated 12-may-2016: follow up information received does not change the previous case assessment.Sanofi company comment dated 5-may-2016: this case concerns a patient who received synvisc injections and later was hospitalized for severe reaction that triggered lupus with whole body swelling and disorientation.Based upon the clinical course of the patient it is likely that the product played a role in the causation of the events.However, further information regarding the medical history, underlying condition, concomitant medications and other risk factors precludes the complete case assessment.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5723273
• MDR Text Key: 47337726
• Report Number: 2246315-2016-00071
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• 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
• Treatment: CENTRUM(CON.)-START-UNKNOWN
• Patient Outcome(s): Hospitalization