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

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Pain (1994); Vomiting (2144); Joint Swelling (2356); Disability (2371); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Based on the add'l info rec'd on (b)(4) 2014, this case initially considered as non-serious was upgraded to serious as the pt experienced disabling events of "difficulty in walking/ dragging of knee", "unable to drive and daily normal activities" and "swelling in left knee." this unsolicited device case was rec'd from (b)(4) on (b)(6) 2014 from rheumatologist via sales rep.Based on the add'l info rec'd on (b)(4) 2014 from a physiotherapist, the events of vomiting, stomach ache, difficulty in walking/ dragging of knee, unable to drive and daily normal activities and swelling in left knee were added.This case involves an adult female pt (age not provided) who experienced increase in pain, vomiting, stomach aches, difficulty walking/ dragging of knee, unable to drive and daily normal activities and swelling in left knee after receiving synvisc one injection.The pt's medical history, past drugs and concomitant conditions were not reported.Pt had concurrent condition of pain.On (b)(6) 2013, the pt rec'd treatment with intra-articular synvisc one injection, at a dose of 06 ml, once (batch/lot number and expiration date not provided) into unspecified knee for knee osteoarthritis.The same day, the pt underwent episodes of vomiting, stomach ache post injection along with considerable swelling in the left knee.However, on (b)(6) 2013, after 3 days, the pt recovered from the event of vomiting.It was reported that swelling was removed for a period of one month.On an unk date, the pt experienced difficulty in walking resulting in dragging of knee because of which she was unable to drive and perform daily normal activities.Corrective treatment: domperidone for the event of swelling in left knee.Outcome: recovered/ resolved for the event of vomiting.Not recovered/ not resolved for the events of difficulty in walking/ dragging of knee, unable to drive and daily normal activities, swelling in left knee and stomach ache.Unk for the event of increase in pain.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) and conclusion was pending for the same.Seriousness criteria: significant disability/ incapacity for the events of "difficulty in walking/ dragging of knee", "unable to drive and daily normal activities" and "swelling in left knee." rptr's causality: probable for swelling of left knee, difficulty in walking/dragging of knee, unable to drive and daily normal activities.Add'l info was rec'd on (b)(4) 2014 from a physiotherapist.The therapy details for synvisc one injection (start date, route of administration, dosage regime and indication) were updated.The treatment medication of domperidone was added.The events of vomiting, stomach ache, difficulty in walking/ dragging of knee, unable to drive and daily normal activities and swelling in left knee were added.Subsequently, the pt's clinical course was amended accordingly.

Manufacturer Narrative

(b)(4): in this f/u the case was upgrade to serious.The pt was treated with synvisc-one for an indication of knee osteoarthritis.The causal role of synvisc-one cannot be excluded for the occurrence of the events of difficulty in walking/dragging of knee, unable to drive and daily normal activities; however, the role of underlying disease in causation of the events cannot be underestimated either.

• Brand Name: SYNVISC ONE (SYNVISC ONE)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: 55 corporate drive; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089816698
• MDR Report Key: 3676779
• MDR Text Key: 4244352
• Report Number: 2246315-2014-17564
• 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,Company Representative
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 02/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CON MEDS =UNK; PREV MEDS =UNK
• Patient Outcome(s): Disability