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

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Disability (2371); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/24/2014

Event Type  Injury  

Event Description

Based on additional information received on (b)(6) 2014, this case initially considered as non-serious upgraded to serious as the patient received intervention with cortisone for all the events.This unsolicited device case from united states was received on (b)(6) 2014, from a patient.Based on additional information received on (b)(6) 2014, the events of could not stand / could no longer support any weight and swelling in right knee were added.This case concerns a (b)(6) female patient who could not walk out of her office / difficult for her to walk / can barely walk it's been a month with a cane / needed a wheelchair to the car", whose muscles and tendons were tight, "could not bend her right knee / cannot climb stairs / could not straighten her right leg", "could not stand / could no longer support any weight" and swelling in right knee after receiving with synvisc one injection.No medical history and past drugs were reported.Concomitant medication included levothyroxine sodium (synthroid) for hypothyroid.On (b)(6) 2014, the patient received treatment with synvisc one injection at a dose of 6 ml, once (route, batch/lot number and expiration date: not provided) in both knees for mild arthritis (diagnosed on (b)(6) 2014, by x-rays).Immediately after the injection, the patient could not walk out of the office and could not walk.The patient needed chair to her car.It was reported that patient could not stand for three days.The patient's muscles and tendons were tight and she could not bend her right knee.It was reported that patient could not bend her knees for three weeks.It was reported that the left knee was fine and she was not having any pain in either of her knees.For two and half weeks, the patient could not straighten out her right leg.It was difficult for the patient to walk and could not climb stairs, she had pain in her right knee when she was stepping up.On the third week, the patient's right knee no longer supported any weight.The knee started swelling and patient could not straighten it.The patient had gait disturbance and could barely walk and reported that it had been a month with a cane.On (b)(6) 2014, patient had seen health professional in person.It was reported patient did not visit the emergency room.The patient reported that her life was great till she had synvisc one injection.The patient used to play racquetball three times a week, swam and did bicycle riding.Reportedly, 3 months after synvisc one injection patient still could not do anything.Corrective treatment: cortisone for the events of could not walk out of her office / difficult for her to walk / can barely walk it's been a month with a cane / needed a wheelchair to the car", whose muscles and tendons were tight, "could not bend her right knee / cannot climb stairs / could not straighten her right leg", "could not stand / could no longer support any weight" and naproxen and cortisone for the event of swelling in right knee.Outcome: unknown for muscles and tendons were tight and not yet recovered for the events of could not walk out of her office / difficult for her to walk / can barely walk it's been a month with a cane / needed a wheelchair to the car", "could not bend her right knee / cannot climb stairs / could not straighten her right leg", "could not stand / could no longer support any weight" and swelling in right knee.

Manufacturer Narrative

A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) and ptc results were pending.Seriousness assessment: required intervention for all the events.Additional information received on (b)(6) 2014, from the consumer.The case was upgraded to serious as the all the events required intervention with cortisone.The concomitant medication and concurrent conditions were reported.The start date of synvisc one was updated from (b)(6) 2014 to (b)(6) 2014 and indication of product synvisc one was updated from osteoarthritis to arthritis.The corrective treatment medication of cortisone was added.The events of could not stand / could no longer support any weight and swelling in right knee were added.The event term of event "could not walk out of her office / difficult for her to walk / can barely walk it's been a month with a cane" was updated to could not walk out of her office / difficult for her to walk / can barely walk it's been a month with a cane / needed a wheelchair to the car.The events of "could not walk out of her office / difficult for her to walk / can barely walk it's been a month with a cane / needed a wheelchair to the car", whose muscles and tendons were tight and could not bend her right knee / cannot climb stairs / could not straighten her right leg were upgraded to serious with seriousness criteria of required intervention and start date was added.The outcome of events "could not walk out of her office / difficult for her to walk / can barely walk it's been a month with a cane / needed a wheelchair to the car" and "could not bend her right knee / cannot climb stairs / could not straighten her right leg" was updated from unknown to not yet recovered.The patient's clinical course was updated and text was amended accordingly.Pharmacovigilance comment: (b)(4) company comment dated (b)(4) 2014: this case concerns a female patient who experienced the events of difficulty walking, musculoskeletal stiffness, joint range of motion decreased and weight bearing difficulty after receiving synvisc one injection.The causal relationship between the events and the products have been assessed as possibly related, however, the patient's underlying condition of arthritis could have played a contributor role in the causation of the events.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: michael murphy ; 55 corporate drive; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089813633
• MDR Report Key: 4004642
• MDR Text Key: 4958691
• Report Number: 2246315-2014-85457
• 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: Consumer
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 07/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PREV MEDS = UNK; SYNTHROID
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR