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

Device Problems Unexpected Therapeutic Results (1631); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Memory Loss/Impairment (1958); Concussion (2192); Dysphasia (2195); Brain Injury (2219)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on (b)(6) 2014 from a consumer (pt's husband).This case involves an (b)(6) female pt who couldn't get up/tried to get up, lost all control, had traumatic brain injury, fell and had concussion while receiving treatment with synvisc one.It was reported that synvisc one was injected in swollen knee (off label use).The pt had received four previous synvisc one injections in both the knees.No medical history or concomitant medication was reported.On (b)(6) 2014, the pt received treatment with synvisc one injection at a dose of 06 ml once (route, batch/lot number, expiration date; not provided) into both the knees (right knee was swollen prior to injection (off label use) for knee pain.The same day, following the injection, the pt could not get up, lost all control, tried to get up and fell.It was reported that the pt had to rush to the hospital.It was further reported that a magnetic resonance imaging (mri) was done and it did not know any bleeding.It was reported that the pt suffered a negative impact on the pt and she had to go to subacute nursing care for rehabilitation.It was further reported that the pt had aphasia and memory problems.It was also reported that the pt was very articulate before this happened and that the pt received speech pathology care and physical therapy.The pt was reported to be at home now, and doing better, but still not back to how she was before and was "so, so" now.It was reported that it was thought that no fluid was removed from the knee prior to injection.Corrective treatment: not reported for all the events.Outcome: not recovered/not resolved for couldn't get up/tried to get up, lost all control, traumatic brain injury and concussion.Seriousness criteria: hospitalization or prolongation for couldn't get up, lost all control, traumatic brain injury, fall and concussion.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.

Manufacturer Narrative

Pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: based on the info received, the role of synvisc one cannot be excluded for the events of could not get up/tried to get up and lost all control.However, the role of the device is unlikely for the event of fall, traumatic brain injury and concussion.The complete case assessment cannot be drawn due to lack of info regarding pts concomitant medications and concurrent conditions.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corporate dr; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4162732
• MDR Text Key: 18094351
• Report Number: 2246315-2014-36530
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CON MEDS = UNK; SYNVISC ONE (PREV.)
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR