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

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Pain (1994)

Event Date 06/01/2014

Event Type  Injury  

Event Description

Based on additional information received on (b)(6) 2014, this case was upgraded from non-serious to serious as the event of "tear in her left knee/ sore spots in left knee" was assessed as requiring intervention.This solicited device case received from (b)(6) on (b)(6)2014 from a patient via patient support program.Patient id: unknown; country: (b)(6) study title: patient support program involving synvisc one.The case involves a female patient (age not provided), who developed tear in her left knee/ sore spots in left knee and arthritis in left knee after receiving treatment with synvisc-one.Past medical history included meniscus repaired (approximately 2 years ago).Relevant past drugs, concomitant medications and concurrent conditions were not reported.On an unknown date in (b)(6)2014 (approximately on (b)(6)2014), the patient received treatment with synvisc­ one injection at a dose of 6 ml, once (route of administration, indication, batch/ lot number and expiry date: unknown) into left knee.On an unspecified date in (b)(6)2014 (a couple of weeks ago), patient had a scan on her left knee and the patient's physician advised her that there was still a tear in her left knee and she still had arthritis.The patient stated that she got some relief from synvisc-one and found that she could bend her left knee better.On an unknown date (approximately in (b)(6)2014), tear was repaired via an arthroscopy.Reportedly, the patient did have a few sore spots in the left knee.Later, patient also had tears in the right knee and patient had a repair (arthroscopy) in right knee (approximately in (b)(6)2014).Outcome: recovering: tear in her left knee/ sore spots in left knee and arthritis in left knee a pharmaceutical technical complaint (ptc) was initiated with global ptc number of (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.Data was periodically presented and reviewed by individuals responsible for assuring product safety.This review had not indicated any safety issue.Genzyme biosurgery would continue to monitor adverse events to determine if a capa would be required.No further information was provided.Consent to contact doctor for follow up was denied.Reporter's causality assessment: not reported company causality assessment: associated for both the events seriousness assessment: tear in her left knee/ sore spots in left knee (required intervention, underwent arthroscopy) additional information was received on (b)(6)2014.Ptc investigation report was added.Additional information was received on (b)(6)2014 from the patient.The case was upgraded from non-serious to serious as the event of "tear in her left knee/ sore spots in left knee" was assessed as requiring intervention (underwent arthroscopy).The event term was updated from tear in her left knee to "tear in her left knee/ sore spots in left knee".The outcome for events was updated from not yet recovered to recovering.Clinical course was updated and text was amended accordingly.

• Brand Name: SYNVISC ONE (SYNVISC ONE)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY; ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corp dr; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4369854
• MDR Text Key: 15315520
• Report Number: 2246315-2014-81207
• 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,Study,Consumer,Company Representative
• Type of Report: Initial
• Report Date: 06/18/2014

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/23/2014
• 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: CON MEDS = UNK; PREV MEDS = UNK