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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Arthritis (1723); Swelling (2091)

Event Date 11/25/2014

Event Type  Injury  

Event Description

Based on additional information received on (b)(6) 2014, this case initially assessed as non-serious was upgraded to serious as the event of arthritis not otherwise specified/injection site pseudo inflammatory reaction of arthritis type and newly added event of injection sites effusion were assessed as important medical events.This unsolicited device case was received from (b)(6) on (b)(6) 2014 from a physician.This case involves a male patient (age not provided) who experienced arthritis not otherwise specified/injection site pseudo inflammatory resection of arthritis type and injection site effusion after receiving treatment with synvisc one.No relevant medical history, concomitants, past drugs or concurrent conditions was reported.On an unknown date in (b)(6) 2014, the patient received treatment with intra-articular synvisc one injection once (dose, batch/lot number, expiry date and indication: unknown) into the joint of the knee.It was the first injection.On (b)(6) 2014, the patient presented with a pseudo-inflammatory reaction of the arthritis type not otherwise specified in the same knee which was associated with injection site effusion.Further reported, the patient received a corrective treatment with ibuprofen (ibuprofen) and 3 days later, the patient had recovered.Action taken: permanently discontinued.Outcome: recovered for both the events.A pharmaceutical complaint (ptc) was initiated with global ptc number: (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 will continue to monitor adverse events to determine if a capa was required.Imputability: (b)(4) for both the events.Seriousness criteria: important medical event for both the events.Additional information was received on (b)(6) 2014.However, all the information was processed with clock start date of (b)(6) 2014.The patient's gender was added.The event verbatim of arthritis not otherwise specified was updated to arthritis not otherwise specified/injection site pseudo inflammatory reaction of arthritis type and its outcome was also updated from recovering to recovered.The additional event of injection site effusion with details was added.The product start date with its frequency was added.The action taken was updated from unknown to permanently discontinued.(b)(4) imputability was updated.Global ptc number was added.Clinical course updated and the text was amended accordingly.Additional information was received on (b)(6) 2014.Ptc results were added and the text was amended accordingly.

• Brand Name: SYNVISC ONE (SYNVISC ONE)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corporate drive; mail stop: 55c-235a; bridewater, NJ 08807 ; 9089812784
• MDR Report Key: 4359714
• MDR Text Key: 5235542
• Report Number: 2246315-2014-69053
• 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
• Type of Report: Initial
• Report Date: 12/02/2014

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: 12/05/2014
• Initial Date FDA Received: 12/17/2014
• 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
• Patient Outcome(s): Other