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

Lot Number V1212A1

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Alteration In Body Temperature (2682); Fluid Discharge (2686); Test Result (2695)

Event Date 04/30/2015

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on (b)(6) 2015 (additional information received on (b)(6)2015, both the information processed together with clock start date as (b)(6) 2015) from a physician's assistant.This case has been cross referred with cases (b)(6) (cluster).This case concerns a (b)(6) male patient who experienced swollen hot painful knee/extremely swollen knee and excess fluid in the knee after receiving treatment with synvisc one.No medical history, other concomitant medications and concurrent conditions were reported.On (b)(6) 2015, the patient received treatment with intra-articular synvisc one injection, at a dose of 6ml once (lot/batch number: v1212a1 and expiration: aug 2015) for knee osteoarthritis and knee pain.On (b)(6) 2015, 3 days after the synvisc one injection, the patient experienced swollen, hot and painful knees.It was reported that the patient did not have fever or signs of sepsis.On an unknown date, excess fluid was removed from the knee.Corrective treatment: oral steroids, intramuscular ketorolac tromethamine (toradol) and non-steroidal anti-inflammatory drugs nsaids.Outcome: recovered/resolved for the event of swollen hot painful knee/extremely swollen knee and unknown for the event of excess fluid in the knee.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: required intervention (oral steroids) for the events of swollen hot painful knee/extremely swollen knee.

Manufacturer Narrative

A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).The production and quality control documentation for lot # v1212a1, with expiration date (08/2015) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # v1212a1, no capa was required.Genzyme global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Genzyme biosurgery would continue to monitor complaints to determine if a capa was required.Seriousness criteria: required intervention (oral steroids) for the events of swollen hot painful knee/extremely swollen knee.Reporter's causality: associated for the events of swollen hot painful knee/extremely swollen knee; not reported for the event of excess fluid in the knee.Company causality: associated for all the events.Additional information was received on july 9, 2015.Global ptc number and results were added.Text was amended accordingly.

Manufacturer Narrative

Reporter's causality: associated for the events of swollen hot painful knee/extremely swollen knee; not reported for the event of excess fluid in the knee.Company causality: associated for all the events.

Event Description

Upon internal review on july 9, 2015, the case type initially processed as unsolicited was corrected to a solicited case.Study title: unsponsored study involving synvisc one.This case concerns a (b)(6) male patient who experienced swollen hot painful knee/extremely swollen knee and excess fluid in the knee after receiving treatment with synvisc one.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ 07657 2397
• Manufacturer Contact: kristen sharma, md ; 9089812784
• MDR Report Key: 4908216
• MDR Text Key: 22163903
• Report Number: 2246315-2015-97412
• 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: Health Professional,health professional,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/01/2015
• Device Lot Number: V1212A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2015
• 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: PREV MEDS = UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 97