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

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Muscular Rigidity (1968); Pain (1994); Swelling (2091); Disability (2371)

Event Date 04/17/2014

Event Type  Injury  

Event Description

Based on additional information received on (b)(6) 2014, this case initially considered as non-serious was upgraded to serious as the patient received treatment with methylprednisolone (medrol dose pack) for the events of knee effusion (cloudy milky appearance) and pain in one knee (intervention required).This unsolicited device case was received from united states on (b)(6) 2014 from physician's assistant.Based on additional information received on (b)(6) 2014, the events of knee effusion (cloudy milky appearance) and inability to function and work were added.This case concerns a (b)(6) year old male patient who experienced stiffness, knee effusion (cloudy milky appearance), pain in one knee and developed inability to function and work after receiving synvisc injection.The patient's medical history was significant for hypertension, asthma and sleep apnea.No relevant past drugs and concurrent conditions were provided.Concomitant medications included fluticasone propionate (flonase) and amlodipine.On (b)(6) 2014, the patient received treatment with synvisc injection, once (route, dosage regimen, batch/lot and expiration date unknown) in both knees for an unknown indication.On (b)(6) 2014, a day after the first injection, the patient experienced stiffness and pain in one knee.The patient also developed increased knee effusion and inability to function and work.The patient received treatment with methylprednisolone (medrol dose pack) for the events of pain in one knee and knee effusion and took two days off from work.On (b)(6) 2014, the patient underwent arthrocentesis and 30 cc of cloudy milky joint fluid was aspirated from one knee and 50 cc of cloudy milky joint fluid was aspirated from other knee.Action taken: permanently discontinued.Corrective treatment: unknown for the events of stiffness and inability to function and work.Outcome: recovered/resolved for the events of knee effusion (cloudy milky appearance), pain in one knee and inability to function and work and unknown for the event of stiffness in one knee.

Manufacturer Narrative

A pharmaceutical technical complaint (ptc) was initiated with a global ptc number: (b)(4).The product lot number was not provided therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Data is periodically presented and reviewed by individuals responsible for assuring product safety.This review has not indicated any safety issue.Genzyme biosurgery will continue to monitor adverse events to determine if a capa is required.Reporter causality: related to the events of knee effusion (cloudy milky appearance) and pain in one knee and not provided for the rest of the events.Seriousness criteria: intervention required for the events of knee effusion (cloudy milky appearance) and pain in one knee.Additional information was received on (b)(6) 2014.The ptc results were added.Additional information was received on (b)(6) 2014.The patient's age was updated to (b)(6) years.The events of inability to function and work and knee effusion (cloudy milky appearance} were added.The case was upgraded to serious as the patient received treatment with methylprednisolone (medrol dose pack) for the events of knee effusion (cloudy milky appearance) and pain in one knee.The patient's medical history and concomitant drugs were updated.The action taken was updated from unknown to permanently discontinued.The corrective treatment for the event of pain in one knee was added.The outcome for the event of pain in one knee was updated from unknown to recovered.Reporter causality was added for the events of knee effusion (cloudy milky appearance) and pain in one knee.Clinical course was updated.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: michael murphy ; 55 corporate dr; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089813633
• MDR Report Key: 3890824
• MDR Text Key: 4653474
• Report Number: 2246315-2014-52529
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 06/04/2014
• 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: FLONASE (CON.); PREV MEDS = UNK; AMLODIPINE (CON.)
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR