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

Lot Number R1417

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Disability (2371); Test Result (2695)

Event Date 03/14/2015

Event Type  Injury  

Event Description

Based on additional information received on 29-april-2015, this case initially considered as non-serious was upgraded to serious as an event of functional disability with seriousness criteria of important medical event was added.This unsolicited device case from (b)(6) was received on (b)(6) 2015 from a physician (additional information was also received on (b)(6) 2015 and both information were processed together with clock start date (b)(6) 2015).This case involves a (b)(6) female patient who experienced functional disability, her synovial fluid white blood cells positive, synovial fluid red blood cells positive, edema in the joint of the left knee, effusion in the joint of the left knee and pain in the joint of the left knee after receiving treatment with synvisc one.The patient's medical history included allergy to antalgic non-steroidal anti-inflammatory drugs, hypothyroidism, fibromyalgia, bipolar disorder, surgery and degenerative arthritis.Past drugs included hyaluronic acid in the knees (chronology and the exact device used was uncertain because the information was not clearly reported).Relevant concomitant medications included levothyroxine sodium (levothyrox), lamotrigine (lamictal) and alimemazine tartrate (theralene).On (b)(6) 2015, for the third course, the patient received treatment with intra-articular (lateral external sus patella left knee joint) synvisc one injection, once (batch/ lot number: r1417; dose and expiry date: not reported) in the joint of the knees for degenerative arthritis.It was reported that the puncture of the joint had been performed before the injection and the needle used was intramuscular green.Synvisc one was at room temperature and no physical activity was performed after the injection.On next day ((b)(6) 2015), 1 day after initiating treatment with synvisc one, the patient experienced edema, effusion, pain associated with functional disability and pain in the joint of the left knee.On (b)(6) 2015, a puncture was performed in which 80 ml of liquid was removed and aspect yellow / inflammatory, white blood cell count was found to be 265/ml and red blood cell count was 187/ml (normal range: unknown for both).At the date of the last contact, the patient was not recovered.Corrective treatment: not reported for functional disability, synovial fluid white blood cells positive, synovial fluid red blood cells positive, none for edema in the joint of the left knee, pain in the joint of the left knee and puncture was performed for effusion in the joint of the left knee.Outcome: not recovered for functional disability, unknown for synovial fluid white blood cells positive, synovial fluid red blood cells positive, not recovered for edema in the joint of the left knee, effusion in the joint of the left knee and pain in the joint of the left knee.

Manufacturer Narrative

A pharmaceutical technical 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 would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: important medical event for functional disability.(b)(4).Additional information was received on 08-april-2015.Global ptc number with results was added and the text was amended accordingly.Additional information was received on 29-april-2015.This case initially considered as non-serious was upgraded to serious as an event of functional disability with seriousness criteria of important medical event was added.Patient's weight and height added.Medical history of the patient added.Lot number for suspect drug was added.Relevant concomitant medications added.Additional events of functional disability, synovial fluid white blood cells positive, synovial fluid red blood cells positive were added with details.Outcome for the events of edema in the joint of the left knee, effusion in the joint of the left knee and pain in the joint of the left knee was updated from recovering to not recovered.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 04-may-2015: in this case a (b)(6) female patient had functional disability after receiving synvisc one.Since the event started one day after receiving synvisc one so it could be assessed as one of the contributory factors for the event.Also, lack of detailed information regarding concomitant medications and concurrent disease precludes the complete case assessment.

• 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 ; 50 corporate drive; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4755796
• MDR Text Key: 5823647
• Report Number: 2246315-2015-40491
• 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: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: R1417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2015
• 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: THERALENE (CON.); HYALURONIC ACID (PREV.); LAMICTAL (CON.); LEVOTHYROX (CON.)
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 69