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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Alteration In Body Temperature (2682)

Event Date 02/11/2015

Event Type  Injury  

Event Description

This unsolicited device case from (b)(6) was rec'd on (b)(6) 2015 and (b)(6) 2015 (both info processed together with clock start date of (b)(6) 2015) from physician (pt).This case involves a (b)(6) female pt who rec'd treatment with synvisc one and later whose "temp rose to 37.2 degree celsius" and experienced "bending knee became difficult", 'bearing weight on leg became difficult', warmth of the knee, "swelling of the knee/knee had been + 4 cm round", right knee became painful", her knee was aspirated, her left knee started to swell/still swollen/has now been clearly larger in size than the right knee and bearing weight on the left knee not possible.The pt medical history includes asthma, narcolepsy, posttraumatic stress disorder, organ problems (unspecified), atopic skin, allergic eye and nasal symptoms, dry eyes, and prolapse (unspecified) as primary diseases.It was reported that the pt has a lot of concomitant regular medications for her primary diseases, but she did not with to specify them.The regular medication had not changed for years and at lease ace-glucosamine/diethanolamine/sodium sulfate (arthryl) for arthrosis and tacrolimus cream.01 percent (nos) for rash were in use previously she had developed reactive inflammation of knee while jogging.She also reported her normal body temp being 36.5 degree celsius.On an unk date in (b)(6) 2014, the pt had rec'd synvisc one injection in both knees and on that occasion she had been extremely satisfied with the rec'd benefits.On (b)(6)2015, the pt again rec'd synvisc one injections.The pt was also reported being allergic to penicillin.On (b)(6) 2015, in the morning the pt initiated treatment with synvisc one 6 ml injection once (route, batch/lot no and expiry date was not provided) for arthrosis of both knees (into both the knees).The pt has not had any symptoms right after synvisc one was injected but after 2-3 hours, the pt developed warmth of the right knee and also her right knee became painful and bending was difficult.The knee started to swell until it was +4 cm (round) compared to the left one.At first, the pt did not have temperature.It was reported that the pt's knee was treated with a pack of ice cubes and took analgesic (unspecified).At 5 pm the pt was not able to bear weight on the leg anymore and driving home from work was also difficult sas she was not able to push the clutch.At home the pt took forearm crutches in use.On the same day, body temp had been 36.5 degree celsius between 2 and 3 pm, 37 degree celsius at 8 pm and 37.2 degree celsius at 9.30 pm (normal values were not provided).In the evening the pt had gone to hosp emergency room she was taken into inpatient care.At 11pm in the hosp 15 ml of thick synovial fluid were aspirated from the knee.Taking bacterial sample from the fluid was not possible.It was reported that the pt has not applied the tacrolimus cream on (b)(6) 2015.On (b)(6) 2015 at 1.30 am the pt initiated intravenous clindamycin phosphate (clindamycin) that was administered again at 6.15 am.On the same day, 25 ml of thinner looking synovial fluid was aspirated again from the knee.Synovial fluid sample was taken and the preliminary bacterial culture was negative.According to the treating surgeon, the event could not be a bacterial infection due to this.On (b)(6) 2015 the c - reactive protein had also decreased being below 10 mg/l (normal values were not provided) and leucocyte count was evaluated to approximately 8000 (nos) [ reference range 3.4-8.2 e9/l].It was also reported that warmth and temp were still present, and the knee was swollen, but the pt general condition had improved.On (b)(6) 2015 (in the evening), the pt was discharged home.It was reported that the knee was already a lot better and the pt used crutches on stairs but had no problems on walking on flat surface.On (b)(6) 2015, the pt's left knee has started to swell.On (b)(6) 2015, the pt had been at work.As of (b)(6) 2015, the pt's left knee was still swollen and had now been clearly larger in size than the right knee.No symptoms has appeared in this knee previously.The pt was currently not able to bear weight on the left knee and had an analgesic (nos) with the largest dose.On (b)(6)2015, the pt has a day off.It was reported that the pt would go to get fluid aspirated from the left knee in the beginning of the week if the knee got worse during the weekend.Further reported that the right knee has also been injected with cortisone (nos) and it was not in quite good condition.The final results from the bacterial culture were not yet rec'd but the preliminary identification had been negative as reported previously.The pt did not believe that she has bacterial infection in the left knee either.Outcome: not recovered/ not resolved for "temp rose to 37.2 degree celsius", left knee started to swell/still swollen/had now been clearly larger in size than the right knee, and bearing weight on the left knee not possible.Recovering for warmth of the knee, "swelling of the knee/knee has been + 4 cm round", "bending knee became difficult", "bearing weight on leg became difficult", right knee became painful and "knee was aspirated".

Manufacturer Narrative

(b)(4).The prod lot number was not provided; therefore, a batch record review was not possible.Based on the lack of info provided, no capa was required.It was the requirement to review all finished batch records for spec conformance prior to release.Any out of spec result was identified and mitigated through the ncr process.Data was periodically presented and reviewed by individuals responsible for assuring prod safety.This review has not indicated any safety issue.Genzyme biosurgery would continue to monitor adverse events to determine of capa was required.Seriousness criteria: hospitalization and required intervention for the events of "temp rose to 37.2 degree celsius", "bending knee became difficult", 'bearing weight on left became difficult', warmth of the knee, "swelling of the knee/knee had bed + 4 cm round, "right knee became painful" and her knee was aspirated.Add'l info was rec'd on (b)(4) 2015.The id no for the prod event (b)(4).Add'l info was rec'd on (b)(4) 2015 from the physician.It was confirmed that the preliminary bacterial culture has been negative and the event could not be a bacterial infection due to this.The lab tests were updated.The pt's discharge date was added.The pt's clinical course was updated.The outcome for the events of warmth of the knee, "swelling of the knee; knee had been + 4 cm round", "bending knee became difficult", "bearing weight on leg became difficult", right knee became painful and "knee was aspirated" was updated to recovering.The global ptc number was added.The text was amended accordingly.Add'l info was rec'd on (b)(4) 2015.Ptc results were added.Add'l events of the left knee started to swell/still swollen/ had now been clearly larger in size than the right knee and bearing weight on the left knee not possible with details were added.Corrective treatment of cortisone was added.Lab data of bacterial culture was added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow-up dated (b)(6) 2015: the follow-up info rec'd does not change the prior assessment of the case.Sanofi company comment for follow-up dated (b)(6) 2015: the follow-up info rec'd does not change the prior assesment of the case.Sanofi company comment dated (b)(6) 2015: this initial case concerns a (b)(6) female pt who developed the events of temp rose to 37.2 degree celsius; bending knee became difficult, baring weight on leg became difficult after receiving synvisc one for arthrosis of both knees.The pt's med history is significant for reactive inflammation of the knee joint that is indicative of the minimal causal role of the complaint device.Although the role of the device cannot be ruled out based on the drug event temporal relationship; however, lack of detailed info about medical history, lab data, any concurrent med illnesses, clinical course, etc.Of the pt precludes a comprehensive assessment of this case.Moreover, the results of the bacterial culture of the knee aspirate were still pending.Further, event clarification will be requested.

• 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 ; 55 corprate dr; mail stop: 55c-235a; bridgewater, NJ 08807-2397 ; 9089812784
• MDR Report Key: 4548768
• MDR Text Key: 19360376
• Report Number: 2246315-2015-18162
• 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: 02/11/2015

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: 02/11/2015
• Initial Date FDA Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNVISC ONE (PREV.); TACROLIMUS (CON.); ARTHRYL (CON.); PENICILLIN (PREV.)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR