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

Lot Number S1301

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Therapeutic Response, Decreased (2271); Disability (2371); Reaction (2414); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Based on additional information received on (b)(4) 2014, this case initially considered as non-serious was upgraded to serious (intervention required for the events).This unsolicited device case from united states was received on (b)(4) 2014 from the healthcare professional (hcp).Based on additional information received on (b)(4) 2014, the events of limited range of motion, limited mobility and knee swelling were added.This case concerns a (b)(6) year old female patient who developed pseudoseptic reaction, limited range of motion, limited mobility, knee swelling and "still had pain" after receiving treatment with synvisc one.The patient had a concurrent condition of lyme disease (could not be treated with corticosteroids).Concomitant medication included losartan potassium (losartan) for hypertension.The patient had no known drug allergies.No past drug and medical history was reported.On (b)(6) 2014, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml, once, batch/lot number: s1301 and expiration date: apr-2016, into both knees for bilateral knee osteoarthritis.On an unspecified date in (b)(6)2014, a couple of days after the administration of synvisc one, the patient developed a pseudoseptic reaction.On (b)(6) 2014, four days after the synvisc one injection, the patient experienced limited range of motion, limited mobility and knee swelling.On (b)(6) 2014, the patient was seen in the hcp's office complaining of knee pain.The same day, both knees were aspirated for 40-50 cc of synovial fluid.It was reported that the synovial fluid cultures were negative for infection.On (b)(6) 2014, the patient again went to the hcp's office and reported that she still had pain (subtherapeutic response) on ambulation.On (b)(6) 2014, the patient recovered from the events of limited range of motion, limited mobility and knee swelling.It was reported that the patient's concurrent condition lyme disease might have played a role in the patient's events.Corrective treatment: methylprednisolone acetate (depo-medrol) and bupivacaine (marcaine) for the events of pseudoseptic reaction, limited range of motion, limited mobility and knee swelling.Outcome: recovered/ resolved for the events of limited range of motion, limited mobility and knee swelling, unk for the events of pseudoseptic reaction and still had pain (subtherapeutic response).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 is required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated throughout ncr process.Data was periodically presented and review by individuals responsible for assuring product quality.This review had not indicated trends that could be associated with any product complaint.Genzyme will continue to monitor complaints to determine if a capa was required.Seriousness criteria: intervention required for the events of pseudoseptic reaction, limited range of motion, limited mobility and knee swelling.

Manufacturer Narrative

Additional information was received on (b)(4) 2014.Ptc investigation results were added.Additional information was received on (b)(4) 2014 from the healthcare professional.The case initially considered as non-serious was upgraded to serious (intervention required for the events).Patient's details including date of birth, age and height was added.Concomitant medication, concurrent condition and allergy history was added.The route, batch/lot number, expiration date and indication for synvisc one was added.The events of limited range of motion, limited mobility and knee swelling were added.Treatment medications were added.Clinical course was updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: this case concerns a patient who experienced pseudoseptic reaction, limited range of motion and mobility while receiving treatment with synvisc one.In this case, the causal role of synvisc one cannot be excluded for the occurrence of the events.

• Brand Name: SYNVISC ONE
• 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: 3834656
• MDR Text Key: 4401028
• Report Number: 2246315-2014-12791
• 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: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Lot Number: S1301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2014
• 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: LOSARTAN (CON.) UNK - ON GOING; PREV MEDS = UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR