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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Cellulitis (1768)

Event Date 07/24/2015

Event Type  Injury  

Event Description

This unsolicited device case from (b)(6) was received on 13-aug-2015 from a health care professional.This case concerns a (b)(6) female patient who started treatment with synvisc and later developed right knee cellulitis.The patient's past drugs, medical history, concomitant medications and concurrent conditions were not reported.On (b)(6) 2015, the patient initiated treatment with intra-articular synvisc injection, at a dose of 2 ml, per week, into the joint (batch/lot number and expiration date: not provided) for replacement of synovial fluid.On (b)(6) 2015, 18 days after starting treatment with synvisc, the patient developed right knee cellulitis for which she needed an antibiotic treatment which consisted of oral ciprofloxacin hydrochloride (ciprofloxacin) at a dose of 500 mg 12 hourly, intramuscular gentamicin sulfate (gentamicin) at a dose of 160 mg per day, oral metronidazole (metronidazol) at a dose of 500 mg 8 hourly and subsequent abscess drainage by 10 days.It was reported that the patient had been doing well.Action taken: permanently discontinued outcome: recovering/ resolving a pharmaceutical technical complaint was initiated and results were pending for the same.Seriousness criteria: intervention required pharmacovigilance comment: sanofi company comment dated 17-aug-2015: this case concerns a (b)(6) female patient who received synvisc injection for synovial fluid replacement and developed right knee cellulitis.Evaluating the product and event onset dates, the plausible temporal relationship between the product and event cannot be denied.However, lack of detailed information about medical history, laboratory data, and concurrent medical illnesses, precludes a comprehensive assessment in this case.Moreover, the maintenance of aseptic conditions is mandatory during the injection of the product and any deviation from the same could provide a plausible explanation for the event.

Event Description

This unsolicited device case from ecuador was received on (b)(6) 2015 from a health care professional.This case concerns a (b)(6) years old female patient who started treatment with synvisc and later developed right knee cellulitis.The patient's past drugs, medical history, concomitant medications and concurrent conditions were not reported.On (b)(6) 2015, the patient initiated treatment with intra-articular synvisc injection, at a dose of 2 ml, per week, into the joint (batch/lot number and expiration date: not provided) for replacement of synovial fluid.On (b)(6) 2015, 18 days after starting treatment with synvisc, the patient developed right knee cellulitis for which she needed an antibiotic treatment which consisted of oral ciprofloxacin hydrochloride (ciprofloxacin) at a dose of 500 mg 12 hourly, intramuscular gentamicin sulfate (gentamicin) at a dose of 160 mg per day, oral metronidazole (metronidazol) at a dose of 500 mg 8 hourly and subsequent abscess drainage by 10 days.It was reported that the patient had been doing well.Action taken: permanently discontinued.Outcome: recovering/ resolving.A pharmaceutical technical complaint 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.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 adverse events to determine if a capa was required.Seriousness criteria: intervention required.Additional information was received on (b)(6) 2015.Global ptc number and results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated (b)(6) 2015: the follow up information does not change previous case assessment.Sanofi company comment dated (b)(6) 2015: this case concerns a (b)(6) year old female patient who received synvisc injection for synovial fluid replacement and developed right knee cellulitis.Evaluating the product and event onset dates, the plausible temporal relationship between the product and event cannot be denied.However, lack of detailed information about medical history, laboratory data, and concurrent medical illnesses, precludes a comprehensive assessment in this case.Moreover, the maintenance of aseptic conditions is mandatory during the injection of the product and any deviation from the same could provide a plausible explanation for the event.

• Brand Name: SYNVISC (SYNVISC)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5024289
• MDR Text Key: 23805506
• Report Number: 2246315-2015-98553
• 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
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR