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

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

This unsolicited device case from (b)(6) was received on (b)(6) 2016 from the physician.This case concerns a female patient of unknown age who received treatment with synvisc one on an unknown date and developed septic arthritis.The medical history was significant for bilateral knee osteoarthrosis (several years of evolution).No past drugs, concomitant medications and concurrent conditions were reported.On an unknown date, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number and expiration date: not provided) on an unspecified knee for palliative treatment for osteoarthrosis.On an unspecified date, after an unknown latency, the patient developed septic arthritis on the infiltrated knee after the injection.Corrective treatment: not reported outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: important medical event.Pharmacovigilance comment: sanofi company comment dated 11-mar-2016: this case concerns a patient who received injection of synvisc one in an unspecified knee and experienced septic arthritis.Although the causal role of the product in the occurrence of the event have not been denied, however, since there is no information regarding the conditions under which the patient received the injection and the technique of injection a complete medical assessment is difficult.Furthermore, the details of the underlying condition of osteoarthritis are also not available.Hence, further information regarding the injection technique including other co-morbidities is required to make complete case assessment.

Event Description

This unsolicited device case from (b)(6) was received on 07-mar-2016 from the physician.This case concerns a female patient of unknown age who received treatment with synvisc one on an unknown date and developed septic arthritis.The medical history was significant for bilateral knee osteoarthrosis (several years of evolution).No past drugs, concomitant medications and concurrent conditions were reported.On an unknown date, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number and expiration date: not provided) on an unspecified knee for palliative treatment for osteoarthrosis.On an unspecified date, after an unknown latency, the patient developed septic arthritis on the infiltrated knee after the injection.Corrective treatment: not reported.Outcome: unknown.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.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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: important medical event.Additional information was received on 15-mar-2016.Global ptc number with results was added and the text was amended accordingly.Pharmacovigilance comment: (b)(4) follow up company comment dated 15-mar-2016: the follow up information received does not change previous case assessment.(b)(4) comment dated 11-mar-2016: this case concerns a patient who received injection of synvisc one in an unspecified knee and experienced septic arthritis.Although the causal role of the product in the occurrence of the event have not been denied, however, since there is no information regarding the conditions under which the patient received the injection and the technique of injection a complete medical assessment is difficult.Furthermore, the details of the underlying condition of osteoarthritis are also not available.Hence, further information regarding the injection technique including other co-morbidities is required to make complete case assessment.

• Brand Name: SYNVISC ONE (SYNVISC ONE)
• 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: 5500393
• MDR Text Key: 40323966
• Report Number: 2246315-2016-00046
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other