MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 13-dec-2019.This case involved a female patient who developed septic arthritis (confirmed by the synovial fluid examination without germ specification) after an unknown latency after intraarticular injection synvisc-one.Corrective treatment and outcome were not reported.The batch number was not reported for further investigations by the company.According to instructions for use rare cases of knee joint infection have been reported after synvisc injection, thus based on the limited information on this case the role of synvisc one on the occurrence of the reported infection cannot be excluded.However, one of the most common intraarticular procedure related complication is the joint infection/septic arthritis.The status of the knee before injection, the aseptic technique, the injection technique, the results of bacteriological tests of synovial fluid and the batch number are deemed necessary for further investigations by the company and for a proper assessment of this case.

Event Description

Analysed and found it was infected [joint infection] ([knee swelling], [knee effusion]).Case narrative: initial information received on 09-dec-2019 from (b)(6) regarding an unsolicited valid serious case received from a consumer (patient's husband).This case involves an unknown age female patient who received treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) in her knee and later it was analysed and found it was infected (latency: unknown).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.On (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate, frequency once (dose, indication, batch: unknown) (information for batch number was requested) by a physician.On an unknown date in 2019, after the injection, patients knee swelled and she was advised by her physician to get it drained.The patient had her knee drained and it was analysed and found it was infected (latency: unknown).This event was assessed as medically significant and the patient was hospitalized for same.Further, it was reported by the patients husband that the patient had been in the hospital for two and a half weeks.Action taken: not applicable.Corrective treatment: not reported.Outcome: unknown.A product technical complaint was initiated and results were pending for the same.

Event Description

Analysed and found it was infected [joint infection] ([knee swelling], [knee effusion]).Case narrative: initial information received on 09-dec-2019 from australia regarding an unsolicited valid serious case received from a consumer (patient's husband).This case involves an unknown age female patient who received treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one) in her knee and later it was analysed and found it was infected (latency: unknown).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.On (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate, frequency once (dose, indication, batch: unknown) (information for batch number was requested) by a physician.On an unknown date in 2019, after the injection, patients knee swelled and she was advised by her physician to get it drained.The patient had her knee drained and it was analysed and found it was infected (latency: unknown).This event was assessed as medically significant and the patient was hospitalized for same.Further, it was reported by the patients husband that the patient had been in the hospital for two and a half weeks.Action taken: not applicable.Corrective treatment: not reported.Outcome: unknown.A product technical complaint (ptc) was initiated on 27-feb-2020 for synvisc one (lot number unknown) 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 is identified and mitigated through the ncr process.Sanofi 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.Sanofi would continue to monitor adverse events to determine if a capa was required.Final investigation was completed on (b)(6) 2020.Additional information was received on 27-feb-2020 from other health professional.Ptc results received and processed.Global ptc number added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 9516723
• MDR Text Key: 187379154
• Report Number: 2246315-2019-00314
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention