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

Lot Number UNKNOWN

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

Patient Problems Bacterial Infection (1735); Cellulitis (1768); No Code Available (3191)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 11-dec-2020: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate and experienced septic arthritis and cellulitis.Since the temporal relationship was unknown and the nature of the events suggest role of the suspect, therefore, the causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s current medical condition, concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Septic arthritis [septic arthritis].Cellulitis [cellulitis].Case narrative: initial information received on 08-dec-2020 regarding a solicited valid serious case received from a physician, in the scope of market research program "mrs_20-2318".Patient id: (b)(6); country: (b)(6).Study title: ostheo psp evaluation.This case involves a (b)(6) male patient who experienced septic arthritis and cellulitis, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (unknown dose, frequency, route, batch/lot number) for unknown indication.On an unknown date in (b)(6) 2015, after an unknown latency.The patient experienced moderate septic arthritis (arthritis bacterial) and moderate cellulitis.The events were considered medically significant.Action taken: unknown for both events.Corrective treatment: unspecified antibiotic for both events.The patient outcome is reported as unknown for septic arthritis and as unknown for cellulitis.A product technical complaint was initiated and the results for the same were pending reporter causality: unassessable for both events (unknown).Company causality: reportable for both events.

Event Description

Cellulitis [cellulitis].Septic arthritis [septic arthritis].Case narrative: initial information received on 08-dec-2020 regarding a solicited valid serious case received from a physician, in the scope of market research program "mrs_20-2318".Patient id: 03; country: mexico.Study title: ostheo psp evaluation.This case involves 21 years old male patient who experienced septic arthritis and cellulitis, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (strength: 16mg/2ml, with an unknown dose, frequency, route, batch/lot number, expiry date, indication).Information on batch number was requested.On an unknown date in sep-2015, after an unknown latency the patient experienced moderate septic arthritis (arthritis bacterial) and moderate cellulitis.Action taken: unknown for both events.Corrective treatment: unspecified antibiotic for both events.Outcome: unknown for both events.A product technical complaint was initiated and the results for the same were pending reporter causality: unassessable for both events (unknown).Company causality: reportable for both events.Seriousness criteria: medically significant for both events.A product technical complaint (ptc) was initiated on 08-dec-2020 for synvisc (batch number: unknown) with global ptc number 100106128.The sample status was not available.Ptc stated: the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.It is 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 (non-conformance) 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 has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.The final investigation was completed on 09-mar-2021 with summarized conclusion as no assessment possible.Additional information was received on 08-dec-2020 from healthcare professional (quality department).Ptc number was added.Text amended accordingly.Additional information was received on 09-mar-2021 from healthcare professional (quality department).Ptc number was added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 11002472
• MDR Text Key: 221719549
• Report Number: 2246315-2020-00168
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 21 YR
• Patient Sex: Male