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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Knee replacement [joint replacement].Case narrative: this case is cross referenced with case id (b)(4).Initial information received on 30-may-2018 from united states regarding an unsolicited valid serious case received from consumer (patients acquaintance).This case involves a female patient of unknown demographics who experienced knee replacement (latency: unknown) after receiving synvisc-one injection.The past medical history, medical treatment(s), vaccination(s) and family history of the patient were not provided.On an unknown date, the patient received intra-articular injection of synvisc-one (dose, frequency and batch number: unknown).On an unknown date, the patient underwent knee replacement (latency: unknown).It was not reported if the patient received a corrective treatment.Seriousness criterion: medically significant.Outcome: unknown.Upon internal review on 27-nov-2018, the following changes were made in the case, this batch was identified in context of affiliates requests and concerns the field reporter causality which was amended from not reported to related in context of unsolicited report.

Manufacturer Narrative

Sanofi company comment dated 30-may-2018.The follow up information does not change the previous assessment of the case.Patient underwent knee replacement after receiving synvisc one.A significant temporal relationship can not be established and causal role of suspect product can not be assessed.Case will be re-evaluated post further update on patients medical history, concurrent conditions, concomitant conditions past drugs, suspect drug details and event details.

Event Description

Knee replacement [joint replacement].Case narrative: this case is cross referenced with case id (b)(4).Initial information received on 30-may-2018 from united states regarding an unsolicited valid serious case received from consumer (patients acquaintance).This case involves a female patient of unknown demographics who experienced knee replacement (latency: unknown) after receiving synvisc-one injection.The past medical history, medical treatment(s), vaccination(s) and family history of the patient were not provided.On an unknown date, the patient received intra-articular injection of synvisc-one (dose, frequency and batch number: unknown).On an unknown date, the patient underwent knee replacement (latency: unknown) it was not reported if the patient received a corrective treatment.Seriousness criterion: medically significant outcome: unknown.Upon internal review on 27-nov-2018, the following changes were made in the case, this batch was identified in context of affiliates requests and concerns the field reporter causality which was amended from not reported to related in context of unsolicited report.Upon internal review on 09-jan-2019 with the clock start date of 30-may-2018, the device malfunction incorrectly captured as 'yes' was corrected.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 8200899
• MDR Text Key: 132923346
• Report Number: 2246315-2018-00844
• 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
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention