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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Edema (1820); Arthralgia (2355); Joint Swelling (2356)

Event Date 11/16/2017

Event Type  malfunction  

Event Description

Device malfunction.Swelling in the left knee as well as entire lower leg, oedema peripheral.Pain in the left knee.Swelling in the left knee.Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request.This unsolicited case from united states was received on (b)(6) 2018 from a healthcare professional via health authority (usa-fda: food and drug administration: mw5074656).This case concerns a patient (demographics unspecified) who received treatment with synvisc one and after unknown latency had swelling in the left knee as well as entire lower leg, pain in the left knee and swelling in the left knee.Also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication or concurrent condition was provided.On an unknown date in 2017, the patient initiated treatment with intra-articular synvisc one injection, once (batch/lot number: 7rsl021).On (b)(6) 2017, after unknown latency, patient reported pain and swelling in the left knee as well as entire lower leg.Patient was calmed down no redness or fever at this time.Corrective treatment: not reported for all events.Outcome: unknown for all events.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: medically significant for all events.Pharmacovigilance comment: (b)(6) company comment dated (b)(6) 2018: this case concerns a female patient who was on treatment with synvisc one from recall lot and experienced pain and swelling in the left knee as well as entire lower leg.The role of the drug cannot be denied for the occurrence of the events due to the suspect product.However, further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.

• Brand Name: SYNVISC ONE
• 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: 10453925
• MDR Text Key: 204872936
• Report Number: 2246315-2020-00107
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/26/2020

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?: Yes
• Device Operator: No Information
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2020
• 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): Other