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)

Event Date 11/09/2017

Event Type  Injury  

Event Description

Device malfunction [device malfunction].Increased edema in joint [edema knees].Pain in joint [joint pain].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 21-mar-2018 from a non-healthcare professional via health authority of united states (us-fda with regulatory reference number: mw5075449).This case involves a patient of unknown demographics who received treatment with synvisc one and later after unknown latency had increased edema in joint and pain in joint.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date in 2017, the initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for bilateral knee pain (batch/lot number: 7rsl021; expiration date: 31-may-2020) for bilateral knee pain.On (b)(6) 2017, after unknown latency, the patient had increased edema and pain in joint.It was reported that the event abated after stopping treatment with synvisc one.Corrective treatment: not reported for all the events.Outcome: recovering for all the events.Seriousness criteria: medically significant for all the 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 would be completed, corrective and preventive actions would be implemented.Pharmacovigilance comment: sanofi company comment dated 30-mar-18.This case concerns a patient who received treatment with synvisc one from recall lot and later experienced edema in knees and joint pain.Since the date of product of administration is unknown a significant temporal relationship can't be established.However the causal role of suspect product can also not be excluded in occurrence of the event.Furthermore, the concerned lot number has been identified to have malfunction by the company.Moreover due to lack of information regarding medical history, concomitant medications, investigation details and past drugs complete medical assessment of the case is difficult.

Event Description

This unsolicited case from united states was received on 21-mar-2018 from a non-healthcare professional via health authority of united states (us-fda with regulatory reference number: mw5075449).This case involves a patient of unknown demographics who received treatment with synvisc one and later after unknown latency had increased edema in joint and pain in joint.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date in 2017, the initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for bilateral knee pain (batch/lot number: 7rsl021; expiration date: 31-may-2020) for bilateral knee pain.On (b)(6) 2017, after unknown latency, the patient had increased edema and pain in joint.It was reported that the event abated after stopping treatment with synvisc one.Corrective treatment: not reported for all the events.Outcome: recovering for all the events.Seriousness criteria: medically significant for all the 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 would be completed, corrective and preventive actions would be implemented.Pharmacovigilance comment: sanofi company comment dated 30-mar-2018.This case concerns a patient who received treatment with synvisc one from recall lot and later experienced edema in knees and joint pain.Since the date of "product" of administration is unknown a significant temporal relationship can't be established.However the causal role of suspect product can also not be excluded in occurrence of the event.Furthermore, the concerned lot number has been identified to have malfunction by the company.Moreover due to lack of information regarding medical history, concomitant medications, investigation details and past drugs complete medical assessment of the case is difficult.

• 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: 7402734
• MDR Text Key: 213240590
• Report Number: 2246315-2018-00436
• 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
• Reporter Occupation: Other
• 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

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• 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