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

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Pain (1994); Swelling (2091); Reaction, Injection Site (2442)

Event Type  malfunction  

Event Description

(b)(4).This unsolicited case was received from united states on 28-feb-2018 from a patient.This case involves a (b)(6) female patient who received treatment with synvisc one and after unknown latency feels tight, fluid that could be aspirated, increased pain in right knee/very sore, swollen and very difficult to bend the knee.Also, device malfunction was identified for the reported lot number.No past drugs, medical history, concomitant medication or concurrent condition was reported.On an unknown, the patient received treatment with intra-articular synvisc one injection (dose and frequency and indication: not provided) (route, batch/ lot number: 7rsl021; and expiration date: unknown).On (b)(6) 2017, after unknown latency, the patient was very painful and swollen and left knee was fine.On an unknown date, after unknown latency, it was very difficult to bend the knee, felt tight and very sore to touch above the knee and right under the knee.On (b)(6) 2017, doctor saw patient on urgent basis and ran a musculoskeletal ultra sound probe over the knees.Doctor saw a small amount of fluid but thought it was interstitial fluid and thickening rather than a pocket of fluid that could be aspirated (onset date: unknown; latency: unknown).Action taken: unknown.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: important medical event for device malfunction.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.Pharmacovigilance comment: anofi company comment dated 28-feb-2018: this case concerns a male patient who received synvisc one injection from the recalled lot and had discomfort and knee effusion.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

Event Description

Device malfunction [device malfunction].Feels tight [discomfort].Fluid that could be aspirated [knee effusion].Increased pain in right knee/very sore [knee pain].Swollen [swelling of r knee].Very difficult to bend the knee [stiffness].Case narrative: this case is cross-referred to case id: (b)(4) (same reporter).This unsolicited case was received from (b)(6) on 28-feb-2018 from a patient.This case involves a 79 year old female patient who received treatment with synvisc one and after unknown latency feels tight, fluid that could be aspirated, increased pain in right knee/very sore, swollen and very difficult to bend the knee.Also, device malfunction was identified for the reported lot number.No past drugs, medical history, concomitant medication or concurrent condition was reported.On an unknown, the patient received treatment with intra-articular synvisc one injection (dose and frequency and indication: not provided) (route, batch/ lot number: 7rsl021; and expiration date: unknown).On (b)(6) 2018, after unknown latency, the patient was very painful and swollen and left knee was fine.On an unknown date, after unknown latency, it was very difficult to bend the knee, felt tight and very sore to touch above the knee and right under the knee.On (b)(6) 2017, doctor saw patient on urgent basis and ran a musculoskeletal ultra sound probe over the knees.Doctor saw a small amount of fluid but thought it was interstitial fluid and thickening rather than a pocket of fluid that could be aspirated (onset date: unknown; latency: unknown).Action taken: unknown.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: important medical event for device malfunction.A pharmaceutical technical complaint was initiated with global ptc number: (b)(4).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.Additional information was received on 06-mar-2018.Global ptc (pharmaceutical technical complaint) number was added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7334058
• MDR Text Key: 102755218
• Report Number: 2246315-2018-00383
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR