MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Edema (1820); Swelling (2091); Ambulation Difficulties (2544)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(6) 2018 from physician.This case concerns a (b)(6) year old male patient who received treatment with synvisc one and after an unknown latency patient biggest issue was the patient transferring weight, inability to move/could not move the left knee, peripheral edema was on the left side and swelling.Also, device malfunction was identified for the reported lot number.No medical history, concomitant medications and concurrent conditions were reported.The patient had synvisc-one injections in the past but the date he began injections was not known.On (b)(6) -2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (lot number: 7rsl021; indication and expiration date: not reported) bilaterally in knees.On an unknown date in (b)(6) 2017, latency unknown, it was reported that only left knee presented with symptoms including swelling and inability to move/ could not move the left knee.The patient met with the hcp (health care professional) on (b)(6) 2017; an ultrasound was done and no abnormalities were shown but peripheral edema was on the left side.It was reported that the biggest issue was the patient transferring weight.The patient was seen again by hcp on (b)(6) 2017 for follow-up and the symptoms had resolved.No pain levels or fever were reported.No treatment options were mentioned.Corrective treatment: not reported for all events.Outcome: recovered 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 01-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had peripheral edema, weight bearing difficulty and had mobility decreased.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

This unsolicited case from united states was received on 29-jan-2018 from physician.This case concerns a 74 year old male patient who received treatment with synvisc one and after 1 day had inability to move/could not move the left knee, swelling and bilateral knee pain; after an unknown latency patient biggest issue was the patient transferring weight peripheral edema was on the left side.Also, device malfunction was identified for the reported lot number.No medical history, concomitant medications and concurrent conditions were reported.The patient had synvisc-one injections in the past but the date he began injections was not known.Patient had a history of lower extremity naprapathy.Concomitant medications included: atorvastatin calcium (lipitor), amlodipine besilate (norvasc), bupropion hydrochloride (wellbutrin), loxapine on (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (lot number: 7rsl021; indication and expiration date: not reported) bilaterally in knees for osteoarthritis bilateral knees.On (b)(6) 2017, after a latency of 1 day patient could not move and had bilateral knee pain and swelling.On an unknown date in (b)(6) 2017, latency unknown, it was reported that only left knee presented with symptoms including swelling and inability to move/ could not move the left knee.The patient met with the hcp (health care professional) on (b)(6) 2017; an ultrasound was done and no abnormalities were shown but peripheral edema was on the left side.It was reported that that the biggest issue was the patient transferring weight.The patient was seen again by hcp on (b)(6) 2017 for follow-up and the symptoms had resolved.No pain levels or fever were reported.No treatment options were mentioned.Corrective treatment: not reported for all events outcome: recovered for all the events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 52313 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction additional information was received on 02-feb-2018.Global ptc number was added.Additional information was received on 05-mar-2018 from the patient.Suspect indication was added.Event of bilateral knee pain was added.Concomitant medications and medical history was added.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 05-mar-18.The follow up received does not change the previous assessment of the case.: this case concerns a patient who has received synvisc one injection from the recalled lot and later had peripheral edema, weight bearing difficulty and had mobility decreased.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.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• MDR Report Key: 7296074
• MDR Text Key: 101247998
• Report Number: 2246315-2018-00277
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Patient Sequence Number: 1
• Treatment: LIPITOR(CON.); LOXAPINE(CON.); NORVASC(CON.); SYNVISC ONE(PREV.); SYNVISC ONE(PREV.); WELLBUTRIN(CON.)
• Patient Outcome(s): Other
• Patient Age: 74 YR