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

Lot Number 7RSL021

Device Problems Contamination (1120); Nonstandard Device (1420); Device Contamination With Biological Material (2908)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091)

Event Date 11/15/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 09-jan-2018 from the patient this case concerns a (b)(6) male patient who initiated treatment with synvisc one and after few hours had inflammation, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.Patient was taking supplements of glucosamine/ chondroitin/msm.The patient has previously received synvisc-one in the right knee about once a year for the past 10 years.Patient's torn meniscus that was repaired in 2005.On (b)(6) 2017, at 9:45, patient received treatment with intra articular synvisc one injection at a dose of 1 df once (indication: not provided; batch/ lot number: 7rsl021 and expiry date: 31-may-2020) in right knee for knee pain related to osteoarthritis.On (b)(6) 2017, after few hours, patient developed pain and swelling in the right knee.The patient stated that as soon as the pain and swelling in the right knee started, he began to put ice on it, and the knee was better the next day, and then it got better each day, until by the end of that week it was almost back to normal.The patient stated that he may have taken some aspirin to treat the pain and swelling in the right knee also.The patient stated that while he was experiencing pain and swelling in the right knee, he did favor the knee when he was walking or climbing stairs, but he did not have to use a cane or walker or wheelchair.The patient stated that no fluid was drawn from the right knee, and no blood work was done at the time of the reaction.The patient stated that he did not think he had a fever during this time, and was not hospitalized.He stated that because of his right knee pain and inflammation he did have to stop going to the gym for about 5 days.Corrective treatment: ice and aspirin for inflammation; not reported for device malfunction outcome: recovering for both 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Pharmacovigilance comment: sanofi company comment dated 16-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee inflammation.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 spontaneous case from united states was received on 09-jan-2018 from the patient this case concerns a (b)(6) years old male patient who initiated treatment with synvisc one and after few hours had inflammation, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.Patient was taking supplements of glucosamine/ chondroitin/msm.The patient has previously received synvisc-one in the right knee about once a year for the past 10 years ((b)(6) 2006).Patient's torn meniscus that was repaired in (b)(6) 2005.On (b)(6) 2017, at 9:45, patient received treatment with intra articular synvisc one injection at a dose of 1 df once (indication: not provided; batch/ lot number: 7rsl021 and expiry date: 31-may-2020) in right knee for knee pain related to osteoarthritis.On (b)(6) 2017, after few hours, patient developed pain, swelling and stiffness in the right knee.The patient stated that as soon as the pain and swelling in the right knee started, he began to put ice on it, and the knee was better the next day, and then it got better each day, until by the end of that week it was almost back to normal.The patient stated that he may have taken some aspirin to treat the pain and swelling in the right knee also.The patient stated that while he was experiencing pain and swelling in the right knee, he did favor the knee when he was walking or climbing stairs, but he did not have to use a cane or walker or wheelchair.The patient stated that no fluid was drawn from the right knee, and no blood work was done at the time of the reaction.The patient stated that he did not think he had a fever during this time, and was not hospitalized.He stated that because of his right knee pain and inflammation he did have to stop going to the gym for about 5 days.Patient had now recovered from the symptoms.On (b)(6) 2018 patient received lab results which were fine.Corrective treatment: ice and aspirin for inflammation; not reported for device malfunction outcome: recovering for both events seriousness criteria: important medical event for device malfunction a pharmaceutical technical complaint (ptc) 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received on 18-jan-2018.Global ptc number was added.Additional information was received on 06-feb-2018 and 09-feb-2018 (processed with clock start date of 06-feb- 2018) from the patient.Symptom of stiffness in right knee was added.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company commentfor follow up dated 6-feb-2018:follow up information received does not change previous case assessment.This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee inflammation.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: 7218211
• MDR Text Key: 98586284
• Report Number: 2246315-2018-00158
• 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: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2018
• Patient Sequence Number: 1
• Treatment: CHONDROITIN W/GLUCOSAMINE(CON.) - ONGOING; SYNVISC ONE(PREV.)
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 77