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

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/06/2017

Event Type  malfunction  

Event Description

This case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on (b)(6) 2017 from the health care professional.This case concerns an (b)(6) years old female patient who received treatment with synvisc one and later after few days had left knee pain and swelling.No relevant medical history, past medications, concurrent conditions and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once at a dose of 6 ml (lot number: 7rsl021; expiration date: may 31, - 2020) for osteoarthritis into the left knee.On an unknown date in (b)(6) 2017, few days after starting treatment the patient had left knee pain and swelling.On (b)(6) 2017, it was reported that the patient was given methylprednisolone acetate (depo-medrol) injection 40 mg.Corrective treatment: methylprednisolone acetate injection for both the events.Outcome: unknown for both the injections seriousness criteria: required intervention for both the events a pharmaceutical technical complaint (ptc) was initiated with ptc number: (b)(4).

Event Description

This case was cross referenced with (b)(4).This unsolicited case from united states was received on 06-dec-2017 from the health care professional.This case concerns an (b)(6) years old female patient who received treatment with synvisc one and later after few days had left knee pain and swelling, also, device malfunction was identified for the reported lot number.No relevant medical history, past medications, concurrent conditions and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once at a dose of 6 ml (lot number: 7rsl021; expiration date: 31-may- 2020) for osteoarthritis into the left knee.On an unknown date in (b)(6) 2017, few days after starting treatment the patient had left knee pain and swelling.On (b)(6) 2017, it was reported that the patient was given methylprednisolone acetate (depo-medrol) injection 40mg.Corrective treatment: not reported for device malfunction; methylprednisolone acetate injection for other events.Outcome: unknown for all events.Seriousness criteria: required intervention for all the events.A pharmaceutical technical complaint (ptc) was initiated with 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 06-dec-2017 and 02-jan-2018 (processed with clock start date of 06-dec- 2017).Global ptc number and ptc results were added.An additional event of device malfunction was added.Pharmacovigilance comment: sanofi company comment for follow up dated 06-dec-2017: this case concern a female patient who received synvisc one injection from the recalled lot and had left knee swelling and pain.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 case was cross referenced with (b)(4).This unsolicited case from united states was received on 06-dec-2017 from the health care professional.This case concerns an (b)(6) years old female patient who received treatment with synvisc one and on the same day had left knee pain and swelling, also, device malfunction was identified for the reported lot number.No relevant past medications were reported.Patient had no known drug allergies.Patient had carpal tunnel, carpal tunnel and osteoarthritis knee.Concomitant medications include methotrexate, infliximab (remicade), solifenacin succinate (vesicare), aledronate sodium and naproxen sodium (aleve).On (b)(6) 2017, at 08:53, the patient received treatment with intra-articular synvisc one injection, once at a dose of 6 ml (lot number: 7rsl021; expiration date: 31-may-2020) for osteoarthritis into the left knee.On the same day, after starting treatment the patient had left knee pain and swelling.It was reported that the patient had worsening knee pain and swelling.On (b)(6) 2017, it was reported that the patient was given methylprednisolone acetate (depo-medrol) injection 40mg.Corrective treatment: not reported for device malfunction; methylprednisolone acetate injection for other events outcome: recovered for all events seriousness criteria: required intervention for all the events a pharmaceutical technical complaint (ptc) was initiated with 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 06-dec-2017 and 02-jan-2018 (processed with clock start date of 06-dec- 2017).Global ptc number and ptc results were added.An additional event of device malfunction was added.Additional information was received on 19-jan-2018.Worsening knee pain and swelling was added as symptom of left knee swelling.Event start dates was updated.Concomitant medication and medical history added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 06-dec-2017: this case concern a female patient who received synvisc one injection from the recalled lot and had left knee swelling and pain.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: 7156218
• MDR Text Key: 96112282
• Report Number: 2246315-2017-00279
• 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,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2017
• 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: 01/19/2018
• Patient Sequence Number: 1
• Treatment: ALEDRONATE SODIUM(CON.); ALEVE(CON.); METHOTREXATE(CON.); REMICADE(CON.); VESICARE(CON.)
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR