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

Lot Number 7RSL021

Device Problem Loss of Data (2903)

Patient Problems Arthralgia (2355); No Code Available (3191)

Event Date 11/14/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 27-dec-2017 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and later on the same day was unable to put pressure on her knees and little bit of swelling, after few hours had excruciating pain/ pain in her knees, was unable to walk.Also device malfunction was identified for the reported lot number.No concomitant medication or concurrent condition was provided.The medical history was significant for pain in knees (due to arthritis).The patient had past treatment with cortisone injections in both knees (a week or two before the synvisc one injections).On (b)(6) 2017, at 4:30 pm the patient initiated treatment with intra-articular synvisc one injection once (1 syringe both knees) for arthritis (batch/lot number: 7rsl021; expiry date: unknown) into both the knees.It was reported that before she got the synvisc one injection, the doctor did aspirate fluid out of the right knee.The same day at 8 pm that evening, the patient started experiencing excruciating pain and was unable to walk, it was terrible.The same day, the patient experienced a little bit of swelling, was unable to walk for 5 days and was unable to put pressure on her knees.The patient was told by the doctor to wait it out and to take ibuprofen.It was reported that the treatment with ibuprofen did not work.The patient used a walker, the kind that you sit on because she was unable to put pressure on her knees.Reportedly, the day after (b)(6) she went in and received cortisone injection in both knees.It was reported that the patient still experienced pain in her knees and they still felt real "full".The patient did not experience fever.Blood work was not performed.No further information was provided.Corrective treatment: walker for unable to put pressure on her knees; ibuprofen, cortisone for excruciating pain/ pain in her knees; not reported for little bit of swelling and unable to walk.Outcome: recovered for unable to walk; unknown for rest of 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.Seriousness criteria: required intervention for device malfunction and excruciating pain/ pain in her knees; disability for unable to put pressure on her knees pharmacovigilance comment: sanofi company comment dated 3-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and experiencing excruciating pain, was unable to walk and used walker because was unable to put pressure on knees.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
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7208792
• MDR Text Key: 98193367
• Report Number: 2246315-2018-00052
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2018
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 82