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 Erythema (1840); Swelling (2091); Arthralgia (2355)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

(b)(4).This unsolicited case from united states was received on 03-nov-2017 from a non-healthcare professional.This case concerns a (b)(6) patient of unknown gender who received treatment with synvisc one and later after unknown latency the patient experienced swelling, redness, pain and difficult weight bearing on injected leg.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose: unknown) for osteoarthritis into the left knee (batch/ lot number: 7rsl021; expiry date: may-2020).On an unknown date in (b)(6) 2017, after unknown latency the patient experienced swelling, redness, pain and difficult weight bearing on injected leg.It was reported that the patient was told to ice affected knees, elevate affected legs and was given steroid packs and pain medicines corrective treatment: ice affected knees, elevate affected legs, steroid packs for redness, difficult weight bearing on injected leg and swelling; ice affected knees, elevate affected legs, steroid packs and pain medicines for pain.Outcome: unknown for all the events.Seriousness criteria: required intervention for pain, difficult weight bearing on injected leg, redness and swelling.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Pharmacovigilance comment: sanofi company comment dated 9-nov-2017: this case concerns a patient who received synvisc one injection and later had localized erythema and weight bearing difficulty in leg for which patient received steroid pack.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.

Event Description

This case is cross referenced with case: (b)(4).This unsolicited case from united states was received on 03-nov-2017 from a non-healthcare professional.This case concerns a (b)(6) patient of unknown gender who received treatment with synvisc one and later after unknown latency the patient experienced swelling, redness, pain and difficult weight bearing on injected leg.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose: unknown) for osteoarthritis into the left knee (batch/ lot number: 7rsl021; expiry date: may-2020).On an unknown date in (b)(6) 2017, after unknown latency the patient experienced swelling, redness, pain and difficult weight bearing on injected leg.It was reported that the patient was told to ice affected knees, elevate affected legs and was given steroid packs and pain medicines.Corrective treatment: ice affected knees, elevate affected legs, steroid packs for redness, difficult weight bearing on injected leg and swelling; ice affected knees, elevate affected legs, steroid packs and pain medicines for pain.Outcome: unknown for all the events seriousness criteria: required intervention for pain, difficult weight bearing on injected leg, redness and swelling a pharmaceutical technical complaint (ptc) was initiated and 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 as received on 22-nov-2017.Global ptc number was added.An additional event of device malfunction was added with details.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company follow up comment dated 20-dec-2017: this case concerns a patient who received synvisc one injection from recalled lot and later had localized erythema and weight bearing difficulty in leg for which patient received steroid pack.Based on the available information, temporal relationship can be established between the event and suspect product.Additionally, as the concerned lot number has been identified to have malfunction by the company.Hence, the pharmacological plausibility 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: 7032520
• MDR Text Key: 92043587
• Report Number: 2246315-2017-00180
• 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: 11/03/2017

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: Other
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 11/22/2017
• Supplement Dates FDA Received: 12/22/2017
• 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
• Patient Age: 58 YR