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 Pain (1994); Swelling (2091); Reaction, Injection Site (2442)

Event Date 11/16/2017

Event Type  malfunction  

Event Description

Based on the information received on 06-feb-2018, the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This case is cross referred with the (b)(4) (cluster).This unsolicited case from united states was received on 12-dec-2017 from a pharmacist.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and after unknown latency had knee discomfort; after one day had swelling and pain.Also, device malfunction was identified for the reported lot number.Medical history included pain and osteoarthritis.Patient did not have prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator.Patient had osgood-schlatter disease and multiple varicose veins.Patient had penicillin allergy.Concomitant medications include allopurinol, levothyroxine sodium (levothyroxine), pantoprazole sodium (protonix), hydrocodone bitartrate/paracetamol (lortab) and warfarin.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection once (batch/lot number: 7rsl021 and expiry date: may-2020; dose: not provided) in right knee for osteoarthritis.It was reported that the alcohol preparation was done, patient was injected and band-aid was put on injection site.Also the product was stored at room temperature.On an unknown date in (b)(6) 2017, after unknown latency (1-2 days), patient had knee discomfort.On (b)(6) 2017, after one day of receiving injection, patient had swelling and pain.It was reported that the pain worsened after injection and the patient did not engage in activities such as jogging or tennis soon after the injection.Patient was encouraged not to keep knee stiff.Patient had swollen and painful knee.Patient had no fever and chills.On (b)(6) 2017, at 14:50, sample was drawn, results showed auto lymphocytes: 16.9 (low; reference range: 19-45 %); lymphocytes abs-auto was 1.03 (low; reference range: 1.09- 3.58 x 10e3/mcl) corrective treatment: ice and elevation for all events.Outcome: recovered for knee discomfort; not recovered for swelling and pain.A pharmaceutical technical complaint (ptc) was initiated with global (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 23-jan-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 06-feb-2018.This case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.Outcome was updated for the event of swelling and pain from recovered to not recovered.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi follow-up company comment dated: 06-feb-2018: this case concerns a (b)(6) male patient who received synvisc one for osteoarthritis.Later patient had knee pain, knee swelling , discomfort in joints.A temporal relationship can be established with the product administration.Also, the concerned lot number has been identified to have malfunction by the company.Thus, 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: 7279699
• MDR Text Key: 100656433
• Report Number: 2246315-2018-00313
• 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: health professional
• Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/12/2017

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: Health Professional
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/19/2018
• 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): Other
• Patient Age: 54 YR
• Patient Weight: 125