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 Bacterial Infection (1735); Pain (1994); Swelling (2091); Toxicity (2333)

Event Date 11/27/2017

Event Type  malfunction  

Event Description

Based on additional information received on 06-dec- 2017, this case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.This unsolicited case from united states was received on 06-dec-2017 from the other non-health care professional.This case concerns a patient (demographics unspecified) who received treatment with synvisc one injection and after unknown latency the patient had both knees in pain and one was swollen.Also, device malfunction was identified for the reported lot number.No relevant medical history, past medications and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the 6 ml once (lot number: 7rsl021 and expiration date: not reported) for osteoarthritis knee (oak) bilaterally.On (b)(6) 2017, 3 days after receiving the injection, the patient came back with pain in both the knees and one was swollen.Patient was starting to feel better.No aspiration was done.Corrective treatment: not reported.Outcome: unknown.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 was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction additional information was received on 06-dec-2017 and 14-dec-2017 (both information processed together with clock start date of 06-dec-2017).This case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.Event of device malfunction was added.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow-up dated 6-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pain in both knees and swollen knee.A temporal relationship can be established with the product administration.In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.

Event Description

Based on additional information received on 22-jan- 2018, this case became medically confirmed (from physician) based on additional information received on 06-dec- 2017, this case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.This unsolicited case from united states was received on 06-dec-2017 from the other non-health care professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and on the same day the patient had synovitic reaction.Also, device malfunction was identified for the reported lot number.No relevant concomitant medications were reported.Patient had drug allergy to fexofenadine hydrochloride (allegra).Patient had bilateral knee degenerative joint disease on (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the 6 ml once (lot number: 7rsl021 and expiration date: 31-may-2020) for osteoarthritis knee (oak) bilaterally.On the same day after receiving the injection, the patient came back with pain in both the knees and one was swollen.Patient was starting to feel better.On (b)(6) 2017, patient had bilateral knee effusions r>l.It was reported that patient had synovitic reaction corrective treatment: ibuprofen (motrin) outcome: unknown 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 was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction additional information was received on 06-dec-2017 and 14-dec-2017 (both information processed together with clock stat date of 06-dec-2017).This case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.Event of device malfunction was added.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 22-jan-2018 from physician.This case became medically confirmed.Patient details updated.Events of both knees in pain and one was swollen was updated from diagnosis to symptom of synovitic reaction.Expiration date added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow-up dated 22-jan-2018: the additional information does not alter the previous case assessment.This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pain in both knees and swollen knee.A temporal relationship can be established with the product administration.In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product 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: 7164961
• MDR Text Key: 97003101
• Report Number: 2246315-2017-00458
• 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,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

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: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 02/12/2018
• Patient Sequence Number: 1
• Treatment: ALLEGRA(PREV.)
• Patient Outcome(s): Other
• Patient Age: 77 YR