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 Problem Pain (1994)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on (b)(6) 2018 from patient.This case concerns a (b)(6) female patient who initiated treatment with synvisc one and after an unknown latency could barely move that leg and pain also, device malfunction was identified for the reported lot number.No previous medications, concomitant medications and concurrent conditions were reported.Patient had left knee replacement.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once (indication: not provided; batch/ lot number: 7rsl021 and expiry date: unknown).On an unknown date, after an unknown latency, patient had a lot of pain and it really didn't help that much.She didn't get any treatment for pain.She was told to ice her knee.She could barely move that leg.She still had pain.Corrective treatment: ice for pain; not reported for could barely move that leg outcome: not recovered for pain; unknown for all other events seriousness criteria: important medical event for device malfunction 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.Pharmacovigilance comment: sanofi company comment dated 01-feb-2018: this case concerns a male patient who received synvisc one injection from the recalled lot and had pain and could barely move his leg.A temporal relationship can be established between the product and the events.Moreover, 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 spontaneous case from united states was received on 24-jan-2018 from patient.This case concerns a (b)(6) years old female patient who initiated treatment with synvisc one and the same day patient had pain/lot of pain in the (r) knee; after an unknown latency could barely move that leg and was pregnant during treatment; also device malfunction was identified for the reported lot number.No previous medications were reported.The patient had no allergies to bird and no diabetes.The medical history was significant for left knee replacement, unspecified disaster, cannot bend the knee, arthritis and vertigo.Allergy history included allergy to morphine, celecoxib (celebrex), hydromorphone hydrochloride ((dilaudid) made patient sick, stomach).Concomitant medications included verapamil hydrochloride (verapamil) for high blood pressure (hbp), sumatriptan (imitrex) for migraine, cimetidine and dexlansoprazole (dexilant) for acid reflux and montelukast for allergies.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once (indication: not provided; batch/ lot number: 7rsl021 and expiry date: unknown) into the right knee.The same day, patient had a lot of pain in the right knee and it really didn't help that much/ had not felts any difference.She didn't get any treatment for pain.She was told to ice her knee.She could barely move that leg.She still had pain.The patient was of good health and hygiene.No laboratory or medical tests were done for the event.The date of last menstrual period (lmp) was unspecified.On an unknown date, after unknown latency the patient was pregnant during the treatment with synvisc one.Corrective treatment: ice for pain/lot of pain in the (r) knee; not reported for could barely move that leg outcome: not recovered for pain/lot of pain in the (r) knee and device malfunction; unknown for could barely move that leg a global pharmaceutical technical complaint was initiated with gptc 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 will be implemented.Seriousness criteria: important medical event for device malfunction additional information was received on 07-feb-2018.The global ptc number was added.Text amended accordingly.Additional information was received on 20-feb-2018 from the patient.Medical history, concurrent condition and concomitant medications were added.Additional event of pregnant during treatment was added with details.Verbatim of pain/lot of pain in the (r) knee and really didn't help that much/have not felt any difference was updated.Event onset date was updated for pain/lot of pain in the (r) knee and device malfunction.Clinical course was updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 20-feb-2018: the follow up information did not change the previous case assessment.This case concerns a male patient who received synvisc one injection from the recalled lot and had pain and could barely move his leg.A temporal relationship can be established between the product and the events.Moreover, 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 spontaneous case from united states was received on (b)(6) 2018 from patient.This case concerns a 66 years old female patient who initiated treatment with synvisc one and the same day patient had pain/lot of pain in the (r) knee; after an unknown latency could barely move that leg and was pregnant during treatment; also device malfunction was identified for the reported lot number.No previous medications were reported.Before this shot, many months before patient had pain right knee.The patient had no allergies to bird and no diabetes.The medical history was significant for left knee replacement, unspecified disaster, cannot bend the knee, arthritis, vertigo.Allergy history included allergy to morphine, celecoxib (celebrex), hydromorphone hydrochloride ((dilaudid) made patient sick, stomach) and outdoor allergies.Concomitant medications included verapamil hydrochloride (verapamil) for high blood pressure (hbp), sumatriptan (imitrex) for migraine, cimetidine and dexlansoprazole (dexilant) for acid reflux, montelukast for allergies, naproxen sodium (aleve) and meloxicam for arthritis.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once (indication: not provided; batch/ lot number: 7rsl021 and expiry date: unknown) into the right knee.The same day, patient had a lot of pain in the right knee and it really didn't help that much/ had not felts any difference.She didn't get any treatment for pain.She was told to ice her knee.She could barely move that leg.She still had pain.The patient was of good health and hygiene.No laboratory or medical tests were done for the event.The date of last menstrual period (lmp) was unspecified.On an unknown date, after unknown latency the patient was pregnant during the treatment with synvisc one.It was reported that after the shot, no improvement at all, still patient was having pain and increasing.Corrective treatment: ice for pain/lot of pain in the (r) knee; not reported for could barely move that leg outcome: not recovered for pain/lot of pain in the (r) knee and device malfunction; unknown for could barely move that leg a global pharmaceutical technical complaint was initiated with gptc 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 will be implemented.Seriousness criteria: important medical event for device malfunction additional information was received on 07-feb-2018.The global ptc number was added.Text amended accordingly.Additional information was received on 20-feb-2018 from the patient.Medical history, concurrent condition and concomitant medications were added.Additional event of pregnant during treatment was added with details.Verbatim of pain/lot of pain in the (r) knee and really didn't help that much/have not felt any difference was updated.Event onset date was updated for pain/lot of pain in the (r) knee and device malfunction.Clinical course was updated.Text amended accordingly.Additional information was received on 05-mar-2018 from the patient.Medical history and concomitant medications were added.Symptom for the event of pain/lot of pain in the (r) knee was added.Clinical course was updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 05-mar-2018: the follow up information did not change the previous case assessment.This case concerns a male patient who received synvisc one injection from the recalled lot and had pain and could barely move his leg.A temporal relationship can be established between the product and the events.Moreover, 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: 7265952
• MDR Text Key: 100273550
• Report Number: 2246315-2018-00263
• 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,Followup
• Report Date: 01/24/2018

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 Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 03/05/2018
• Supplement Dates FDA Received: 03/07/2018; 03/19/2018
• Patient Sequence Number: 1
• Treatment: ALEVE(CON.) START.; CELEBREX(PREV.).; CELEBREX(PREV.).; CIMETIDINE(CON.).; CIMETIDINE(CON.).; DEXILANT(CON.).; DEXILANT(CON.).; DILAUDID(PREV.).; DILAUDID(PREV.).; IMITREX(CON.) START.; IMITREX(CON.).; MELOXICAM(CON.) START.; MONTELUKAST(CON.) START.; MONTELUKAST(CON.).; MORPHINE(PREV.).; MORPHINE(PREV.).; VERAPAMIL(CON.)-START.; VERAPAMIL(CON.)-START.
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 86