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); Arthralgia (2355); Joint Swelling (2356)

Event Date 11/03/2017

Event Type  malfunction  

Event Description

(b)(4).This spontaneous case from united states was received on 03-nov-2017 from a non-healthcare professional.This case concerns a (b)(6) patient (sex: not provided) who received treatment with synvisc one and after an unknown latency patient reported swelling, redness, pain, difficult weight bearing on injected leg.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose: not provided) for osteoarthritis with batch/ lot number: 7rsl021 and expiry date: may-2020.On an unknown date in (b)(6) 2017, after an unknown latency, patient reported swelling, redness, pain, difficult weight bearing on injected leg.Patient was told to ice affected knees, elevate affected legs and was given steroid packs.Corrective treatment: ice affected knees, elevate affected legs, steroid packs and pain meds for pain; ice affected knees, elevate affected legs, steroid packs for all other events outcome: unknown for all events seriousness criteria: required intervention for all events a pharmaceutical technical complaint (ptc) was initiated and the result of the same was pending.Pharmacovigilance comment: sanofi company comment dated 9-nov-2017: this case concerns a patient who received treatment with synvisc one and later experienced weight bearing difficulty and localized redness with knee pain and swelling.A significant temporal relationship can be established on the basis of temporal gap.Furthermore, on the basis of site of reactions causal role of suspect product cannot be denied in occurrence of the event.However, due to lack of information regarding medical history, concurrent condition and past drugs precludes complete medical assessment of the case.

Event Description

This case was cross referenced with cases: (b)(4).This spontaneous case from united states was received on (b)(6) 2017 from a non-healthcare professional.This case concerns a (b)(6) patient (sex: not provided) who received treatment with synvisc one and the next day the patient reported swelling, redness, pain/ hurt to put pressure on the knee with standing, difficult weight bearing on injected leg/ difficulty putting pressure on knee when standing.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose: not provided) for osteoarthritis with batch/ lot number: 7rsl021 and expiry date: may-2020.On (b)(6) 2017, the patient experienced swelling, redness, pain, difficult weight bearing on injected leg (latency: 1 day).Patient was told to ice affected knees, elevate affected legs and was given steroid packs.Patient had swelling, redness, had difficulty putting pressure on the knee when standing and it hurt to put pressure on the knee while standing.Corrective treatment: ice affected knees, elevate affected legs, steroid packs and pain meds for pain/ hurt to put pressure on the knee with standing; ice affected knees, elevate affected legs, steroid packs for all other events outcome: unknown for all events seriousness criteria: required intervention for all events a pharmaceutical technical complaint (ptc) was initiated and the result of the same was pending.Additional information was received on 06-nov-2017.Event onset date was updated.Event verbatim was updated from difficult weight bearing on injected leg to difficult weight bearing on injected leg/ difficulty putting pressure on knee when standing; pain to pain/ hurt to put pressure on the knee with standing.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 6-nov-2017: the follow up information received doesnot change previous case assessment.This case concerns a patient who received treatment with synvisc one and later experienced weight bearing difficulty and localized redness with knee pain and swelling.A significant temporal relationship can be established on the basis of temporal gap.Furthermore, on the basis of site of reactions causal role of suspect product cannot be denied in occurrence of the event.However, due to lack of information regarding medical history, concurrent condition and past drugs precludes complete medical assessment of the case.

Event Description

This case was cross referenced with cases: (b)(4) (cluster).This spontaneous case from united states was received on (b)(6) 2017 from a non-healthcare professional.This case concerns a (b)(6) patient (sex: not provided) who received treatment with synvisc one and the next day the patient reported swelling, redness, pain/ hurt to put pressure on the knee with standing, difficult weight bearing on injected leg/ difficulty putting pressure on knee when standing.No medical history, concomitant medications and concurrent conditions were reported.Patient had both knees treated on (b)(6) 2017 without reaction.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose: not provided) for osteoarthritis with batch/ lot number: 7rsl021 and expiry date: may-2020.On (b)(6) 2017, the patient experienced swelling, redness, pain, difficult weight bearing on injected leg (latency: 1 day).Patient was told to ice affected knees, elevate affected legs and was given steroid packs.Patient had swelling, redness, had difficulty putting pressure on the knee when standing and it hurt to put pressure on the knee while standing.Corrective treatment: ice affected knees, elevate affected legs, steroid packs and pain meds for pain/ hurt to put pressure on the knee with standing; ice affected knees, elevate affected legs, steroid packs for all other events.Outcome: unknown for all events.Seriousness criteria: required intervention for all events.A pharmaceutical technical complaint (ptc) was initiated and the result of the same was pending.Additional information was received on 06-nov-2017.Event onset date was updated.Event verbatim was updated from difficult weight bearing on injected leg to difficult weight bearing on injected leg/ difficulty putting pressure on knee when standing; pain to pain/ hurt to put pressure on the knee with standing.Clinical course was updated.Text was amended accordingly.Follow up was received on 06-nov-2017.No new information was received.Additional information was received on 16-nov-2017.Information about patient past treatment with synvisc one was provided.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 16-nov-2017: the follow up information received doesnot change previous case assessment.This case concerns a patient who received treatment with synvisc one and later experienced weight bearing difficulty and localized redness with knee pain and swelling.A significant temporal relationship can be established on the basis of temporal gap.Furthermore, on the basis of site of reactions causal role of suspect product cannot be denied in occurrence of the event.However, due to lack of information regarding medical history, concurrent condition and past drugs precludes complete medical assessment of the case.

Event Description

This case was cross referenced with cases: (b)(4) (cluster) this spontaneous case from united states was received on 03-nov-2017 from a non-healthcare professional.This case concerns a (b)(6) years old patient (sex: not provided) who received treatment with synvisc one and the next day the patient reported swelling, redness, pain/ hurt to put pressure on the knee with standing, difficult weight bearing on injected leg/ difficulty putting pressure on knee when standing.Also, device malfunction was identified for the reported lot number.No medical history, concomitant medications and concurrent conditions were reported.Patient had both knees treated on (b)(6) 2017 without reaction.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose: not provided) for osteoarthritis with batch/ lot number: 7rsl021 and expiry date: may-2020.On (b)(6) 2017, the patient experienced swelling, redness, pain, difficult weight bearing on injected leg (latency: 1 day).Patient was told to ice affected knees, elevate affected legs and was given steroid packs.Patient had swelling, redness, had difficulty putting pressure on the knee when standing and it hurt to put pressure on the knee while standing.Corrective treatment: ice affected knees, elevate affected legs, steroid packs and pain meds for pain/ hurt to put pressure on the knee with standing; ice affected knees, elevate affected legs, steroid packs for all other events.Outcome: unknown for all events.Seriousness criteria: required intervention for all events.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.Additional information was received on 06-nov-2017.Event onset date was updated.Event verbatim was updated from difficult weight bearing on injected leg to difficult weight bearing on injected leg/ difficulty putting pressure on knee when standing; pain to pain/ hurt to put pressure on the knee with standing.Clinical course was updated.Text was amended accordingly.Follow up was received on 06-nov-2017.No new information was received.Additional information was received on 16-nov-2017.Information about patient past treatment with synvisc one was provided.Clinical course was updated.Text was amended accordingly.Additional information was received on 22-nov-2017 and 13-dec-2017 (all information processed with clock start date of 22-nov-2017).Event of device malfunction was added.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi follow-up company comment dated 22-nov-2017: this case concerns a patient who received treatment with synvisc one and later experienced weight bearing difficulty and localized redness with knee pain and swelling.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: 7040160
• MDR Text Key: 92309163
• Report Number: 2246315-2017-00183
• 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,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• 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: 60 YR