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 Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 12-feb-2018 from a patient.This case concerns female patient (age not provided) who experienced an infection of the throat, swelling, in a 2" diameter around her right knee, increased pain in that knee and drew fluid from her right knee after unknown latency of receiving treatment with synvisc one.Also device malfunction was identified for the reported lot number.No relevant concomitant medication or concurrent condition was provided.The patient had a meniscus repair on her right knee on (b)(6) 2017 and was doing outpatient physical therapy.She was allergic to lidocaine and latex, no chicken products or protein.On an unspecified date in (b)(6) 2017 (early december), the patient initiated treatment with intra-articular synvisc one injection 1 df once (batch/lot number: 7rsl021, expiry date: not provided) for right knee pain in right knee.The patient wanted to know if the microbe would be in her whole body and would it affect her throat.On an unspecified date in (b)(6) 2017 after unknown latency with the injection she experienced swelling, in a 2" diameter around her right knee and increased pain in that knee up to a 5, on a scale of 1- 10, 10 being the worst.She visited her doctor and he withdrew fluid from her right knee.He did not recommend any other treatments.She continued to have outpatient physical therapy after the synvisc one injection.The knee pain and swelling diminished gradually over the weeks post injection.She had no fever.She did start coughing and went to the er on (b)(6) 2017 for the cough and the diagnosis was an infection of the throat.She was given a course of azithromycin (z-pack) antibiotics.She continued to have the cough and sometimes coughs all through the day.She did see her family doctor for the cough.He did not prescribe a treatment.She did not walk with any assistive equipment after the injection.Corrective treatment: azithromycin (z-pack) antibiotics for an infection of the throat; drew fluid from her right knee for drew fluid from her right knee (effusion (r) knee); not reported for rest all the events outcome: unknown for drew fluid from her right knee and an infection of the throat; recovering for device malfunction, increased pain in that knee and swelling, in a 2" diameter around her right knee 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 16-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had throat infection, knee pain, swelling and effusion.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the product cannot be excluded.

Event Description

This unsolicited case from united states was received on 12-feb-2018 from a patient.This case concerns female patient (age not provided) who experienced an infection of the throat, swelling, in a 2" diameter around her right knee, increased pain in that knee and drew fluid from her right knee after unknown latency, after 20 days patient had upper leg (thigh) pain, an infection of the throat/acute pharyngitis, acute mouth sores under tongue and on gums, hip pain of receiving treatment with synvisc one.Also device malfunction was identified for the reported lot number.No relevant concurrent condition was provided.The patient had a tuboplasty (1980), c-section (1981,1982) meniscus repair on her right knee on (b)(6) 2017 and was doing outpatient physical therapy.She was allergic to lidocaine and latex, no chicken products or protein, lidocaine, rapid heart rate, sweaty palms and face, latex bandages, blisters.Concomitant medication was acetylsalicylic acid (aspirin), fenofibrate.On an (b)(6) 2017 the patient initiated treatment with intra-articular synvisc one injection 1 df once (batch/ lot number: 7rsl021, expiry date: not provided) for right knee pain in right knee.The patient wanted to know if the microbe would be in her whole body and would it affect her throat.On (b)(6) 2017 patient had upper leg (thigh) pain, an infection of the throat/acute pharyngitis followed by severe and continual coughing, acute mouth sores under tongue and on gums, hip pain.On an unspecified date in dec-2017 after unknown latency with the injection she experienced swelling, in a 2" diameter around her right knee and increased pain in that knee up to a 5, on a scale of 1-10, 10 being the worst.She visited her doctor and he withdrew fluid from her right knee.He did not recommend any other treatments.She continued to have outpatient physical therapy after the synvisc one injection.The knee pain and swelling diminished gradually over the weeks post injection.She had no fever.She did start coughing and went to the er on (b)(6) 2017 for the cough and the diagnosis was an infection of the throat.She was given a course of azithromycin (z-pack) antibiotics.She continued to have the cough and sometimes coughs all through the day.She did see her family doctor for the cough.He did not prescribe a treatment.She did not walk with any assistive equipment after the injection.Corrective treatment: azithromycin (z-pack) antibiotics for an infection of the throat/acute pharyngitis , an infection of the throat; drew fluid from her right knee for drew fluid from her right knee (effusion (r) knee); not reported for rest all the events outcome: unknown for drew fluid from her right knee and an infection of the throat; recovering for device malfunction, and swelling, in a 2" diameter around her right knee; not recovered for upper leg (thigh) pain, an infection of the throat/acute pharyngitis, acute mouth sores under tongue and on gums, increased pain in that knee, hip pain 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction.Follow up information was received on 26-feb-2018.Global ptc number was added.Text amended accordingly.Additional information was received on 07-may-2018 from patient.Events of hip pain, upper leg (thigh) pain, acute mouth sores under tongue and on gums was added.Concomitant medications and medical history was added.Verbatim updated for an infection of the throat/acute pharyngitis.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 07-may-2018: the follow up information received does not change previous company assessment.This case concerns a patient who has receievd synvisc one injection from the recalled lot and later had throat infection, knee pain, swelling and effusion.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to hasve malfunction by the company.Therefore, 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: 7295566
• MDR Text Key: 101258520
• Report Number: 2246315-2018-00335
• 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: 02/12/2018

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: 02/12/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 05/07/2018
• Supplement Dates FDA Received: 05/14/2018
• Patient Sequence Number: 1
• Treatment: ASPIRIN(CON.) - ONGOING; FENOFIBRATE(CON.)-ONGOING; LIDOCAINE(PREV.); LIDOCAINE(PREV.)
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 70