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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID
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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)
Event Date 11/03/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on (b)(6) 2018 from a patient.This case involves a (b)(6) female patient who received treatment with synvisc one and on the same day could not put weight on either knee, couldn't walk, knee swelling, knee pain.Also, device malfunction was identified for the reported lot number.No relevant past drugs were reported.Relevant medical history included surgery in 2005.Relevant concurrent conditions included sjogren's for which patient was being treated with hydroxychloroquine sulfate (plaquenil).The patient stated that she has no history of allergy to chicken, feathers, eggs, or other bird protein on (b)(6) 2017, the patient received an injection of the recalled lot of synivsc-one, once (route: intraarticular; lot/batch number: 7rsl021; indication: not provided) in each knee.The patient stated that she had never received synvisc or synvisc-one before, prior to (b)(6) 2017.That same evening, the patient began to experience a lot of swelling and a lot of pain in both knees, she could not put weight on either knee, and she could not walk, and these symptoms persisted for several days before improving; then, on (b)(6) 2017, the pain, swelling, unable to bear weight on her knees, and inability to walk, started all over again.The patient stated that she had experienced pain and swelling in both knees off and on ever since then.On a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain, the patient estimated her knee pain at its worst, after the synivsc-one injections, as a 9.The patient stated that the pain was severe enough that she was tempted to go to the emergency room, but she did not, and she stated she had not been hospitalized for her adverse knee symptoms.The patient stated that she called her doctor's office, and they asked if she had any pain medication around the house, which she did, so she treated her pain with some hydrocodone bitartrate/paracetamol (hydrocodone w/acetaminophen) 5/500 that she had left over from surgery in 2005, and the patient stated it was expired.The patient was currently treating her knee symptoms with some acetaminophen daily, ice, and elevation.The patient stated that she could not take naproxen because it increases her blood pressure.The patient stated that she engaged in no strenuous physical activities such as tennis or jogging after the synvisc-one injections.The patient stated that she had experienced no fever, and had no blood work done in relation to the synvisc-one injections.On an unknown date in (b)(6) 2018 (last week), the patient had some fluid drawn from both knees and sent for testing, and the test results came back ok.The patient stated she did not have any prosthetics.The patient stated she had not received immunosuppressants.The patient stated that her only chronic condition was sjogren's.The patient received the synvisc-one injections from supply on hand at the doctor's office, so she did not have information on storage.The patient stated that she might have had some numbing agent injected into her knees at the same time as synvisc-one.Corrective treatment: hydrocodone bitartrate/paracetamol (hydrocodone w/acetaminophen), ice, and elevation for device malfunction, could not put weight on either knee, couldn't walk, knee swelling, knee pain outcome: not recovered/not resolved for all the events seriousness criteria: important medical event for device malfunction a product technical complaint was initiated with the following results: 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 would be implemented.Pharmacovigilance comment: sanofi company comment dated: 27-feb-2018: this case concerns a female patient who received treatment with recalled lot of synvisc one and later had knee swelling, knee pain, cannot walk and couldn't put weight on either knee.Based upon the company investigation, the causal role of the product cannot be denied with the occurrence of event.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.
 
Event Description
This unsolicited case from united states was received on (b)(6) 2018 from a patient.This case involves a 64 year old female patient who received treatment with synvisc one and on the same day could not put weight on either knee, couldnot walk, knee swelling, knee pain.Also, device malfunction was identified for the reported lot number.No relevant past drugs were reported.Relevant medical history included surgery in 2005.Relevant concurrent conditions included sjogren's for which patient was being treated with hydroxychloroquine sulfate (plaquenil).The patient stated that she has no history of allergy to chicken, feathers, eggs, or other bird protein.Relevant concomitant medications included cetirizine hydrochloride (zyrtec) for environmental allergies, omeprazole (prilosec) for acid reflux, biotin for thin hair, losartan potassium for high blood pressure, hydroxychloroquine sulfate (plaquenil), sodium fluoride (dentagel) for sjogren's, nicotinic acid (niaspan) for high cholesterol, fluticasone propionate (flonase) for environmental allergies, ivermectin for rosacea, estradiol (vagifem) for dryness, olopatadine hydrochloride (patanol) for allergies, acetylsalicylic acid (aspirin), glucosamine, magnesium, fish oil (omega 3), ascorbic acid (vitamin c), curcuma longa rhizome (turmeric), calcium carbonate, colecalciferol (vitamin d3), montelukast (singulair), multiple vitamin tablet.On (b)(6) 2017, the patient received an injection of the recalled lot of synivsc-one, once (route: intraarticular; lot/batch number: 7rsl021; indication: not provided) in each knee for knee pain (batch has been recalled due to a microbial contamination).The patient stated that she had never received synvisc or synvisc- one before, prior to (b)(6) 2017.The same day, patient's both knees began swelling approximately 4 hours after the injection-the right was worse than the left.The same day, patient consulted healthcare professional regarding the problem.There was extreme pain (level 9-10).That same evening, the patient began to experience a lot of swelling and a lot of pain in both knees, she could not put weight on either knee, and she could not walk, and these symptoms persisted for several days before improving (pain and swelling continued but lessened after several days); then, on (b)(6) 2017, the pain, swelling, unable to bear weight on her knees, and inability to walk, started all over again.The patient stated that she had experienced pain and swelling in both knees off and on ever since then.On a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain, the patient estimated her knee pain at its worst, after the synivsc-one injections, as a 9.The pain and swelling worsened again after 12 days.The patient stated that the pain was severe enough that she was tempted to go to the emergency room, but she did not, and she stated she had not been hospitalized for her adverse knee symptoms.The patient stated that she called her doctor's office, and they asked if she had any pain medication around the house, which she did, so she treated her pain with some hydrocodone bitartrate/paracetamol (hydrocodone w/acetaminophen) 5/500 that she had left over from surgery in 2005, and the patient stated it was expired.The patient was currently treating her knee symptoms with some acetaminophen daily, ice, and elevation.The patient stated that she could not take naproxen because it increases her blood pressure.The patient stated that she engaged in no strenuous physical activities such as tennis or jogging after the synvisc-one injections.The patient stated that she had experienced no fever, and had no blood work done in relation to the synvisc-one injections.The patient again consulted the healthcare professional in person on (b)(6) 2017 and (b)(6) 2017.On an unknown date in feb-2018 (last week), the patient had some fluid drawn from both knees and sent for testing, and the test results came back ok.The patient stated she did not have any prosthetics.The patient stated she had not received immunosuppressants.The patient stated that her only chronic condition was sjogren's.The patient received the synvisc-one injections from supply on hand at the doctor's office, so she did not have information on storage.The patient stated that she might have had some numbing agent injected into her knees at the same time as synvisc-one.On (b)(6) 2018, tests were performed which included x-ray of both knee, body fluid differential, body fluid cell count, crystal exam, body fluid cell count with differential-no component into for this result and culture, wound and culture anaerobic.The same day, patient consulted healthcare professional in person and patient's fluid from both knee were taken to check for infection; the test came back ok.At 05:07 pm, patient's neutrophils, fluid was 9%, lymphocyte fluid was 20%, monocyte fluid was 63%, eosinophil fluid was 1%, mononuclear fluid was 7%, appearance was cloudy, wbc fluid was 653/mm3, rbc fluid was 19,050/mm3.The same day, at the time of report on (b)(6)2018, the patient still had intermittent swelling when walking or standing for a while.Corrective treatment: hydrocodone bitartrate/paracetamol (hydrocodone w/acetaminophen), ice, and elevation, physical therapy, paracetamol (tylenol), naproxen for device malfunction, could not put weight on either knee, couldnot walk, knee swelling, knee pain outcome: not recovered/not resolved for all the events seriousness criteria: important medical event for device malfunction a product technical complaint was initiated with global ptc number 52779 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 would be implemented.Follow up was received on 28-feb-2018.Global ptc number was added.Text was amended accordingly.Additional information was received on 30-mar-2018 from the patient.Indication of the suspect product was added.Corrective treatment of all the events was updated.Medical history, concurrent conditions and concomitant medications were added.Laboratory data was added.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated: 28-feb-2018: this case concerns a female patient who received treatment with recalled lot of synvisc one and later had knee swelling, knee pain, cannot walk and couldnot put weight on either knee.Based upon the company investigation, the causal role of the product cannot be denied with the occurrence of event.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.
 
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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 Key7324695
MDR Text Key101961758
Report Number2246315-2018-00358
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2018
Patient Sequence Number1
Treatment
ASPIRIN(CON.); BIOTIN(CON.); CALCIUM CARBONATE(CON.); DENTAGEL(CON.); FLONASE(CON.); GLUCOSAMINE(CON.); IVERMECTIN(CON.); LIPITOR(PREV.); LOSARTAN POTASSIUM(CON.); MAGNESIUM(CON.); NAPROXEN(PREV.); NIASPAN(CON.); OMEGA 3(CON.); PATANOL(CON.); PLAQUENIL(CON.); PLAQUENIL(CON.)-(ONGOING); PLAQUENIL(CON.)-(ONGOING); PRILOSEC(CON.); SINGULAIR(CON.); TURMERIC(CON.); VAGIFEM(CON.); VITAMIN C(CON.); VITAMIN D3(CON.); ZYRTEC(CON.)
Patient Outcome(s) Other;
Patient Age64 YR
Patient Weight66
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