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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ
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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Erythema (1840); Fall (1848); Pain (1994); Burning Sensation (2146); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Shaking/Tremors (2515); No Code Available (3191)
Event Date 11/17/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 22-jan-2018 from a patient.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and had trouble getting out of the car/could not get out of the car, bad pain in the right leg, swelling, redness, burning sensation and it was still stiff/stiffness in her right knee on the same day and after unknown latency had knot behind her leg, after 34 days fell.No medical history, concomitant medication and concurrent condition was provided.Patient had received synvisc one in left knee in (b)(6) 2017 and had no problems.Patient had no known drug allergies.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided) in right knee for osteoarthritis.On the same day, patient had trouble getting out of the car when she was getting home from the injection and could not get out of the car.On the same day, patient was having bad pain in the right leg.It was reported that after the right knee injection patient had bad pain in right leg, swelling, redness and burning sensation on the same day.Patient followed up with the doctor and had a knot behind her leg (onset date and latency: unknown).The knee was still stiff but the swelling, burning and redness had resolved.Patient was initially told to go to the emergency room (er) but did not go as she provided self care of alternating heat and ice.Patient did not take medication for the pain and was healthy other than her knees.On (b)(6) 2018, 34 days after the injection, patient fell due to the stiffness in her right knee.Also reported that there was no measurement of the knee prior to injection.Corrective treatment: alternating heat and ice for bad pain in the right leg, swelling, redness, burning sensation and it is still stiff/stiffness in her right knee and not reported for other events except device malfunction.Outcome: recovered for swelling, redness, burning sensation and unknown for other events 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.Seriousness criteria: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 27-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced mobility decreased, right leg pain, swelling, burning sensation and redness.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 products cannot be excluded.
 
Event Description
This unsolicited case from united states was received on 22-jan-2018 from a patient.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and had trouble getting out of the car/could not get out of the car, bad pain in the right leg, swelling, redness, had intense pain, burning sensation, had more difficulty walking and it was still stiff/stiffness in her right knee on the same day and after unknown latency had knot behind her leg/have a knot behind my knees, after 64 days fell.No medical history and concurrent condition was provided.Patient had received synvisc one in left knee in (b)(6) 2017 and had no problems.Patient had no known drug allergies.Patient was taking naproxen sodium (aleve) on (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided) in right knee for osteoarthritis.On the same day, patient had trouble getting out of the car when she was getting home from the injection and could not get out of the car.Patient developed intense pain, shaking, stiffness burning, had more difficulty walking.On the same day, patient was having bad pain in the right leg.It was reported that after the right knee injection patient had bad pain in right leg, swelling, redness and burning sensation on the same day.Patient followed up with the doctor and had a knot behind her leg (onset date and latency: unknown).The knee was still stiff but the swelling, burning and redness had resolved.Patient was initially told to go to the emergency room (er) but did not go as she provided self care of alternating heat and ice.Patient did not take medication for the pain and was healthy other than her knees.On (b)(6) 2018, 34 days after the injection, patient fell due to the stiffness in her right knee.Also reported that there was no measurement of the knee prior to injection.Corrective treatment: alternating heat and ice for bad pain in the right leg, swelling, redness, burning sensation and it is still stiff/stiffness in her right knee and not reported for other events except device malfunction.Outcome: recovered for swelling, redness, burning sensation and unknown for other events 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.Seriousness criteria: important medical event for device malfunction.Additional information was received on 13-feb-2018 from the patient.Event of more difficulty walking and intense pain were added.Concomitant medication was added.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 13-feb-2018:the follow up information received does not change the previous case assessment.This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced mobility decreased, right leg pain, swelling, burning sensation and redness.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 products cannot be excluded.
 
Event Description
Device malfunction [device malfunction].Trouble getting out of the car/could not get out of the car.[mobility decreased].Bad pain in the right leg [unilateral leg pain].Swelling [leg edema].Redness [redness of legs].Burning sensation [extremities burning sensation of].Shaking [shaking].More difficulty walking [difficulty in walking].Knot behind her leg/have a knot behind my knees [mass].Fell [fall].It is still stiff/stiffness in her right knee/stiffness [joint stiffness].Intense pain/right knee pain [knee pain].Case narrative: this unsolicited legal case from united states was received on (b)(6) 2018 from a patient.This case concerns a 74 years old female patient who received treatment with synvisc one injection and had trouble getting out of the car/could not get out of the car, bad pain in the right leg, swelling, redness, had intense pain/right knee pain, burning sensation, had more difficulty walking, and it was still stiff/stiffness in her right knee on the same day and after unknown latency had knot behind her leg/have a knot behind my knees, after 64 days fell.Medical history included bone-on-bone osteoarthritis, arthritis, broken bones, hemorrhoids, limb swelling, migraine, primary osteoarthritis of both knees, rheumatic fever.Patient had received synvisc one in left knee in (b)(6) 2017 and had no problems.Patient had no known drug allergies.Patient was taking naproxen sodium (aleve) for osteoarthritic pain, vitamin d2, diclofenac (voltaren).Family history included diabetes, unspecified type.Currently patient was an alcohol user and was a former tobacco user.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: may-2020) in right knee for primary osteoarthritis of right knee.It was reported that the patient had a little bit of reaction to synvisc one.On the same day, patient had trouble getting out of the car when she was getting home from the injection and could not get out of the car.Patient developed intense pain, shaking, stiffness burning, had more difficulty walking.On the same day, patient was having bad pain in the right leg.It was reported that after the right knee injection patient had bad pain in right leg, swelling, redness, and burning sensation on the same day.Patient followed up with the doctor and had a knot behind her leg (onset date and latency: unknown).The knee was still stiff but the swelling, burning and redness had resolved.Patient was initially told to go to the emergency room (er) but did not go as she provided self-care of alternating heat and ice.Patient did not take medication for the pain and was healthy other than her knees.On (b)(6) 2017, patient went for evaluation of right knee.Also reported that the patient was doing a lot better.Patient used some home remedies and got the swelling down and calmed it down.On (b)(6) 2018, 34 days after the injection, patient fell due to the stiffness in her right knee.Also reported that there was no measurement of the knee prior to injection.On (b)(6) 2018, patient had follow up visit for right knee pain.On the same day, patient had discussion regarding the surgery and the implant type used during surgery.Corrective treatment: alternating heat and ice for bad pain in the right leg, swelling, redness, burning sensation, and it is still stiff/stiffness in her right knee and not reported for other events except device malfunction.Outcome: recovered for swelling, redness, burning sensation; recovering for it is still stiff/stiffness in her right knee/stiffness, intense pain/right knee pain and unknown for other events.A product technical complaint was initiated on (b)(6) 2018 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: medically significant for device malfunction.Additional information was received on (b)(6) 2018 from the patient.Event of more difficulty walking and intense pain were added.Concomitant medication was added.Clinical course was updated and text amended accordingly.Follow up was received on 22-feb-2018.No new information was received.Additional information was received on 16-jan-2019 from a lawyer.Report type was updated to legal.Patient's medical history and concomitant medications were added.Expiry date of synvisc one was added and indication was updated.Outcome of still stiff/stiffness in her right knee/stiffness, intense pain/right knee pain was updated from not recovered to recovering.Clinical course was updated and text amended accordingly.
 
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Brand Name
SYNVISC ONE
Type of Device
MOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
MDR Report Key7250658
MDR Text Key99303629
Report Number2246315-2018-00247
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,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/01/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALEVE (NAPROXEN SODIUM),UNKNOWN; ALEVE(CON.); SYNVISC ONE(PREV.) - START; SYNVISC ONE(PREV.) - START; SYNVISC ONE(PREV.) - STOP; SYNVISC ONE(PREV.) - STOP; VITAMIN D2 (VITAMIN D2),CAPSULE; VOLTAREN [DICLOFENAC] (DICLOFENAC),GEL; SYNVISC ONE(PREV.) - START; SYNVISC ONE(PREV.) - STOP
Patient Outcome(s) Other;
Patient Age74 YR
Patient Weight66
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