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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 Erythema (1840); Pain (1994); Swelling (2091); Toxicity (2333); Disability (2371); Ambulation Difficulties (2544)
Event Date 11/01/2017
Event Type  malfunction  
Event Description
This case is cross referenced with case: (b)(4) (cluster). This unsolicited case from united states was received on (b)(6) 2017 (additional information received on 14- dec-2017, both processed together with the clock start date of (b)(6) 2017) from a patient. This case concerns a (b)(6) male patient who received treatment with synvisc one and on the same day had used crutches, had extreme pain, knee was swollen, swelling of the knee; later after unknown latency could hardly get around, took tylenol to help him sleep, knee red, knee was stiff and knee hot. Also device malfunction was identified for the reported lot number. No past drug was provided. He had synvisc one injections before (but never experienced any ae before; no complaints with these injections) on ((b)(6) 2017, (b)(6) 2016, (b)(6) 2016, (b)(6) 2015, (b)(6) 2015). Concomitant medications include metoprolol tartrate (lopressor) and hydrochlorothiazide (hydrochlorot) for hypertension; atorvastatin calcium (lipitor) for cholesterol. Patient had medical history of dyslipidemia, glaucoma, peripheral vascular disease and left proximal humero fracture. Patient had no allergies on (b)(6) 2017 (a month ago), the patient initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml for osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020) into the right knee. On the same day, immediately after injection, the patient had swelling/ swelling of the knee and extreme pain. Patient used crutches for 3 days. On an unknown date in (b)(6) 2017, after unknown latency patient was red and hot. Patient did not engage in activities such as jogging or tennis soon after the injection. It was reported that the patient didn't even drive back home. His wife drove him back home. It was reported that the patient had to take paracetamol (tylenol), rest in the chair and had to put non-stop ice. On an unknown date in (b)(6) 2017, after unknown latency, the patient could hardly get around, his knee was swollen and stiff, but no fever chills redness or drainage. It was reported that the patient has been icing and elevating the affected knee and took paracetamol pm to help him sleep. The doctor's notes report that the knee was stiff and swollen, and recommended to continue with ice and elevation, nsaids and paracetamol. The patient had not come back in, but someone from the office spoke with him and he reported that his knee was still swollen, but he has had no fevers, or systemic symptoms. It was reported that as per the doctor's notes they were going to "start with esr/crp and will aspirate if symptoms warrant" during the patient's next visit. Patient did consulted hcp by telephone and was not admitted to hospital. On (b)(6) 2017, patient had lab test: crp (c-reactive protein) was less than 0. 5. The patient reported that she did not get the results she had from past injection. Corrective treatment: ice, elevation; nsaids and paracetamol for can hardly get around, knee red, knee is swollen, swelling of the knee, knee is stiff, extreme pain and knee hot; paracetamol for took tylenol to help him sleep. Outcome: not recovered for device malfunction, knee is swollen; unknown for rest of the events a global pharmaceutical technical complaint was initiated with 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: disability for used crutches and for device malfunction follow up was received on 21-dec-2017. No new information was received. Additional information was received on 09-jan-2018. The global ptc number was added. Text amended accordingly. Additional information was received on 15-jan-2018. Verbatim was updated for the event of knee is swollen to knee is swollen, swelling of the knee. Onset date was updated for the events of knee is swollen, swelling of the knee and extreme pain; latency too. Event of used crutches was added along with its details. Concomitant medications and medical history added. Clinical course was updated and text amended accordingly additional information was receive on 18-jan-2018 from the patient's wife. Symptom of did not get the results i've had from past injection was added. Information on concomitant medications was added. Clinical course was updated and text amended accordingly pharmacovigilance comment: sanofi company comment for follow- up dated 22-jan-2018: the additional information does not alter the previous case assessment. This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced walking difficulty, right knee swelling, stiffness and poor quality sleep. Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out with the product administration. In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.
 
Event Description
This case is cross referenced with case: (b)(4). This unsolicited case from united states was received on 12-dec-2017 (additional information received on 14- dec-2017, both processed together with the clock start date of 12-dec-2017) from a patient. This case concerns a (b)(6) years old male patient who received treatment with synvisc one and on the same day had used crutches, had had extreme pain, knee was swollen, swelling of the knee; later after unknown latency could hardly get around, took tylenol to help him sleep, knee red, knee was stiff and knee hot. Also device malfunction was identified for the reported lot number. No past drug was provided. He had synvisc one injections before (but never experienced any ae before; no complaints with these injections) on ((b)(6) 2017, (b)(6) 2016, (b)(6) 2016, (b)(6) 2015, (b)(6) 2015). Concomitant medications include metoprolol tartrate (lopressor) and hydrochlorothiazide for hypertension; atorvastatin calcium (lipitor) for cholesterol. Patient had medical history of dyslipidemia, glaucoma, peripheral vascular disease and left proximal humero fracture. Patient had no allergies on (b)(6) 2017 (a month ago), the patient initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml for osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020) into the right knee. On the same day, immediately after injection, the patient had swelling/ swelling of the knee and extreme pain. Patient used crutches for 3 days. On an unknown date in (b)(6) 2017, after unknown latency patient was red and hot. Patient did not engage in activities such as jogging or tennis soon after the injection. It was reported that the patient didn't even drive back home. His wife drove him back home. It was reported that the patient had to take paracetamol (tylenol), rest in the chair and had to put non-stop ice. On an unknown date in (b)(6) 2017, after unknown latency, the patient could hardly get around, his knee was swollen and stiff, but no fever chills redness or drainage. It was reported that the patient has been icing and elevating the affected knee and took paracetamol pm to help him sleep. The doctor's notes report that the knee was stiff and swollen, and recommended to continue with ice and elevation, nsaids and paracetamol. The patient had not come back in, but someone from the office spoke with him and he reported that his knee was still swollen, but he has had no fevers, or systemic symptoms. It was reported that as per the doctor's notes they were going to "start with esr/crp and will aspirate if symptoms warrant" during the patient's next visit. Patient did consulted hcp by telephone and was not admitted to hospital. On (b)(6) 2017, patient had lab test: crp (c-reactive protein) was less than 0. 5. Corrective treatment: ice, elevation; nsaids and paracetamol for can hardly get around, knee red, knee is swollen, swelling of the knee, knee is stiff, extreme pain and knee hot; paracetamol for took tylenol to help him sleep. Outcome: not recovered for device malfunction, knee is swollen; unknown for rest of the events a global pharmaceutical technical complaint was initiated with 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: disability for used crutches and for device malfunction follow up was received on 21-dec-2017. No new information was received. Additional information was received on 09-jan-2018. The global ptc number was added. Text amended accordingly. Additional information was received on 15-jan-2018. Verbatim was updated for the event of knee is swollen to knee is swollen, swelling of the knee. Onset date was updated for the events of knee is swollen, swelling of the knee and extreme pain; latency too. Event of used crutches was added along with its details. Concomitant medications and medical history added. Clinical course was updated and text amended accordingly pharmacovigilance comment: sanofi company comment for follow- up dated 15-jan-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced walking difficulty, right knee swelling, stiffness and poor quality sleep. Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out with the product administration. In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.
 
Event Description
Based on additional information received on 29-jan- 2018, this case became medically confirmed. This case is cross referenced with case: (b)(4) (cluster). This unsolicited case from united states was received on 12-dec-2017 (additional information received on 14- dec-2017, both processed together with the clock start date of 12-dec-2017) from a patient. This case concerns a (b)(6) years old male patient who received treatment with synvisc one and on the same day had used crutches, had had knee was stiff, extreme pain, knee was swollen, swelling of the knee; later after unknown latency could hardly get around, took tylenol to help him sleep, knee red and knee hot. Also device malfunction was identified for the reported lot number. No past drug was provided. He had synvisc one injections before (but never experienced any ae before; no complaints with these injections) on ((b)(6) 2017, (b)(6) 2016, (b)(6) 2016, (b)(6) 2015, (b)(6) 2015; the patient had been receiving synvisc one every 06 months since 2014 without any adverse results). Concomitant medications include metoprolol tartrate (lopressor) and hydrochlorothiazide (hydrochlorot) for hypertension; atorvastatin calcium (lipitor) for cholesterol, dorzolamide hydrochloride/timolol maleate (cosopt), latanoprost (xalatan), brimonidine tartrate (alphagan) for glaucoma. Patient had medical history of dyslipidemia, peripheral vascular disease and left proximal humero fracture. Patient had no allergies on (b)(6) 2017 (a month ago), the patient initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml for osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020) into the right knee. On the same day, immediately after injection, the patient had stiffness, swelling/ swelling of the knee and extreme pain. Patient used crutches for 3 days. On an unknown date in (b)(6) 2017, after unknown latency patient was red and hot. Patient did not engage in activities such as jogging or tennis soon after the injection. It was reported that the patient didn't even drive back home. His wife drove him back home. It was reported that the patient had to take paracetamol (tylenol), rest in the chair and had to put non-stop ice. On an unknown date in (b)(6) 2017, after unknown latency, the patient could hardly get around, his knee was swollen and stiff, but no fever chills redness or drainage. It was reported that the patient has been icing and elevating the affected knee and took paracetamol pm to help him sleep. The doctor's notes report that the knee was stiff and swollen, and recommended to continue with ice and elevation, nsaids and paracetamol. The patient had not come back in, but someone from the office spoke with him and he reported that his knee was still swollen, but he has had no fevers, or systemic symptoms. It was reported that as per the doctor's notes they were going to "start with esr/crp and will aspirate if symptoms warrant" during the patient's next visit. Patient did consulted hcp by telephone and was not admitted to hospital. On (b)(6) 2017, patient had lab test: crp (c-reactive protein) was less than 0. 5 and erythrocyte sedimentation rate was1; units and reference range not provided). The patient reported that she did not get the results she had from past injection. The patient had lessened effectiveness of product. Corrective treatment: ice, elevation; nsaids and paracetamol for can hardly get around, knee red, knee is swollen, swelling of the knee, knee is stiff, extreme pain and knee hot; paracetamol for took tylenol to help him sleep. Outcome: not recovered for device malfunction, knee is swollen,swelling of the knee, extreme pain, knee is stiff; unknown for rest of the events a global pharmaceutical technical complaint was initiated with 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: disability for used crutches and for device malfunction follow up was received on 21-dec-2017. No new information was received. Additional information was received on 09-jan-2018. The global ptc number was added. Text amended accordingly. Additional information was received on 15-jan-2018. Verbatim was updated for the event of knee is swollen to knee is swollen, swelling of the knee. Onset date was updated for the events of knee is swollen, swelling of the knee and extreme pain; latency too. Event of used crutches was added along with its details. Concomitant medications and medical history added. Clinical course was updated and text amended accordingly additional information was receive on 18-jan-2018 from the patient's wife. Symptom of did not get the results i've had from past injection was added. Information on concomitant medications was added. Clinical course was updated and text amended accordingly. Additional information was received on 29-jan-2018 from medical doctor. Additional concomitant medications were added. The event start date of knee is stiff was updated and outcome was updated from unknown to not recovered. Clinical course was updated. Text amended accordingly. Pharmacovigilance comment: sanofi company comment for follow- up dated 29-jan-2018: the additional information does not alter the previous case assessment. This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced walking difficulty, right knee swelling, stiffness and poor quality sleep. Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out with the product administration. In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.
 
Event Description
This case is cross referenced with case: (b)(4) (cluster). This unsolicited case from united states was received on 12-dec-2017 (additional information received on 14-dec-2017, both processed together with the clock start date of 12-dec-2017) from a patient. This case concerns a (b)(6) male patient who received treatment with synvisc one and later after unknown latency could hardly get around, took tylenol to help him sleep, knee red, knee was swollen, knee was stiff, had extreme pain and knee hot. Also device malfunction was identified for the reported lot number. No past drug, medical history, concomitant medication or concurrent condition was provided. He had synvisc one injections before (but never experienced any ae before; no complaints with these injections) on ((b)(6) 2017, (b)(6) 2016, (b)(6) 2015). On (b)(6) 2017 (a month ago), the patient initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown) into the right knee. On an unknown date in (b)(6) 2017, after unknown latency (immediately after injection) the patient had swelling and extreme pain. It was red and hot. He did not engage in activities such as jogging or tennis soon after the injection. It was reported that the patient didn't even drive back home. His wife drove him back home. It was reported that the patient had to take paracetamol (tylenol), rest in the chair and had to put nonstop ice. On an unknown date in (b)(6) 2017, after unknown latency, the patient could hardly get around, his knee was swollen and stiff, but no fever chills redness or drainage. It was reported that the patient has been icing and elevating the affected knee and took paracetamol pm to help him sleep. The doctor's notes report that the knee was stiff and swollen, and recommended to continue with ice and elevation, nsaids and paracetamol. The patient had not come back in, but someone from the office spoke with him and he reported that his knee was still swollen, but he has had no fevers, or systemic symptoms. It was reported that as per the doctor's notes they were going to "start with esr/crp and will aspirate if symptoms warrant" during the patient's next visit. Corrective treatment: ice, elevation; nsaids and paracetamol for can hardly get around, knee red, knee is swollen, knee is stiff, extreme pain and knee hot; paracetamol for took tylenol to help him sleep. Outcome: not recovered for device malfunction, knee is swollen; unknown for rest of the 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 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 12-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced walking difficulty, right knee swelling, stiffness and poor quality sleep. Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out with the product administration. In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
MDR Report Key7170635
MDR Text Key279108718
Report Number2246315-2017-00379
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,health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/29/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 01/07/2018 Patient Sequence Number: 1
Treatment
ALPHAGAN(CON.); COSOPT(CON.); HYDROCHLOROT(CON.) -START; HYDROCHLOROT(CON.) -START; HYDROCHLOROT(CON.) -STOP UNKNOWN; HYDROCHLOROT(CON.) -STOP UNKNOWN; HYDROCHLOROTHIAZIDE(CON.); LIPITOR(CON.)-START; LIPITOR(CON.)-START; LIPITOR(CON.)-START; LIPITOR(CON.)-STOP UNKNOWN; LIPITOR(CON.)-STOP UNKNOWN; LIPITOR(CON.)-STOP UNKNOWN; LOPRESSOR(CON.); LOPRESSOR(CON.) -START; LOPRESSOR(CON.) -START; LOPRESSOR(CON.) -STOP UNKNOWN; LOPRESSOR(CON.) -STOP UNKNOWN; SYNVISC ONE(PREV.)-START; SYNVISC ONE(PREV.)-START; SYNVISC ONE(PREV.)-START; SYNVISC ONE(PREV.)-START; SYNVISC ONE(PREV.)-STOP UNKNOWN; SYNVISC ONE(PREV.)-STOP UNKNOWN; SYNVISC ONE(PREV.)-STOP UNKNOWN; XALATAN(CON.)
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