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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
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Nausea (1970); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Cramp(s) (2193); Myalgia (2238); Arthralgia (2355); Joint Disorder (2373); Reaction (2414)
Event Date 04/01/2016
Event Type  Injury  
Event Description
This unsolicited device case from united states was received on 04-may-2016 from a patient. This case involves a male patient who experienced inflammation, leg cramps and nausea and was unable to bend knee/could not bend it past 20 degrees after receiving treatment with synvisc one. The patient had been getting synvisc one injections approximately every 6 months and did not have any problems with previous injections. No medical history, concomitant medication or concurrent condition was reported. On (b)(6) 2016, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/ lot number and expiration date: not provided) into right knee for knee pain. On an unknown date in (b)(6) 2016, after the injection, the patient developed severe pain, incredible swelling, stiffness, nausea, leg cramps, joint pain in shoulders and back, and was unable to bend his knee. It was reported that the symptoms started out gradually and progressively got worse and worse. On an unknown date in (b)(6) 2016, 8 days after the injection, the leg cramps started and were very painful. By last weekend, the leg was so swollen and was the size of his upper thigh. The patient could not bend the leg past 20 degrees. It was reported that the patient had nearly been hospitalized twice in the past 19 days since the injection so that was a very serious reaction and he was not happy. On (b)(6) 2016, the patient saw the physician who told him that there was nothing that he could do for the reaction. It was reported that the physician said that he could not remove any fluid from the knee, but did give him prescription for 6-day pack of oral steroids to help with inflammation. The swelling went down significantly since the patient started the steroids. The patient was also taking turmeric root, icing the knee, and wearing a compression stocking to help facilitate his knee returning to normal. The patient found lots of information online about that type of reaction occurring in patients who had multiple injections, specifically patients who had more than 5 injections in the past. Corrective treatment: oral steroids, turmeric root, icing, wearing compression stocking for inflammation and unable to bend knee/could not bend it past 20 degrees; not reported for rest of the events. Outcome: recovering for inflammation, unknown for rest of the events. A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending. Seriousness criterion: required intervention for inflammation and unable to bend knee/could not bend it past 20 degrees. Pharmacovigilance comment: sanofi company comment dated 9-may-2016: this case concerns a patient who reported receiving synvisc one in right knee and later experienced inflammation characterized by pain, swelling, stiffness and arthralgia. Based upon the positive temporal relationship and the nature of the events the causal role of product in the occurrence of the events cannot be denied. However, the lack of information regarding patient's underlying condition that led to knee pain for which the patient received synvisc one, technique of the injection and other predisposing factors is required to make complete case assessment. Also, since the patient had tolerated the synvisc one injections in the past a detailed explanation of the adverse events along with complete etiology is required for a comprehensive case assessment.
 
Event Description
This unsolicited device case from united states was received on 04-may-2016 from a patient. This case involves a male patient who experienced inflammation, leg cramps and nausea and was unable to bend knee/could not bend it past 20 degrees after receiving treatment with synvisc one. The patient had been getting synvisc one injections approximately every 6 months and did not have any problems with previous injections. No medical history, concomitant medication or concurrent condition was reported. On (b)(6)-2016, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/ lot number and expiration date: not provided) into right knee for knee pain. On an unknown date in (b)(6)-2016, after the injection, the patient developed severe pain, incredible swelling, stiffness, nausea, leg cramps, joint pain in shoulders and back, and was unable to bend his knee. It was reported that the symptoms started out gradually and progressively got worse and worse. On an unknown date in (b)(6)-2016, 8 days after the injection, the leg cramps started and were very painful. By last weekend, the leg was so swollen and was the size of his upper thigh. The patient could not bend the leg past 20 degrees. It was reported that the patient had nearly been hospitalized twice in the past 19 days since the injection so that was a very serious reaction and he was not happy. On (b)(6)-2016, the patient saw the physician who told him that there was nothing that he could do for the reaction. It was reported that the physician said that he could not remove any fluid from the knee, but did give him prescription for 6-day pack of oral steroids to help with inflammation. The swelling went down significantly since the patient started the steroids. The patient was also taking turmeric root, icing the knee, and wearing a compression stocking to help facilitate his knee returning to normal. The patient found lots of information online about that type of reaction occurring in patients who had multiple injections, specifically patients who had more than 5 injections in the past. Corrective treatment: oral steroids, turmeric root, icing, wearing compression stocking for inflammation and unable to bend knee/could not bend it past 20 degrees; not reported for rest of the events outcome: recovering for inflammation, unknown for rest of the events (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr process. Sanofi genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. Sanofi genzyme biosurgery would continue to monitor adverse events to determine if a capa was required. Seriousness criterion: required intervention for inflammation and unable to bend knee/could not bend it past 20 degrees. Additional information was received on 17-may-2016. Global ptc number and ptc results were added. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 17-may-2016: the follow up information received does not change the overall case assessment. Sanofi company comment dated 9-may-2016: this case concerns a patient who reported receiving synvisc one in right knee and later experienced inflammation characterized by pain, swelling, stiffness and arthralgia. Based upon the positive temporal relationship and the nature of the events the causal role of product in the occurrence of the events cannot be denied. However, the lack of information regarding patient's underlying condition that led to knee pain for which the patient received synvisc one, technique of the injection and other predisposing factors is required to make complete case assessment. Also, since the patient had tolerated the synvisc one injections in the past a detailed explanation of the adverse events along with complete etiology is required for a comprehensive case assessment.
 
Event Description
This unsolicited device case from united states was received on 04-may-2016 from a patient. This case involves a male patient of unknown age who experienced inflammation, leg cramps, immobility and nausea and was unable to bend knee/could not bend it past 20 degrees after receiving treatment with synvisc one and eight weeks after his last injection of synvisc one, he had only improved about 40%/still has lingering pain (therapeutic response decreased). The patient had been getting synvisc one injections approximately every 6 months and did not have any problems with previous injections. No medical history, concomitant medication or concurrent condition was reported. On (b)(6) 2016, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/ lot number and expiration date: not provided) into right knee for knee pain. On an unknown date in (b)(6) 2016, after the injection, the patient developed severe pain, incredible swelling, stiffness, nausea, leg cramps, joint pain in shoulders and back, and was unable to bend his knee. It was reported that the symptoms started out gradually and progressively got worse and worse. On an unknown date in (b)(6) 2016, 8 days after the injection, the leg cramps started and were very painful. By last weekend, the leg was so swollen and was the size of his upper thigh. The patient could not bend the leg past 20 degrees. It was reported that the patient had nearly been hospitalized twice in the past 19 days since the injection so that was a very serious reaction and he was not happy. On (b)(6) 2016, the patient saw the physician who told him that there was nothing that he could do for the reaction. It was reported that the physician said that he could not remove any fluid from the knee, but did give him prescription for 6-day pack of oral steroids to help with inflammation. The swelling went down significantly since the patient started the steroids. The patient was also taking turmeric root, icing the knee, and wearing a compression stocking to help facilitate his knee returning to normal. The patient found lots of information online about that type of reaction occurring in patients who had multiple injections, specifically patients who had more than 5 injections in the past. On an unknown date in 2016, eight weeks after his last injection of synvisc one, the patient had only improved about 40% (therapeutic response decreased). The patient still had lingering pain, immobility and a feeling of fullness in his knee. It was reported that his doctor did not know what to do and just kept telling him that he would get better. The patient was angry because his doctor "sold" him the injections. Corrective treatment: oral steroids, turmeric root, icing, wearing compression stocking for inflammation and unable to bend knee/could not bend it past 20 degrees; not reported for leg cramps, nausea, immobility outcome: recovering for inflammation; not recovered for immobility; unknown for unable to bend knee/could not bend it past 20 degrees, leg cramps, nausea (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr process. Sanofi genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. Sanofi genzyme biosurgery would continue to monitor adverse events to determine if a capa was required. Seriousness criterion: required intervention for inflammation and unable to bend knee/could not bend it past 20 degrees additional information was received on 17-may-2016. Global ptc number and ptc results were added. Text was amended accordingly. Additional information was received on 10-jun-2016. The events of immobility and eight weeks after his last injection of synvisc one, he has only improved about 40%/still has lingering pain (therapeutic response decreased) were added with details. The verbatim for the symptom of stiffness was updated to stiffness/feeling of fullness in knee. Clinical course updated and text amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 10-jun-2016: the follow up information received does not change the overall case assessment. Sanofi company comment dated 9-may-2016: this case concerns a patient who reported receiving synvisc one in right knee and later experienced inflammation characterized by pain, swelling, stiffness and arthralgia. Based upon the positive temporal relationship and the nature of the events the causal role of product in the occurrence of the events cannot be denied. However, the lack of information regarding patient's underlying condition that led to knee pain for which the patient received synvisc one, technique of the injection and other predisposing factors is required to make complete case assessment. Also, since the patient had tolerated the synvisc one injections in the past a detailed explanation of the adverse events along with complete etiology is required for a comprehensive case assessment.
 
Event Description
This unsolicited device case from united states was received on 04-may-2016 from a patient. This case involves a male patient of unknown age who experienced inflammation, was unable to bend knee/could not bend it past 20 degrees, had leg cramps, nausea, immobility/makes him, feel crippled, leg was swollen it was the size of his upper thigh and eight weeks after his last injection of synvisc one, he has only improved about 40%/still has lingering pain (therapeutic response decreased). The patient had been getting synvisc one injections approximately every 6 months and did not have any problems with previous injections. No medical history, concomitant medication or concurrent condition was reported. On (b)(6) 2016, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/ lot number and expiration date: not provided) into right knee for knee pain. On an unknown date in (b)(6) 2016, after the injection, the patient developed severe pain, incredible swelling, stiffness, nausea, leg cramps, joint pain in shoulders and back, and was unable to bend his knee. It was reported that the symptoms started out gradually and progressively got worse and worse. On an unknown date in (b)(6) 2016, 8 days after the injection, the leg cramps started and were very painful. By last weekend, the leg was so swollen and was the size of his upper thigh. The patient could not bend the leg past 20 degrees. It was reported that the patient had nearly been hospitalized twice in the past 19 days since the injection so that was a very serious reaction and he was not happy. On (b)(6) 2016, the patient saw the physician who told him that there was nothing that he could do for the reaction. It was reported that the physician said that he could not remove any fluid from the knee, but did give him prescription for 6-day pack of oral steroids to help with inflammation. The swelling went down significantly since the patient started the steroids. The patient was also taking turmeric root, icing the knee, and wearing a compression stocking to help facilitate his knee returning to normal. The patient found lots of information online about that type of reaction occurring in patients who had multiple injections, specifically patients who had more than 5 injections in the past. On an unknown date in 2016, eight weeks after his last injection of synvisc one, the patient had only improved about 40% (therapeutic response decreased). The patient still had lingering pain, immobility and a feeling of fullness in his knee. It was reported that his doctor did not know what to do and just kept telling him that he would get better. The patient was angry because his doctor "sold" him the injections. It was reported that in all injections prior to 6th injection, the patient felt fine. It was reported that last synvisc one injection made the patient felt crippled and in pain all the time. It was reported that the patient felt like a little person in his knee banging with a hammer. Corrective treatment: oral steroids, turmeric root, icing, wearing compression stocking for inflammation and unable to bend knee/could not bend it past 20 degrees; not reported for leg cramps, nausea, unknown for immobility/makes him feel crippled and leg was swollen it was the size of his upper thigh. Outcome: recovering for inflammation; not recovered for immobility/makes him feel crippled; unknown for leg was swollen it was the size of his upper thigh, unable to bend knee/could not bend it past 20 degrees, leg cramps, nausea. A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr process. Sanofi genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. Sanofi genzyme biosurgery would continue to monitor adverse events to determine if a capa was required. Seriousness criterion: required intervention for inflammation and unable to bend knee/could not bend it past 20 degrees. Additional information was received on 17-may-2016. Global ptc number and ptc results were added. Text was amended accordingly. Additional information was received on 10-jun-2016. The events of immobility and eight weeks after his last injection of synvisc one, he has only improved about 40%/still has lingering pain (therapeutic response decreased) were added with details. The verbatim for the symptom of stiffness was updated to stiffness/feeling of fullness in knee. Clinical course updated and text amended accordingly. Additional information was received on 13-jun-2016 from the patient. The linking term for the event of inflammation was updated from inflammation to joint inflammation. The verbatim of symptom of "severe pain" was updated to "severe pain/feels like a little person is in his knee banging with a hammer"and of the symptom of "incredible swelling/leg was swollen it was the size of his upper thigh" was updated to "incredible swelling". The event of "leg was swollen it was the size of his upper thigh" was added. Clinical course updated and text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 13-jun-2016: the follow up information received does not change the overall case assessment. Sanofi company comment dated 9-may-2016: this case concerns a patient who reported receiving synvisc one in right knee and later experienced inflammation characterized by pain, swelling, stiffness and arthralgia. Based upon the positive temporal relationship and the nature of the events the causal role of product in the occurrence of the events cannot be denied. However, the lack of information regarding patient's underlying condition that led to knee pain for which the patient received synvisc one, technique of the injection and other predisposing factors is required to make complete case assessment. Also, since the patient had tolerated the synvisc one injections in the past a detailed explanation of the adverse events along with complete etiology is required for a comprehensive case assessment.
 
Event Description
This case was cross referenced with case: (b)(4) (duplicate). This unsolicited device case from united states was received on 04-may-2016 from a patient. This case involves a (b)(6) male patient who received treatment with synvisc one and after few days experienced occasional numbness of the upper back and trunk muscles, generalized muscle pain, inflammation, was unable to bend knee/could not bend it past 20 degrees, had leg cramps, nausea, immobility/makes him feel crippled, leg was swollen it was the size of his upper thigh and eight weeks after his last injection of synvisc one, he had only improved about 40%/still had lingering pain (therapeutic response decreased). The patient had anterior cruciate ligament (acl) repair of his right knee 25 years ago at which time he was informed of significant cartilage damage/loss. Even with a relatively active lifestyle and avoidance of impact activities such as running and basketball, the knee was predominantly asymptomatic. By 2. 5 years ago, he began experiencing right knee pain and sought care from a local orthopedic/sports group who felt the previous knee problems were causing the discomfort. The patient had been getting synvisc one injections approximately every 6 months following recurrence of the knee pain which went well with excellent results and the patient did not have any problem with previous injections. No concomitant medication or concurrent condition was reported. On (b)(6) 2016, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/ lot number and expiration date: not provided) into right knee for knee pain. On unknown dates in (b)(6) 2016, after unknown latency, the patient developed increased pain and fullness of the affected knee, inability to walk well followed a week later by some generalized muscle pain and occasional numbness of the upper back and trunk muscles. The patient also had severe pain, incredible swelling, stiffness, nausea, leg cramps, joint pain in shoulders and back, and was unable to bend his knee. It was reported that the symptoms started out gradually and progressively got worse and worse. On an unknown date in (b)(6) 2016, 8 days after the injection, the leg cramps started and were very painful. By last weekend, the leg was so swollen and was the size of his upper thigh. The patient could not bend the leg past 20 degrees. It was reported that the patient had nearly been hospitalized twice in the past 19 days since the injection so that was a very serious reaction and he was not happy. On (b)(6) 2016, the patient saw the physician who told him that there was nothing that he could do for the reaction. It was reported that the physician said that he could not remove any fluid from the knee, but did give him prescription for 6-day pack of oral steroids to help with inflammation. The orthopedist prescribed methylprednisolone (medrol dosepak) without relief and supposedly did not offer any further explanation or further treatment advice other than return when the patient agreed to knee replacement. The patient refused surgery and was convinced the current knee problem and additional muscle issues which continued to the present were an allergic reaction to the injection. It was reported that the allergic reaction was not a likely cause and that the affected knee had deteriorated enough that bone-on-bone inflammation was significant and his gait and posture had changed to compensate his abnormal use of the knee to cause the muscular discomfort. On an unknown date, the swelling went down significantly since the patient started the steroids. The patient was also taking turmeric root, icing the knee, and wearing a compression stocking to help facilitate his knee returning to normal. The patient found lots of information online about that type of reaction occurring in patients who had multiple injections, specifically patients who had more than 5 injections in the past. On an unknown date in 2016, eight weeks after his last injection of synvisc one, the patient had only improved about 40% (therapeutic response decreased). The patient still had lingering pain, immobility and a feeling of fullness in his knee. It was reported that his doctor did not know what to do and just kept telling him that he would get better. The patient was angry because his doctor "sold" him the injection that was poisoning his body. It was reported that in all injections prior to 6th injection, the patient felt fine. It was reported that last synvisc one injection made the patient felt crippled and in pain all the time. It was reported that the patient felt like a little person in his knee banging with a hammer. Corrective treatment: methylprednisolone for occasional numbness of the upper back and trunk muscles, generalized muscle pain; oral steroids, turmeric root, icing, wearing compression stocking for inflammation and unable to bend knee/could not bend it past 20 degrees; not reported for leg cramps, nausea; unknown for immobility/makes him feel crippled and leg was swollen it was the size of his upper thigh. Outcome: recovering for inflammation; not recovered for immobility/makes him feel crippled; unknown for occasional numbness of the upper back and trunk muscles, generalized muscle pain, leg was swollen it was the size of his upper thigh, unable to bend knee/could not bend it past 20 degrees, leg cramps, nausea. (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr process. Sanofi genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. Sanofi genzyme biosurgery would continue to monitor adverse events to determine if a capa was required. Seriousness criterion: required intervention for occasional numbness of the upper back and trunk muscles, generalized muscle pain, inflammation and unable to bend knee/could not bend it past 20 degrees additional information was received on 17-may-2016. Global ptc number and ptc results were added. Text was amended accordingly. Additional information was received on 10-jun-2016. The events of immobility and eight weeks after his last injection of synvisc one, he has only improved about 40%/still has lingering pain (therapeutic response decreased) were added with details. The verbatim for the symptom of stiffness was updated to stiffness/feeling of fullness in knee. Clinical course updated and text amended accordingly. Additional information was received on 13-jun-2016 from the patient. The linking term for the event of inflammation was updated from inflammation to joint inflammation. The verbatim of symptom of "severe pain" was updated to "severe pain/feels like a little person is in his knee banging with a hammer"and of the symptom of "incredeble swelling/leg was swollen it was the size of his upper thigh" was updated to "incredeble swelling". The event of "leg was swollen it was the size of his upper thigh" was added. Clinical course updated and text was amended accordingly. Additional information was received on 27-jun-2016 from the patient. A related case was added. The age and medical history of the patient were added. The events of occasional numbness of the upper back and trunk muscles and generalized muscle pain were added with details. The suspect product start date was updated. Clinical course updated and text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 27-jun-2016: this case concerns a patient who reported receiving synvisc one in right knee and experienced unable to bend knee, occasional numbness of the upper back and trunk muscles and generalized muscle pain after a few days. Based upon the positive temporal relationship and the nature of the events the causal role of product in the occurrence of the events cannot be denied. However, the lack of information regarding technique of the injection and conditions under which he received the injection is required to make complete case assessment. Also, since the patient had tolerated the synvisc one injections in the past a detailed explanation of the adverse events along with complete etiology is required for a comprehensive case assessment.
 
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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
Manufacturer Contact
kristen sharma
55 corporate drive
55c-235a
bridgewater, NJ 08807
9089812784
MDR Report Key5652694
MDR Text Key45206799
Report Number2246315-2016-00073
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/13/2016 Patient Sequence Number: 1
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