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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 Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Reaction (2414); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
Based on additional information received on 14-feb- 2017, this case initially considered as non-serious was upgraded to serious (serious event of pseudoseptic reaction was added). This unsolicited device case from united states was received on 10-mar-2016 from a physician. This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency patient had pseudoseptic reaction and was unable to bear weight on left leg without support. The patient had received synvisc one injection without any issues. Medical history included osteoarthritis in left and right knees, claustrophobia, elevated cholesterol and type ii diabetes. Concomitant medications included ezetimibe/simvastatin (vytorin) and metformin hydrochloride (metformin). Patient denied any changes to her tobacco, alcohol use and recreational drug use. Patient reported reduction of caffeinated beverages since previous orthopedic problem (unspecified). Surgery history included unspecified surgeries and hospitalizations. On (b)(6) 2015, the right knee x-ray showed degenerative arthritis right knee and left knee x-ray showed progressive arthritis left knee joint. Patient had no known allergies. Patient was retired person. On (b)(6) 2015, the patient was evaluated for left and right knee. The patient had intermittent aching and throbbing pain. It was reported that symptoms worsen as the day progressed. There was no evidence of infection. Patient was suggested ice packs, meloxicam (mobic) twice a day and tramadol hydrochloride (tramadol) tables at the dose of 50 mg for some of the discomfort. Patient took meloxicam which slightly helped. Left and right knee examination showed mild medial joint line tenderness, lateral joint line tenderness, patello-femoral tenderness and patello-femoral crepitus in both the knees and range of motion: extension 5 and flexion 100 for left knee and 0 and 100 for right knee respectively. The same day, the patient received treatment with intra-articular synvisc one injection, 6cc once (dose, indication, batch/lot number and expiration date: not provided) in the bilateral knees under aseptic technique. On (b)(6) 2015, the patient experienced swelling, moderate pain and heat in the injected knee following the injection. Patient was suggested that the symptoms would clear on 24- 48 hours following the injection. On (b)(6) 2016, the patient reported that left knee was more painful. Patient visited the physician due to increased pain and swelling in the left knee. Patient complained of persistent severe pain and swelling. Patient was unable to bear weight on the left leg without support. Reportedly, the patient was ambulating with one crutch. Patient was also taking meloxicam/ tramadol hydrochloride as needed for pain. In regards to the right knee, the symptoms had greatly improved. She does not express any complaints or concerns at this time. Left knee examination showed moderate effusion (on inspection), moderate medial joint line tenderness, mild lateral joint line tenderness, mild patellofemoral tenderness and mild patellofemoral crepitus (on palpitation) and range of motion: extension as 10 and flexion as 80 with pain. Right knee examination showed mild patellofemoral crepitus, mild patello-femoral apprehension and range of motion: extension as 0 and flexion as 120. Patient likely had inflammatory reaction to synvisc-one injection. Fluid was aspirated from the left knee which was negative for infection. Fluid aspirate showed white blood cells (wbc) as 72962, gram stain: moderate wbc with no organisms and crystals, negative cultures, lyme pcr was negative. Patient was instructed to return in one week for follow-up as needed. As of (b)(6) 2016, the patient reported that her left knee was more symptomatic and continued to complain of severe persistent pain at this time. Patient also complained of swelling in her left knee. X-ray of left knee showed varus alignment, severe medial did, moderate patellofemoral did, marginal osteophytes. Corticosteroid injection performed in left knee under sterile conditions. Patient declined repeat aspiration. Patient was recommended over the counter (otc) medications and/or anti-inflammatory medications and/or pain medications, ice modality, avoidance of exacerbating activities and watchful observation. Patient was instructed to return in two weeks for follow-up as needed. On (b)(6) 2016, the patient continued to have persistent pain and swelling in both knees. Patient experienced difficulty with walking and standing and currently ambulates with crutches. Patient took no medication for symptom relief. Patient had taken norco which caused side effects so she stopped. Otc medications were not helpful. Left knee examination showed mild to moderate effusion (on inspection), moderate medial joint line tenderness, mild lateral joint line tenderness, mild patellofemoral tenderness and mild patellofemoral crepitus (on palpitation) and range of motion: extension as 10 and flexion as 95 with pain. Right knee examination showed mild effusion, mild medial joint line tenderness, mild lateral joint line tenderness, mild patellofemoral crepitus, mild patello-femoral apprehension and range of motion: extension as 0 and flexion as 100. As of (b)(6) -2016, the patient reported that his symptoms had remained about the same. Patient continues with mild to moderate knee pain which worsens with running or prolonged standing. On (b)(6) 2016, the patient would be administered a synvisc-one injection into bilateral knee corrective treatment: steroid (unspecified), anti-inflammatory medication, meloxicam and tramadol hydrochloride for pseudoseptic reactions; crutch for unable to bear weight on left leg without support a pharmaceutical technical complaint was initiated with (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. 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. Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required. Outcome: not recovered for both the events seriousness criterion: required intervention for pseudoseptic reaction additional information was received on 22-mar-2016. Global ptc number with results was added and the text was amended accordingly. Additional information was received on 14-feb-2017 from the physician. Age of the patient was added. Therapy start date was added. Events of had pain, swelling and heat in the injected knee were updated to associated symptoms of pseudo-septic reaction. Additional events of pseudo-septic reaction and unable to bear weight on left leg without support were added along with details. Laboratory data was added. Clinical course was amended accordingly. Test was amended accordingly.
 
Event Description
Based on additional information received on 14-feb- 2017, this case initially considered as non-serious was upgraded to serious (serious event of pseudoseptic reaction was added). This unsolicited device case from united states was received on 10-mar-2016 from a physician. This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency patient had pseudoseptic reaction and was unable to bear weight on left leg without support. The patient had received synvisc one injection without any issues. Medical history included osteoarthritis in left and right knees, claustrophobia, elevated cholesterol and type ii diabetes. Concomitant medications included ezetimibe/simvastatin (vytorin) and metformin hydrochloride (metformin). Patient denied any changes to her tobacco, alcohol use and recreational drug use. Patient reported reduction of caffeinated beverages since previous orthopedic problem (unspecified). Surgery history included unspecified surgeries and hospitalizations. On (b)(6) 2015, the right knee x-ray showed degenerative arthritis right knee and left knee x-ray showed progressive arthritis left knee joint. Patient had no known allergies. Patient was retired person. On (b)(6) 2015, the patient was evaluated for left and right knee. The patient had intermittent aching and throbbing pain. It was reported that symptoms worsen as the day progressed. There was no evidence of infection. Patient was suggested ice packs, meloxicam (mobic) twice a day and tramadol hydrochloride (tramadol) tables at the dose of 50 mg for some of the discomfort. Patient took meloxicam which slightly helped. Left and right knee examination showed mild medial joint line tenderness, lateral joint line tenderness, patello-femoral tenderness and patello-femoral crepitus in both the knees and range of motion: extension 5 and flexion 100 for left knee and 0 and 100 for right knee respectively. The same day, the patient received treatment with intra-articular synvisc one injection, 6cc once (dose, indication, batch/lot number and expiration date: not provided) in the bilateral knees under aseptic technique. On (b)(6) 2015, the patient experienced swelling, moderate pain and heat in the injected knee following the injection. Patient was suggested that the symptoms would clear on 24- 48 hours following the injection. On (b)(6) 2016, the patient reported that left knee was more painful. Patient visited the physician due to increased pain and swelling in the left knee. Patient complained of persistent severe pain and swelling. Patient was unable to bear weight on the left leg without support. Reportedly, the patient was ambulating with one crutch. Patient was also taking meloxicam/ tramadol hydrochloride as needed for pain. In regards to the right knee, the symptoms had greatly improved. She does not express any complaints or concerns at this time. Left knee examination showed moderate effusion (on inspection), moderate medial joint line tenderness, mild lateral joint line tenderness, mild patellofemoral tenderness and mild patellofemoral crepitus (on palpitation) and range of motion: extension as 10 and flexion as 80 with pain. Right knee examination showed mild patellofemoral crepitus, mild patello-femoral apprehension and range of motion: extension as 0 and flexion as 120. Patient likely had inflammatory reaction to synvisc-one injection. Fluid was aspirated from the left knee which was negative for infection. Fluid aspirate showed white blood cells (wbc) as 72962, gram stain: moderate wbc with no organisms and crystals, negative cultures, lyme pcr was negative. Patient was instructed to return in one week for follow-up as needed. As of (b)(6) 2016, the patient reported that her left knee was more symptomatic and continued to complain of severe persistent pain at this time. Patient also complained of swelling in her left knee. X-ray of left knee showed varus alignment, severe medial did, moderate patellofemoral did, marginal osteophytes. Corticosteroid injection performed in left knee under sterile conditions. Patient declined repeat aspiration. Patient was recommended over the counter (otc) medications and/or anti-inflammatory medications and/or pain medications, ice modality, avoidance of exacerbating activities and watchful observation. Patient was instructed to return in two weeks for follow-up as needed. On (b)(6) 2016, the patient continued to have persistent pain and swelling in both knees. Patient experienced difficulty with walking and standing and currently ambulates with crutches. Patient took no medication for symptom relief. Patient had taken norco which caused side effects so she stopped. Otc medications were not helpful. Left knee examination showed mild to moderate effusion (on inspection), moderate medial joint line tenderness, mild lateral joint line tenderness, mild patellofemoral tenderness and mild patellofemoral crepitus (on palpitation) and range of motion: extension as 10 and flexion as 95 with pain. Right knee examination showed mild effusion, mild medial joint line tenderness, mild lateral joint line tenderness, mild patellofemoral crepitus, mild patello-femoral apprehension and range of motion: extension as 0 and flexion as 100. As of (b)(6) 2016, the patient reported that his symptoms had remained about the same. Patient continues with mild to moderate knee pain which worsens with running or prolonged standing. On (b)(6) 2016, the patient would be administered a synvisc-one injection into bilateral knee. Corrective treatment: steroid (unspecified), anti-inflammatory medication, meloxicam and tramadol hydrochloride for pseudoseptic reactions; crutch for unable to bear weight on left leg without support. A pharmaceutical technical complaint 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. 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. Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required. Outcome: not recovered for both the events. Seriousness criterion: required intervention for pseudoseptic reaction. Additional information was received on 22-mar-2016. Global ptc number with results was added and the text was amended accordingly. Additional information was received on 14-feb-2017 from the physician. Age of the patient was added. Therapy start date was added. Events of had pain, swelling and heat in the injected knee were updated to associated symptoms of pseudo-septic reaction. Additional events of pseudo-septic reaction and unable to bear weight on left leg without support were added along with details. Laboratory data was added. Clinical course was amended accordingly. Test was amended accordingly. Additional information was received on 28-feb-2017. The global ptc number with ptc results were added. Text was amended accordingly.
 
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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
heather schiappacasse
55 corporate drive
55b-220a
bridgewater, NJ 08807
9089817289
MDR Report Key6360065
MDR Text Key68360852
Report Number2246315-2017-00026
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
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: 02/27/2017 Patient Sequence Number: 1
Treatment
METFORMIN (CON.); SYNVISC ONE (PREV.); VYTORIN (CON.)
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