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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 Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on (b)(6) 2018 from the patient. This case concerns a (b)(6) male patient who received treatment with synvisc one injection and on the same day experienced pain/ pain in knee cap/ very painful, swelling/ knee was swollen to twice, fluid removed, inability to bear weight/ unable to bear weight and could not walk. Also, device malfunction was identified for the reported lot number. Patient's medical history was significant for his knee was sore and he had a pain level of 6 out of 10. No past medications and concomitant medications were reported. It was reported that the patient had no prostheses, no allergies at all. The patient did not have diabetes, any other chronic disease and no history of immune suppressant therapy other than cortisone injections in his knee. On unknown date in first week of (b)(6) 2017, (friday 1 pm), the patient received treatment with intra articular synvisc one injection, at a dose of 1 injection, once (lot number 7rsl021) in his left knee. On the same day, by that night, patient experienced pain, swelling and inability to bear weight on his knee, he could not walk, the knee was swollen to twice its normal size and it was very painful. It was reported that after the injection, his pain level was 10 out of 10. It stayed that way and he could not walk all weekend. It was reported that the patient was currently experiencing pain in his knee cap. Also, reported that patient was notified by his physician in a letter that he received the recalled product. On monday, patient started taking anti-inflammatory medication, the swelling decreased and he was able to limp around. On an unknown date in (b)(6) 2018, after few days of receiving synvisc one injection, patient went back to his doctor and fluid was removed to check for infection. The tests came back fine. Additionally reported that the patient could put weight on the knee and he was not having joint pain, but his knee cap was so sore that he walked with a limp after walking just a short distance. On (b)(6) 2018, patient had a shot of cortisone in the knee. Corrective treatment: anti-inflammatory medication and cortisone for the event of swelling/ knee was swollen to twice; fluid removed and cortisone for the event of pain/ pain in knee cap/ very painful and fluid removed; not reported for the rest of the events. Outcome: recovered/resolved for the event of pain/ pain in knee cap/ very painful; recovering/resolving for the event of could not walk, inability to bear weight/ unable to bear weight and swelling/ knee was swollen to twice; not recovered for the rest of the events a pharmaceutical technical complaint (ptc) was initiated and results were pending. Seriousness criteria: required intervention for device malfunction, pain/ pain in knee cap/ very painful, swelling/ knee was swollen to twice and fluid removed pharmacovigilance comment: sanofi company comment dated 05-feb-2018: this case concerns a male patient who received synvisc one injection from the recalled lot and had right knee pain, swelling, effusion and inability to bear weight and could not walk. 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 30-jan-2018 from the patient. This case concerns a (b)(6) year old male patient who received treatment with synvisc one injection and on the same day experienced pain/ pain in knee cap/ very painful, swelling/ knee was swollen to twice, inability to bear weight/ unable to bear weight and after few days had fluid removed. Also, device malfunction was identified for the reported lot number. Patient's medical history was significant for melanoma, afib, his knee was sore and he had a pain level of 6 out of 10. No past medications and concomitant medications were reported. It was reported that the patient had no prostheses, no allergies at all. Patient had problems from start, could not walk on it the whole weekend. Doctor prescribed diclofenac. Concomitant medication included atorvastatin, sotalol hydrochloride, olmesartan and levothyroxine sodium (levothyroxine). The patient did not have diabetes, any other chronic disease and no history of immune suppressant therapy other than cortisone injections in his knee. On (b)(6) 2017, (friday 1 pm), the patient received treatment with intra-articular synvisc one injection, at a dose of 1 injection, once (lot number 7rsl021) in his left knee. On the same day, by that night, patient experienced pain, swelling and inability to bear weight on his knee, the knee was swollen to twice its normal size and it was very painful. It was reported that after the injection, his pain level was 10 out of 10. It was reported that the patient was currently experiencing pain in his knee cap. Also, reported that patient was notified by his physician in a letter that he received the recalled product. On monday, patient started taking anti-inflammatory medication, the swelling decreased and he was able to limp around. On an unknown date in jan- 2018, after few days of receiving synvisc one injection, patient went back to his doctor and fluid was removed to check for infection. The tests came back fine. Additionally reported that the patient could put weight on the knee and he was not having joint pain. On (b)(6) 2018, patient had a shot of cortisone in the knee. It was reported that patient had problem walking with left knee, went to doctor. They x-rayed it, gave patient a shot of cortisone, it helped for about 02 weeks, went back. They decided to use product got prior approval, injected on (b)(6) 2018. They took fluid off the knee to check for infection. Corrective treatment: anti-inflammatory medication and cortisone for the event of swelling/ knee was swollen to twice; cortisone for the event of pain/ pain in knee cap/ very painful and fluid removed, cortisone for fluid removed; not reported for the rest of the events. Outcome: recovered/resolved for the event of pain/ pain in knee cap/ very painful; recovering/resolving for the event of could not walk, inability to bear weight/ unable to bear weight and swelling/ knee was swollen to twice; not recovered for the rest of the events seriousness criteria: required intervention for device malfunction, pain/ pain in knee cap/ very painful, swelling/ knee was swollen to twice and fluid removed 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. Additional information was received on 08-feb-2018 from a patient. Suspect regimen date was updated. Event of inability to bear weight/ unable to bear weight and could not walk was deleted. Medical history, concomitant medication and concurrent condition was added. Lab test were added. Start date for the event of device malfunction, pain/ pain in knee cap/ very painful and swelling/ knee was swollen to twice. Clinical course updated. Text amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 08 - feb - 18. The follow received does not change the previous assessment of the case. : this case concerns a male patient who received synvisc one injection from the recalled lot and had right knee pain, swelling, effusion and inability to bear weight and could not walk. 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 (b)(6) 2018 from the patient. This case concerns a 76 year old male patient who received treatment with synvisc one injection and on the same day experienced pain/ pain in knee cap/ very painful, swelling/ knee was swollen to twice, inability to bear weight/ unable to bear weight and after few days had fluid removed and after unknown latency could not walk. Also, device malfunction was identified for the reported lot number. Patient's medical history was significant for melanoma, afib, his knee was sore and he had a pain level of 6 out of 10. No past medications and concomitant medications were reported. It was reported that the patient had no prostheses, no allergies at all. Patient had problems from start, could not walk on it the whole weekend. Doctor prescribed diclofenac. Concomitant medication included atorvastatin, sotalol hydrochloride, olmesartan and levothyroxine sodium (levothyroxine). The patient did not have diabetes, any other chronic disease and no history of immune suppressant therapy other than cortisone injections in his knee. On (b)(6) 2017, (friday 1 pm), the patient received treatment with intra-articular synvisc one injection, at a dose of 1 injection, once (lot number 7rsl021) in his left knee. On the same day, by that night, patient experienced pain, swelling and inability to bear weight on his knee, the knee was swollen to twice its normal size and it was very painful. It was reported that after the injection, his pain level was 10 out of 10. It was reported that the patient was currently experiencing pain in his knee cap. Also, reported that patient was notified by his physician in a letter that he received the recalled product. On monday, patient started taking anti-inflammatory medication, the swelling decreased and he was able to limp around. On an unknown date in (b)(6) 2018, after few days of receiving synvisc one injection, patient went back to his doctor and fluid was removed to check for infection. The tests came back fine. Additionally reported that the patient could put weight on the knee and he was not having joint pain. On (b)(6) 2018, patient had a shot of cortisone in the knee. It was reported that patient had problem walking with left knee, went to doctor. They x-rayed it, gave patient a shot of cortisone, it helped for about 02 weeks, went back. They decided to use product got prior approval, injected on (b)(6) 2018. They took fluid off the knee to check for infection. After his injection, the patient experienced it helped his knee problem (unspecified) but it messed up his knee characterized by he couldn't walk (onset: unknown; latency: unknown). Treatment included the doctor wanted to inject his knee again with another synvisc but was told he had to wait 6 months for the injection helped his knee problem (unspecified) but it messed up his knee characterized by he couldn't walk. The patient reported the event he was then told that his paperwork would be transferred to "legal". He received the paperwork on (b)(6) 2018, filled it all out, stapled his surgeons letter to it and mailed it back in. Then on (b)(6) 2018 he received another set of the same identical paperwork, blank this time, and his surgeons letter was attached to it, as if it was torn off the first one he mailed in and restapled to a new set. He stated so "someone ripped the surgeon's letter off the first, stapled it to new paperwork and sent it back to me asking me to fill it out again". He thought his case was being "stalled" and someone was "playing around in there" and "if they're going to play around in there then he would just contact an attorney. As of (b)(6) 2018, the injection helped his knee problem (unspecified) but it messed up his knee characterized by he couldn't walk was ongoing. At the time of this report, it was unknown if synvisc-one was ongoing. Corrective treatment: anti-inflammatory medication and cortisone for the event of swelling/ knee was swollen to twice; cortisone for the event of pain/ pain in knee cap/ very painful and fluid removed, cortisone for fluid removed; not reported for the rest of the events. Outcome: recovered/resolved for the event of pain/ pain in knee cap/ very painful; recovering/resolving for the event of could not walk, inability to bear weight/ unable to bear weight and swelling/ knee was swollen to twice; not recovered for the rest of the events seriousness criteria: required intervention for device malfunction, pain/ pain in knee cap/ very painful, swelling/ knee was swollen to twice and fluid removed 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. Additional information was received on 08-feb-2018 from a patient. Suspect regimen date was updated. Event of inability to bear weight/ unable to bear weight and could not walk was deleted. Medical history, concomitant medication and concurrent condition was added. Lab test were added. Start date for the event of device malfunction, pain/ pain in knee cap/ very painful and swelling/ knee was swollen to twice. Clinical course updated. Text amended accordingly. Additional information was received on 28-feb-2018 from a patient. Additional event could not walk along with details was added. Clinical course was updated and text was amended accordingly. (b)(6) comment: sanofi company comment for follow up dated 28-feb-18. The follow received does not change the previous assessment of the case. : this case concerns a male patient who received synvisc one injection from the recalled lot and had right knee pain, swelling, effusion and inability to bear weight and could not walk. 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.
 
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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 Key7291497
MDR Text Key101136930
Report Number2246315-2018-00291
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 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 02/23/2018 Patient Sequence Number: 1
Treatment
ATORVASTATIN(CON.)-ONGOING; ATORVASTATIN(CON.)-ONGOING; DICLOFENAC(CON.); DICLOFENAC(CON.); LEVOTHYROXINE(CON.)-ONGOING; LEVOTHYROXINE(CON.)-ONGOING; OLMESARTAN(CON.)-ONGOING; OLMESARTAN(CON.)-ONGOING; SOTALOL HYDROCHLORIDE(CON.) ONGOING; SOTALOL HYDROCHLORIDE(CON.) ONGOING
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