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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 Arthritis (1723); Bacterial Infection (1735); Inflammation (1932); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)
Event Date 12/04/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 14-dec-2017 from other health care professional and patient this case concerns (b)(6) year old female patients who received treatment with synvisc one injection and ibuprofen (motrin) after an unknown latency had limping, can't lift the leg up to put shoes on, gi (stomach) problems and inflammation. Also, device malfunction was identified for the reported lot number. No relevant medical history were reported. It was stated that patient had received a synvisc-one injection in the same knee on (b)(6)-2017 and stated she had good results and had no discomfort. Patient did not have an allergy history to avian proteins, feathers, or egg products. Patient had allergy to dairy gluten- gas. On (b)(6)-2017, at 11 am, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once (expiration date: 31-mar-2020 and lot number: 7rsl021) for arthritis in left knee. On the same day, several hours later "around 5 pm" patient reported "a lot of pain, swelling/ swollen, stiffness in the right knee. Real stiff. " patient was up all night with pain and discomfort in knee. Patient appointment was at 10:30 or 11:00 am. Everything was fine. Then about 5:00 pm, my knee started getting stiff. It kept getting stiffer. Patient was up all night and was in pain all night. The swelling was huge. Now, patient was still have pain and swelling and was limping. Patient called doctor at 5:30. The pain was lessened. But, patient cannot lift the leg up to put shoes on (onset date: (b)(6)-2017; latency: unknown). Patient was going to the doctor tomorrow. Patient was icing it last night. It was still painful. Patient took ibuprofen the night of the injection ((b)(6)-2017) and the next day and then stopped taking it (form, route, frequency and indication: not reported). Nurse stated, that the patient walked out of the office after the injection, had not done any jogging activities after the injection. Patient was able to bear weight before and after injection, up until 5:00 pm and did not require a cane or walker. Patient was holding onto the railing for support on the stairs. Patient pain was a 0 before the injection and it was a 10 that evening. Patient has a high pain tolerance and rarely take pain medications. Patient did not have a fever and they did not do blood work. When patient went back to the office, they took fluid out of the knee and the culture came back negative (onset date: (b)(6)-2017; latency: unknown). For treatment, they drained it. They want me to go in tomorrow and give me a patch for the inflammation. It was still swollen, but not as bad. Patient was treating the injected knee with ice, " ibuprofen," no antibiotics were given, and hcp (health care professional) decided against using medrol dose pack after receiving 2nd letter mentioning "gram negative. " it was stated, that on (b)(6)-2017, the patient came into hcp's office limping (onset date: (b)(6)-2017; latency unknown). Patient did not mention level of pain according to pain scale, and denied fever. It was stated that no blood work was done, did knee aspiration, a culture & sensitivity, crystals, and cell count was done, and hcp has the results of cultures. It was reported that the patient has stopped taking "motrin" due to having gi (stomach) problems (onset date: (b)(6)- 2017; latency unknown), was elevating the aspirated knee, and continued to report pain and inflammation as of tuesday. It was stated, that the patient would be re-assessed tomorrow for a possible second aspiration of the injected knee. It was reported that the patient has not been hospitalized, has not recovered from this event, has no prosthetic devices, has no known allergies, has no known overall health issues, was well nourished, and has good hygiene. It was stated that the sterile technique was used, the package was opened after questioning the patient, when patient was ready for the injection, anesthetics were injected at the time of the synvisc-one injection, and the synvisc-one injection was stored at "room temperature. " patient do not have any prosthetic device e. G. Prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator and do not had previous/concomitant treatment with immunosuppressants. Patient was in really good health for my age. The doctor did use lidocaine. Patient cannot remember if he injected it or sprayed it on. Patient only concern was that she love the shot and do want to get another one if can. It was reported that doctor might drain knee again. Action taken: unknown for ibuprofen corrective treatment: not reported for device malfunction; ice, elevation, ibuprofen for rest events outcome: not recovered for all events a pharmaceutical technical complaint (ptc) was initiated 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 was under investigation. Once this investigation was completed, corrective and preventive actions would be implemented. Seriousness criterion: important medical event for device malfunction follow up information was received on 04-jan-2018. Global ptc number was added. Text was amended accordingly additional information was received on 15-jan-2018. Discomfort in knee was added as symptom of inflammation; events of a lot of pain/was up all night with pain/was in pain all night/painful, swelling/swelling was huge/swollen, stiffness in left knee/my knee started getting stiff/ kept getting stiffer/knee got real stiff and knee aspiration/drained/might drain my knee again/all fluid removed from knee were updated from diagnosis to symptom of inflammation. Clinical course updated. Text was amended accordingly pharmacovigilance comment: sanofi company comment dated 22-dec-2017: this case concerns a patient who experienced limping, lower extremity dysfunction, left knee swelling, left knee pain, joint stiffness, effusion (l) knee and joint inflammation after receiving synvisc one injection from the recalled lot. Although exact event onset date have not been provided for all the events, temporal relationship can still be established between the event and the suspect product based on the available information. Additionally, as the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relation of the events to the product cannot be excluded.
 
Event Description
This unsolicited case from united states was received on 14-dec-2017 from other health care professional and patient this case concerns (b)(6) year old female patients who received treatment with synvisc one injection and ibuprofen (b)(6) after few hours had a lot of pain/ was up all night with pain/was in pain all night/ painful, swelling/swelling was huge/swollen, stiffness in left knee/my knee started getting stiff/ kept getting stiffer and inflammation; after unknown latency, patient had limping, can't lift the leg up to put shoes on, had gi (stomach) problems, knee aspiration/drained/might drain my knee again. Also, device malfunction was identified for the reported lot number. No relevant medical history were reported. It was stated that patient had received a synvisc-one injection in the same knee on (b)(6) 2017 and stated she had good results and had no discomfort. Patient did not have an allergy history to avian proteins, feathers, or egg products. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once (expiration date: 31-mar-2020 and lot number: 7rsl021) for arthritis in left knee. On the same day, several hours later "around 5 pm" patient reported "a lot of pain, swelling, stiffness in the right knee. " patient was up all night with pain. Patient appointment was at 10:30 or 11:00 am. Everything was fine. Then about 5:00 pm, my knee started getting stiff. It kept getting stiffer. Patient was up all night and was in pain all night. The swelling was huge. Now, patient was still have pain and swelling and was limping. The pain was lessened. But, patient cannot lift the leg up to put shoes on (onset date: (b)(6) 2017; latency: unknown). Patient was going to the doctor tomorrow. Patient was icing it last night. It was still painful. Patient took ibuprofen the night of the injection (b)(6) 2017) and the next day and then stopped taking it (form, route, frequency and indication: not reported). Nurse stated, that the patient walked out of the office after the injection, had not done any jogging activities after the injection. Patient was able to bear weight before and after injection, up until 5:00 pm and did not require a cane or walker. Patient was holding onto the railing for support on the stairs. Patient pain was a 0 before the injection and it was a 10 that evening. Patient has a high pain tolerance and rarely take pain medications. Patient did not have a fever and they did not do blood work. When patient went back to the office, they took fluid out of the knee and the culture came back negative (onset date: (b)(6) 2017; latency: unknown). For treatment, they drained it. They want me to go in tomorrow and give me a patch for the inflammation. It was still swollen, but not as bad. Patient was treating the injected knee with ice, " ibuprofen," no antibiotics were given, and hcp (health care professional) decided against using medrol dose pack after receiving 2nd letter mentioning "gram negative. " it was stated, that on (b)(6) 2017, the patient came into hcp's office limping (onset date:(b)(6) 2017; latency unknown). Patient did not mention level of pain according to pain scale, and denied fever. It was stated that no blood work was done, did knee aspiration, a culture & sensitivity, crystals, and cell count was done, and hcp has the results of cultures. It was reported that the patient has stopped taking "motrin" due to having gi (stomach) problems (onset date: (b)(6) 2017; latency unknown), was elevating the aspirated knee, and continued to report pain and inflammation as of tuesday. It was stated, that the patient would be re-assessed tomorrow for a possible second aspiration of the injected knee. It was reported that the patient has not been hospitalized, has not recovered from this event, has no prosthetic devices, has no known allergies, has no known overall health issues, was well nourished, and has good hygiene. It was stated that the sterile technique was used, the package was opened after questioning the patient, when patient was ready for the injection, anesthetics were injected at the time of the synvisc-one injection, and the synvisc-one injection was stored at "room temperature. " patient do not have any prosthetic device e. G. Prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator and do not had previous/concomitant treatment with immunosuppressants. Patient was in really good health for my age. The doctor did use lidocaine. Patient cannot remember if he injected it or sprayed it on. Patient only concern was that she love the shot and do want to get another one if can. It was reported that doctor might drain knee again. Action taken: unknown for ibuprofen. Corrective treatment: not reported for device malfunction; ice, elevation, ibuprofen for rest events. Outcome: recovering for a lot of pain/was up all night with pain/was in pain all night/painful; not recovered for rest 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 was completed, corrective and preventive actions would be implemented. Seriousness criterion: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 22-dec-2017: this case concerns a patient who experienced limping, lower extremity dysfunction, left knee swelling, left knee pain, joint stiffness, effusion (l) knee and joint inflammation after receiving synvisc one injection from the recalled lot. Although exact event onset date have not been provided for all the events, temporal relationship can still be established between the event and the suspect product based on the available information. Additionally, as the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relation 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 Key7174435
MDR Text Key283397455
Report Number2246315-2017-00501
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
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
Report Date 12/14/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/09/2018
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 Received03/06/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
Treatment
LIDOCAINE(CON.)
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