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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 12/01/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on 29-dec-2017 from a patient. This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later after 1 month there was presence of the gram positive bacterium streptococcus viridans/bacterial infection streptococcus viridans, could not walk/ dragging foot and blister on right foot. The patient had medical history of placement (and later removal) of pins and screws into left hip due to fracture as a result of falling. The patient did not have concomitant treatment with immunosuppressants. The patient did not have allergy to avian proteins, feathers, or egg products. The patient was well nourished with good hygiene. The patient had past treatment with 2 synvisc one injections (for bone-onbone osteoarthritis without any side effects; in fact, she thought that they were "wonderful" in how they helped with her affected right knee; had immediate relief). Patient had emphysema, bronchitis, gerd (gastroesophageal reflux disease) and seizures. Patient had dust allergy-sneezing and shortness of breath. Concomitant medications include phenobarbital for seizures, dexlansoprazole (dexilant) for gerd and tiotropium bromide (spiriva) for bronchitis. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency: unknown) for osteoarthritis. Cold stuff was sprayed on right knee before injection. It was reported that the orthopedist instructed her not to go to the gym as she went home and placed ice on the affected knee elevating it as instructed. The same day, the patient experienced a debilitating adverse reaction due to an infection. On the same day, within four hours her right knee had "swelled to the size of a basketball feeling hot" and she experienced related pain "immediately" due to the swelling (that was a "12" on a scale of 1 to 10) so she could not walk for three more days. It was reported that the patient experienced a fever on 101 by that saturday due to the chills that she experienced "all day". The patient self-treated with paracetamol (tylenol). The patient was initially evaluated by an er physician who diagnosed her with a knee infection injecting into her right buttocks area an unknown antibiotic as treatment and prescribing hydromorphone hydrochloride (dilaudid) for the related pain. By the next tuesday in (b)(6) 2017, the patient she saw her attending orthopedist and since she was "a little better but she still could not walk" (latency: 1 month). On an unknown date in (b)(6) 2017, the patient developed a blister on her right foot because she was dragging it. The patient had an elevator to get around along with the help of others. It was reported that the orthopedist gave her two options - she could suffer through the pain and swelling or he could aspirate the right knee to remove the associated fluid. Reportedly, since the patient used to be a chemist and pharmaceutical sales representative, she decided to have an aspirate taken to have the fluid cultured to confirm that the knee was not infected as the orthopedist did not think it was infected so he stopped her use of levofloxacin which she had taken (as prescribed by the er physician) for three days. On (b)(6) 2017, one week later, the culture indicated the presence of a gram positive bacterium/ bacterial infection streptococcus viridans. Patient had swelling, extreme pain and fever. Specifically, culture report noted "wbcs observed no organisms via gram stain, but the body fluid culture indicated the presence of the gram positive bacterium streptococcus viridans from broth only. It was reported that no further culture needed. No growth on original isolated culture media was there. The patient noted that she was told that this bacterium was often found in the mouth. So the attending orthopedist prescribed a new antibiotic cefalexin monohydrate (keflex) which she took for 5 days. It was reported that another culture aspirate was obtained because the knee was still swollen and painful. Reportedly, the culture indicated "no bacterial infection. On (b)(6) 2017, the patient saw the attending orthopedist who wanted to inject her with another synvisc-one injection because of the aspirations having been performed removing intra-articular fluid along with the injected synvisc-one product but her insurance would probably not cover it and due to this the patient requested replacement of 1 synvisc one injection in light of her recent ae-ptc experience having received the affected recall lot number. The patient requested compensation for her ae-ptc experience in terms of how it affected her life before her next scheduled appointment with the orthopedist on (b)(6) 2018. On (b)(6) 2017 the patient still experienced some pain especially walking down the stairs. Corrective treatment: levofloxacin, cefalexin monohydrate (keflex) for presence of the gram positive bacterium streptococcus viridans/bacterial infection streptococcus viridans; not reported for rest of the events outcome: unknown for blister on right foot; not recovered for rest events a global pharmaceutical technical complaint was initiated and ptc results were pending for the same. Seriousness criteria: important medical event for presence of the gram positive bacterium streptococcus viridans/bacterial infection streptococcus viridans additional information was received on 22-jan-2018 from patient. Verbatim was updated for the event of presence of the gram positive bacterium streptococcus viridans to presence of the gram positive bacterium streptococcus viridans/bacterial infection streptococcus viridans. Medical history and concomitant medications added. Clinical course updated. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment follow up dated 22-jan-2018: follow up information did not change the previous case assessment. This case concerns a female patient who received synvisc one injection and there was presence of the gram positive bacterium streptococcus viridans in the aspirated fluid. Based upon the available information, the causal role of the product cannot be denied with the occurrence of events. Further information regarding patient's current clinical presentation, technique of injection, medical history, concomitant medications and other risk factors would help in the complete medical assessment of the case.
 
Event Description
This unsolicited case from united states was received on 29-dec-2017 from a patient. This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later after 1 month there was presence of the gram positive bacterium streptococcus viridans/bacterial infection streptococcus viridans, could not walk/ dragging foot/ not able to walk and blister on right foot. The patient had medical history of placement (and later removal) of pins and screws into left hip due to fracture as a result of falling. The patient did not have concomitant treatment with immunosuppressants. The patient did not have allergy to avian proteins, feathers, or egg products. The patient was well nourished with good hygiene. The patient had past treatment with 2 synvisc one injections (for bone-onbone osteoarthritis without any side effects; in fact, she thought that they were "wonderful" in how they helped with her affected right knee; had immediate relief). Patient had emphysema, bronchitis, gerd (gastroesophageal reflux disease) and seizures. Patient had dust allergy-sneezing and shortness of breath. Concomitant medications include phenobarbital for seizures, dexlansoprazole (dexilant) for gerd and tiotropium bromide (spiriva) for bronchitis. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency: unknown) for osteoarthritis. Cold stuff was sprayed on right knee before injection. It was reported that the orthopedist instructed her not to go to the gym as she went home and placed ice on the affected knee elevating it as instructed. The same day, the patient experienced a debilitating adverse reaction due to an infection. On the same day, within four hours her right knee had "swelled to the size of a basketball feeling hot" and she experienced related pain "immediately" due to the swelling (that was a "12" on a scale of 1 to 10) so she could not walk for three more days. It was reported that the patient experienced a fever on 101 by that saturday due to the chills that she experienced "all day". The patient self-treated with paracetamol (tylenol). The patient was initially evaluated by an er physician who diagnosed her with a knee infection injecting into her right buttocks area an unknown antibiotic as treatment and prescribing hydromorphone hydrochloride (dilaudid) for the related pain. By the next tuesday in (b)(6) 2017, the patient she saw her attending orthopedist and since she was "a little better but she still could not walk" (latency: 1 month). On an unknown date in (b)(6) 2017, the patient developed a blister on her right foot because she was dragging it. The patient had an elevator to get around along with the help of others. It was reported that the orthopedist gave her two options - she could suffer through the pain and swelling or he could aspirate the right knee to remove the associated fluid. Reportedly, since the patient used to be a chemist and pharmaceutical sales representative, she decided to have an aspirate taken to have the fluid cultured to confirm that the knee was not infected as the orthopedist did not think it was infected so he stopped her use of levofloxacin which she had taken (as prescribed by the er physician) for three days. On (b)(6) 2017, one week later, the culture indicated the presence of a gram positive bacterium/ bacterial infection streptococcus viridans. Patient had swelling, extreme pain and fever. Specifically, culture report noted "wbcs observed no organisms via gram stain, but the body fluid culture indicated the presence of the gram positive bacterium streptococcus viridans from broth only. It was reported that no further culture needed. No growth on original isolated culture media was there. The patient noted that she was told that this bacterium was often found in the mouth. So the attending orthopedist prescribed a new antibiotic cefalexin monohydrate (keflex) which she took for 5 days. It was reported that another culture aspirate was obtained because the knee was still swollen and painful. Reportedly, the culture indicated "no bacterial infection. On (b)(6) 2017, the patient saw the attending orthopedist who wanted to inject her with another synvisc-one injection because of the aspirations having been performed removing intra-articular fluid along with the injected synvisc-one product but her insurance would probably not cover it and due to this the patient requested replacement of 1 synvisc one injection in light of her recent ae-ptc experience having received the affected recall lot number. The patient requested compensation for her ae-ptc experience in terms of how it affected her life before her next scheduled appointment with the orthopedist on (b)(6) 2018. On (b)(6) 2017 the patient still experienced some pain especially walking down the stairs. It was reported that the patient had a lot of pain and was not able to walk. The patient had been to the er and to her orthopedic doctor six times. The patient needed another shot and her doctor recommended her to ask for a free replacement shot. Corrective treatment: levofloxacin, cefalexin monohydrate (keflex) for presence of the gram positive bacterium streptococcus viridans/bacterial infection streptococcus viridans; not reported for rest of the events outcome: unknown for blister on right foot; not recovered for rest events 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 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 would continue to monitor adverse events to determine if a capa was required. Seriousness criteria: important medical event for presence of the gram positive bacterium streptococcus viridans/bacterial infection streptococcus viridans additional information was received on 22-jan-2018 from patient. Verbatim was updated for the event of presence of the gram positive bacterium streptococcus viridans to presence of the gram positive bacterium streptococcus viridans/bacterial infection streptococcus viridans. Medical history and concomitant medications added. Clinical course updated. Text was amended accordingly. Follow up was received on 30-jan-2018. The verbatim for the event of could not walk/ dragging foot was updated to could not walk/ dragging foot/ not able to walk and that of the symptom of pain/extreme pain was updated to pain/extreme pain/ lot of pain. Additional information was received on 30-jan-2018. Global ptc number and ptc results were added. Clinical course updated. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow-up dated 30-jan-2018: the new follow-up information received does not change the previous case assessment. This case concerns a female patient who received synvisc one injection and there was presence of the gram positive bacterium streptococcus viridans in the aspirated fluid. Based upon the available information, the causal role of the product cannot be denied with the occurrence of events; however, information regarding patient's current clinical presentation, technique of injection, medical history, concomitant medications and other risk factors would help in the complete medical assessment of the case.
 
Event Description
This unsolicited case from united states was received on 29-dec-2017 from a patient. This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency there was presence of the gram positive bacterium streptococcus viridans, could not walk/ dragging foot and blister on right foot. No concomitant medication or concurrent condition was provided. The patient had medical history of placement (and later removal) of pins and screws into left hip due to fracture as a result of falling. The patient did not have concomitant treatment with immunosuppressants. The patient did not have allergy to avian proteins, feathers, or egg products. The patient was well nourished with good hygiene. The patient had past treatment with 2 synvisc one injections (for bone-onbone osteoarthritis without any side effects; in fact, she thought that they were "wonderful" in how they helped with her affected right knee; had immediate relief). On an unknown date in (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency: unknown) for osteoarthritis. Cold stuff was sprayed on right knee before injection. It was reported that the orthopedist instructed her not to go to the gym as she went home and placed ice on the affected knee elevating it as instructed. The same day, the patient experienced a debilitating adverse reaction due to an infection. On the same day, within four hours her right knee had "swelled to the size of a basketball feeling hot" and she experienced related pain "immediately" due to the swelling (that was a "12" on a scale of 1 to 10) so she could not walk for three more days. It was reported that the patient experienced a fever on 101 by that saturday due to the chills that she experienced "all day". The patient self-treated with paracetamol (tylenol). The patient was initially evaluated by an er physician who diagnosed her with a knee infection injecting into her right buttocks area an unknown antibiotic as treatment and prescribing hydromorphone hydrochloride (dilaudid) for the related pain. By the next tuesday in (b)(6) 2017, the patient saw her attending orthopedist and since she was "a little better but she still could not walk" (latency: unknown). On an unknown date in (b)(6) 2017, the patient developed a blister on her right foot because she was dragging it. The patient had an elevator to get around along with the help of others. It was reported that the orthopedist gave her two options - she could suffer through the pain and swelling or he could aspirate the right knee to remove the associated fluid. Reportedly, since the patient used to be a chemist and pharmaceutical sales representative, she decided to have an aspirate taken to have the fluid cultured to confirm that the knee was not infected as the orthopedist did not think it was infected so he stopped her use of levofloxacin which she had taken (as prescribed by the er physician) for three days. On an unknown date in (b)(6) 2017, one week later, the culture indicated the presence of a gram positive bacterium. Specifically, culture report noted "wbcs observed no organisms via gram stain, but the body fluid culture indicated the presence of the gram positive bacterium streptococcus viridans from broth only. It was reported that no further culture needed. No growth on original isolated culture media was there. The patient noted that she was told that this bacterium was often found in the mouth. So the attending orthopedist prescribed a new antibiotic cefalexin monohydrate (keflex) which she took for 5 days. It was reported that another culture aspirate was obtained because the knee was still swollen and painful. Reportedly, the culture indicated "no bacterial infection. On (b)(6) 2017, the patient saw the attending orthopedist who wanted to inject her with another synvisc-one injection because of the aspirations having been performed removing intra-articular fluid along with the injected synvisc-one product but her insurance would probably not cover it and due to this the patient requested replacement of 1 synvisc one injection in light of her recent ae-ptc experience having received the affected recall lot number. The patient requested compensation for her ae-ptc experience in terms of how it affected her life before her next scheduled appointment with the orthopedist on (b)(6) 2018. On (b)(6) 2017 the patient still experienced some pain especially walking down the stairs. Corrective treatment: levofloxacin, cefalexin monohydrate (keflex) for presence of the gram positive bacterium streptococcus viridans; not reported for rest of the events outcome: recovered for presence of the gram positive bacterium streptococcus viridans; not recovered for could not walk/ dragging foot; unknown for blister on right foot a global pharmaceutical technical complaint was initiated and ptc results were pending for the same. Seriousness criteria: important medical event for presence of the gram positive bacterium streptococcus viridans pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a female patient who received synvisc one injection and there was presence of the gram positive bacterium streptococcus viridans in the aspirated fluid. Based upon the available information, the causal role of the product cannot be denied with the occurrence of events. Further information regarding patient's current clinical presentation, technique of injection, medical history, concomitant medications and other risk factors would help in the complete medical assessment of the case.
 
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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 Key7174990
MDR Text Key284354842
Report Number2246315-2018-00076
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
Report Date 12/29/2017
1 Device was Involved in the Event
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? No
Device Operator Other
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
Treatment
DEXILANT(CON.) - START; DEXILANT(CON.) - START; DEXILANT(CON.) - STOP UNKNOWN; DEXILANT(CON.) - STOP UNKNOWN; PHENOBARBITAL(CON.); PHENOBARBITAL(CON.); SPIRIVA(CON.); SPIRIVA(CON.); SYNVISC ONE (PREV.); SYNVISC ONE(PREV.); SYNVISC ONE(PREV.); SYNVISC ONE (PREV.)
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