| Lot Number 7RSL021 |
| Device Problem
Microbial Contamination of Device (2303)
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| Patient Problems
Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
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| Event Date 11/01/2017 |
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Event Type
Injury
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Event Description
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Not been able to do usual activities like go to church because of this pain [activities of daily living impaired], device malfunction [device malfunction], pseudosepsis [pseudosepsis] ([arthralgia aggravated], [swelling of r knee]).Case narrative: this case was linked to case (b)(4) (multiple devices, left knee).Initial information received on 28-oct-2019 from united states regarding an unsolicited valid legal serious case received from a lawyer.This case involves a (b)(6) years old female patient (162.6 cm and (b)(6) kg) who experienced pseudosepsis (latency: 2 days), not been able to do usual activities like go to church because of this pain (latency: unknown) while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was also added for the identified recalled lot.Patients medical history included hyperlipidemia, depression, migraine, left ventricular hypertrophy, irritable bowel syndrome, plantar fasciitis, achilles tendinitis, iron deficiency anemia, bells palsy, nocturnal leg cramps, panic attacks, cervical dysplasia, pregnancy with four children, mammogram on (b)(6) 2012, colonoscopy on (b)(6) 2013, excision benign skin lesion back on (b)(6) 2016, knee arthroscopy right, tonsillectomy, caregiver stress in (b)(6) 2012, bronchitis in (b)(6) 2012.Patients ongoing history included asthma since (b)(6) 2013, chronic right-sided low back pain with sciatica since (b)(6) 2013, degenerative joint disease of knee since (b)(6) 2013, allergic to almonds which resulted in swelling, allergic to remezon which resulted in anxiety, hypertension, chronic narcotic use since (b)(6) 2013, lower extremity edema since (b)(6) 2013, continuous use of opioids, bilateral knee pain since (b)(6) 2014, never smoked, allergic to advair diskus which resulted in rash on tongue, genu varum since (b)(6) 2014, benign recurrent vertigo since (b)(6) 2015, obesity morbid since (b)(6) 2015, chronic pain since (b)(6) 2016, primary osteoarthritis of left knee since (b)(6) 2016, primary osteoarthritis of right knee since (b)(6) 2016, allergic reaction to amoxicillin which resulted in rash, no alcohol use.Past vaccination history included influenza in (b)(6) 2016, (b)(6) 2013, (b)(6) 2014, (b)(6) 2015, (b)(6) 2016, (b)(6) 2017 and tdap on (b)(6) 2011.Past family history included hypertension (mother, sister and brother), coronary artery disease (mother), pancreatic cancer (father), asthma (father, sister and brother), diabetes type 2 (sister, paternal grandmother and maternal aunt), colon cancer (maternal aunt), liver cancer (maternal aunt).Concomitant medications included bupropion hydrochloride (wellbutrin); clonazepam (klonopin); diclofenac (voltaren [diclofenac]); eletriptan hydrobromide (relpax); lisinopril dihydrate (prinivil); macrogol 3350 (miralax); dexamethasone (deltasone [dexamethasone]); beclometasone dipropionate (qvar); salmeterol xinafoate (serevent); gabapentin (neurontin); hyoscyamine sulfate (anaspaz) for muscle spasms; ibuprofen (advil [ibuprofen]) for pain; loratadine (claritin [loratadine]); naloxone hydrochloride (narcan); promethazine (phenergan [promethazine]) for nausea; cyclobenzaprine hydrochloride (flexeril [cyclobenzaprine hydrochloride]) for muscle spasms; salbutamol sulfate (ventolin hfa) for wheezing; and salbutamol (proventil [salbutamol]).On (b)(6) 2017, patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at dosage 6ml, frequency once in right knee (batch: 7rsl021) for primary osteoarthritis of right knee.After the risks and benefits of the procedure were explained, consent was given, and time-out was performed.The knee joint and surrounding structures were visualized with ultrasound.The site for the injection was properly marked and prepped with chlorhexidine solution.The injection site in the superior lateral pouch was anesthetized with ethyl chloride and 3cc of 1% lidocaine with a 25 gauge 1.5 inch needle.Using ultrasound guidance, the right knee joint was visualized and injected with hylan g-f 20, sodium hyaluronate using 21 gauge 1.5 inch needle and sterile technique.During injection, there was unrestricted flow and care was taken not to inject hyaluronan into the skin or subcutaneous tissues.A sterile band-aide was applied.Post-injection instructions were given regarding post-procedure care, when to follow up in clinic and what to expect from the procedure.The patient tolerated the injection well and was discharged without complication.Upon admission, patients blood pressure was 157/87 mmhg, pulse was 59 beats/min and she rated her bilateral knee pain 7 on a scale of 10.On (b)(6) 2017, patient reported to the clinic and stated that she had a reaction to the hylan g-f 20, sodium hyaluronate injection.She rated her knee pain 10 on a scale of 10 and mentioned it as the worst pain ever (latency: 2 days).This event was assessed as serious and required intervention.The patient was examined and it was assessed that this could be due to a side effect of hylan g-f 20, sodium hyaluronate causing pseudosepsis (latency: 2 days).This event was assessed as serious and required intervention.As a corrective treatment, patient was given medrol dosepak and was given a refill of percocet.Patient was advised to follow up if the symptoms failed to improve or worsened.On an unknown date in (b)(6) 2017, after the injection, patient had acute swelling and took anti-inflammatories and has significant pain on the left knee as well as the right.Patient had not been able to do usual activities like go to church because of this pain (latency: unknown; seriousness as disability).She received the hylan g-f 20, sodium hyaluronate injections that had possible contamination and received a certified letter explaining the possibility of an injection.On (b)(6) 2018, patient reported for follow up visit due to increased pain after injections.Upon examination of her right knee, no effusion was noted.Action taken: not applicable corrective treatment: medrol dosepak, anti-inflammatories and percocet for pseudosepsis; outcome: not recovered for worst pain ever/increased pain after injections; unknown for rest of the events.An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.
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Event Description
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Not been able to do usual activities like go to church because of this pain [activities of daily living impaired] device malfunction [device malfunction] pseudosepsis [pseudosepsis] ([arthralgia aggravated], [swelling of r knee]) case narrative: this case was linked to case (b)(4) (multiple devices, left knee) initial information received on 28-oct-2019 from united states regarding an unsolicited valid legal serious case received from a lawyer.This case involves a 54 years old female patient (162.6 cm and 137 kg) who experienced pseudosepsis (latency: 2 days), not been able to do usual activities like go to church because of this pain (latency: unknown) while she was treated with with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was also added for the identified recalled lot.Patients medical history included hyperlipidemia, depression, migraine, left ventricular hypertrophy, irritable bowel syndrome, plantar fasciitis, achilles tendinitis, iron deficiency anemia, bells palsy, nocturnal leg cramps, panic attacks, cervical dysplasia, pregnancy with four children, mammogram on (b)(6) 2012, colonoscopy on (b)(6) 2013, excision benign skin lesion back on (b)(6) 2016, knee arthroscopy right, tonsillectomy, caregiver stress in (b)(6) 2012, bronchitis in (b)(6) 2012.Patients ongoing history included asthma since (b)(6) 2013, chronic right-sided low back pain with sciatica since (b)(6) 2013, degenerative joint disease of knee since (b)(6) 2013, allergic to almonds which resulted in swelling, allergic to remezon which resulted in anxiety, hypertension, chronic narcotic use since (b)(6) 2013, lower extremity edema since (b)(6) 2013, continuous use of opioids, bilateral knee pain since (b)(6) 2014, never smoked, allergic to advair diskus which resulted in rash on tongue, genu varum since (b)(6) 2014, benign recurrent vertigo since (b)(6) 2015, obesity morbid since (b)(6) 2015, chronic pain since (b)(6) 2016, primary osteoarthritis of left knee since (b)(6) 2016, primary osteoarthritis of right knee since (b)(6) 2016, allergic reaction to amoxicillin which resulted in rash, no alcohol use.Past vaccination history included influenza in (b)(6) 2016, (b)(6) 2013, (b)(6) 2014, (b)(6) 2015, (b)(6) 2016, (b)(6) 2017 and tdap on (b)(6) 2011.Past family history included hypertension (mother, sister and brother), coronary artery disease (mother), pancreatic cancer (father), asthma (father, sister and brother), diabetes type 2 (sister, paternal grandmother and maternal aunt), colon cancer (maternal aunt), liver cancer (maternal aunt).Concomitant medications included bupropion hydrochloride (wellbutrin); clonazepam (klonopin); diclofenac (voltaren [diclofenac]); eletriptan hydrobromide (relpax); lisinopril dihydrate (prinivil); macrogol 3350 (miralax); dexamethasone (deltasone [dexamethasone]); beclometasone dipropionate (qvar); salmeterol xinafoate (serevent); gabapentin (neurontin); hyoscyamine sulfate (anaspaz) for muscle spasms; ibuprofen (advil [ibuprofen]) for pain; loratadine (claritin [loratadine]); naloxone hydrochloride (narcan); promethazine (phenergan [promethazine]) for nausea; cyclobenzaprine hydrochloride (flexeril [cyclobenzaprine hydrochloride]) for muscle spasms; salbutamol sulfate (ventolin hfa) for wheezing; and salbutamol (proventil [salbutamol]).On (b)(6) 2017, patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at dosage 6ml, frequency once in right knee (batch: 7rsl021) for primary osteoarthritis of right knee.After the risks and benefits of the procedure were explained, consent was given, and time-out was performed.The knee joint and surrounding structures were visualized with ultrasound.The site for the injection was properly marked and prepped with chlorhexidine solution.The injection site in the superior lateral pouch was anesthetized with ethyl chloride and 3cc of 1% lidocaine with a 25 gauge 1.5 inch needle.Using ultrasound guidance, the right knee joint was visualized and injected with hylan g-f 20, sodium hyaluronate using 21 gauge 1.5 inch needle and sterile technique.During injection, there was unrestricted flow and care was taken not to inject hyaluronan into the skin or subcutaneous tissues.A sterile band-aide was applied.Post-injection instructions were given regarding post-procedure care, when to follow up in clinic and what to expect from the procedure.The patient tolerated the injection well and was discharged without complication.Upon admission, patients blood pressure was 157/87 mmhg, pulse was 59 beats/min and she rated her bilateral knee pain 7 on a scale of 10.On (b)(6) 2017, patient reported to the clinic and stated that she had a reaction to the hylan g-f 20, sodium hyaluronate injection.She rated her knee pain 10 on a scale of 10 and mentioned it as the worst pain ever (latency: 2 days).This event was assessed as serious and required intervention.The patient was examined and it was assessed that this could be due to a side effect of hylan g-f 20, sodium hyaluronate causing pseudosepsis (latency: 2 days).This event was assessed as serious and required intervention.As a corrective treatment, patient was given medrol dosepak and was given a refill of percocet.Patient was advised to follow up if the symptoms failed to improve or worsened.On an unknown date in (b)(6) 2017, after the injection, patient had acute swelling and took anti-inflammatories and has significant pain on the left knee as well as the right.Patient had not been able to do usual activities like go to church because of this pain (latency: unknown; seriousness as disability).She received the hylan g-f 20, sodium hyaluronate injections that had possible contamination and received a certified letter explaining the possibility of an injection.On (b)(6) 2018, patient reported for follow up visit due to increased pain after injections.Upon examination of her right knee, no effusion was noted.Action taken: not applicable for all events.Corrective treatment: medrol dosepak, anti-inflammatories and percocet for pseudosepsis.Outcome: not recovered for worst pain ever/increased pain after injections; unknown for rest of the events.A product technical complaint was initiated on 08-nov-2019 for synvisc one (lot number 7rsl021) with global ptc number (b)(4).An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from 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.An investigation ((b)(4)) was performed and capas were identified with timelines for implementation of these capas.The final investigation was completed on 14-nov-2019.Follow up information was received on 08-nov-2019 from healthcare professional.No significant information was received.Additional information was received on 14-nov-2019 from other healthcare professional.Global ptc number was added.Text amended accordingly.
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Search Alerts/Recalls
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