| Lot Number 7RSL021 |
| Device Problem
Microbial Contamination of Device (2303)
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| Patient Problem
No Code Available (3191)
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| Event Date 11/28/2017 |
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Event Type
Injury
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Event Description
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Right knee pseudoseptic reaction after synvisc injection [pseudosepsis] ([difficulty in standing], [device malfunction], [joint range of motion decreased], [aching (r) knee], [pain upon movement], [swelling of r knee], [weight bearing difficulty], [pain in leg]).Bun (blood urea nitrogen) high [blood urea nitrogen increased].Coughing up yellow phlegm [phlegm discoloured].Coughing [coughing].Chest was starting to hurt [chest ache].Case narrative: initial information received on 28-jan-2020 from united states regarding an unsolicited valid legal serious case received from a lawyer.This case involves a (b)(6) years old female patient who experienced right knee pseudoseptic reaction after synvisc injection, bun (blood urea nitrogen) high, coughing up yellow phlegm, coughing, chest was starting to hurt, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added for the identified recall lot.The patient's past medical history included total left knee replacement in (b)(6) 2017, callus of foot, pure hypercholesterolemia, unspecified, moderate persistent asthma with acute exacerbation, small cell b-cell lymphoma, actinic keratosis, depression, leg pain, right, spinal stenosis, squamous cell carcinoma in situ of skin of face, tubular adenoma of colon, colonoscopy with polyp/biopsy on (b)(6) 2015, debridement upper extremity on (b)(6) 2010, elbow fracture surgery on (b)(6) 2013, carpal tunnel release on (b)(6) 2006 and (b)(6) 2005, node biopsy on (b)(6) 2011, sclerotherapy single vein on (b)(6) 2005, tonsillectomy, tubal ligation open and venous access insertion.The patient's past vaccination(s) included flu vaccine on (b)(6) 2017, (b)(6) 2016, (b)(6) 2015, (b)(6) 2014, (b)(6) 2013; influenza vaccine on (b)(6) 2011, (b)(6) 2007; pneumococcal conj pcv13 on (b)(6) 2015, pneumococcal polysaccharide ppsv23 on (b)(6) 2015; tdap on (b)(6) 2015; td(adult) preservative free on (b)(6) 2005 and zoster on (b)(6) 2016.At the time of the event, the patient had ongoing allergy to mango which caused rash since (b)(6) 2012, toe pain, chronic, left, walker for ambulation, right knee pain, presence of left artificial knee joint, insomnia, keratoacanthoma, exogenous obesity, osteoarthritis, impaired fasting glucose, focal bronchiectasis, hypogammaglobulinaemia, igg deficiency, inflammatory arthritis since (b)(6) 2013, chronic low back pain, chronic bronchitis, right knee djd, never smoker and recurrent varicose veins.Family history included chronic obstructive pulmonary disease (father), breast cancer (mother), cancer (not otherwise listed) (maternal grandfather, sister, daughter), diabetes (paternal grandmother), asthma (grandchild).Concomitant medications included salbutamol (proventil) for dyspnoea, wheezing and cough; paracetamol (tylenol); aspirin [acetylsalicylic acid]; tramadol hydrochloride (ultram); docusate sodium, sennoside a+b (senokot s); salbutamol (albuterol hfa); azelastine hydrochloride (astelin); cyanocobalamin (cyanocobalamin); calcium carbonate, famotidine, magnesium hydroxide (pepcid complete); fexofenadine hydrochloride (allegra); fluticasone propionate, salmeterol xinafoate (advair); betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); calcium phosphate dibasic, lactobacillus acidophilus (probiotic acidophilus); urea (carmol); montelukast sodium (singulair); xantofyl, zeaxanthin (lutein zeaxanthin); calcium carbonate, colecalciferol (caltrate + vitamin d); fish oil; fluticasone propionate (flonase), cpap/bipap therapy and vitamin d3.On (b)(6) 2017, patient stated that her right knee was causing her more pain again.Patient had a cortisone injection done at the time of her surgery, but this had already worn off.Patient elected to receive hylan g-f 20, sodium hyaluronate.On (b)(6) 2017 around 3 pm, patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at dosage 6 ml, frequency once in her right knee (batch: 7rsl021, exp may-2020) for osteoarthritis of right knee, unspecified osteoarthritis type.A sterile prep of the knee was done using chlorhexidine.The right knee was injected with 6 ml of synvisc one using sterile technique.The superolateral portal site was utilized.The patient tolerated the procedure well without complications.She did feel lightheaded following the injection but recovered quickly with a few sips of water.Post injection pain management and what to watch for reviewed.Patient was instructed to continue with the home exercise program to improve range of motion and strength.Patient was told to continue full weight-bearing and she advance with walking and other smooth, low impact activities as tolerated.She would continue the use of oxycodone ir and hydrocodone to manage her pain.She stated that she had hydrocodone at home and would try it.Patient was suggested to take aleve to see if this would help with her pain.Patient was told to follow up in 6 weeks.The same day, patient reported to the emergency department and complained of right leg pain after having an injection.Patient denied any trauma to her leg and said it hurt over and over.Around 8pm, she was resting in a recliner when patient began to develop severe knee pain, rated it 15/10 which was abrupt in onset.Pain had been continuous since the onset.Patient's daughter called around 09:30 pm and mentioned that patient tried elevating the knee, ice, heat but had no relief.Patient took two oxycodone tabs, did not help.The patient presented to the er around 11:30 pm with family members to assist.Er completed labs and x-ray which appear negative.She had 4mg of morphine followed by a repeat 4mg dose about 45 minutes later.The patient states this did not help.Family said she appeared more comfortable than prior.Patient was uncomfortably shifting in bed and intermittently crying out in pain.Patient said her pain worse with movement, she was unable to bear weight, described pain as burning and her rt knee swollen but had no erythema, urticaria or dyspnea.Patient was able to move toes and had good sensation in her foot.Patient stated that she had excruciating pain in the right knee, could not stand on it and could not bend it.She reported that it was hurting 4 times more than the knee that had surgery.On (b)(6) 2017, patient presented to the emergency room and was admitted to the hospital for pain management due to severe knee pain which began after receiving the injection.X-ray was not suggestive of effusion, labs were unremarkable.Case was discussed with ortho and patient was admitted for pain management.As a corrective, patient given ibuprofen (motrin) and methylprednisolone (medrol dosepak).She was diagnosed with right knee pseudoseptic reaction after synvisc injection (latency: unknown) (onset: (b)(6) 2017).She was started on methylprednisolone (medrol dosepak) with hydrocodone, tramadol, oxycodone and ibuprofen.She progressed with physical therapy.Same day, lab results revealed bun (blood urea nitrogen) high (latency: 1 day) at 21.On (b)(6) 2017, rated her pain a 6 on a 1-10 scale.She reports that she can lift her leg but was unable to bear weight due to pain.She had been able to get up in room.On (b)(6) 2017, patient was discharged.Patient was able to sit in chair and perform self respiratory treatment.She stated her pain had significantly lessened and she planned to stay with family.She reported she did not require supplemental oxygen with her cpap last night during her overnight oximetry study.Upon discharge, patient was advised to visit 1 to 2 times a day for 5 to 7 days for her physical therapy sessions.On (b)(6) 2017, patient reported for her physical therapy session.On (b)(6) 2017, during follow up of her history of leg pain and recurrent varicose veins.Patient had undergone a previous sclero in 2005.The patient had new varices and some increasing pain and it was planned to obtain a bilateral lower extremity venous reflux study.Patient was told to return in a week.The imaging results revealed no evidence of deep venous thrombosis or superficial thrombophlebitis.On (b)(6) 2017, patient reported for follow up of her asthma and had moderate persistent asthma with acute exacerbation.On (b)(6) 2017, patient called for results of venous reflux and was told that she would have to undergo gsv closure.Patient was planning to get her right knee repaired as well in or around march.On (b)(6) 2017, patient reported that her knee pain was back to what it was prior to the injection but was not the severe pain that she had experienced immediately following the injection.She stated also that she was progressing very well with the total knee on the opposite side and was working with warm water therapy on this.She was pleased with her progress.Patient was informed that she had been administered the injection from recall lot and the physician would wish to examine her knee in the clinic.On (b)(6) 2017, patient reported for follow up.There appeared to be no evidence of septic arthritis of the right knee.Patient stated her knee had been bothering since she had the injection.She states the swelling has gone since then.She rated her pain a 2/10.She stated her left tka pain was a 4/10.She would continue her usual management for her arthritic knee and continue her involvement with appropriate exercises and activities as she recovers from her left total knee arthroplasty.Patient was told to report in 1 month to check her progress.Patient was considering right total knee arthroplasty in the spring.On (b)(6) 2017, patient reported for follow up of her varicose veins, bilateral lower extremity, swelling, left leg worse than the right.Doppler studies showed only mild deep venous insufficiency of the left common femoral vein.The left leg had some just focal insufficiency of the distal lesser saphenous vein.Patient reported her right knee was very painful.Patient had been wearing a brace every day this week and it hurt to step on it.Her pain had increased from last week, however, nothing like the pain i had when admitted after the injection.On (b)(6) 2017, patients esr and crp were normal and so no signs of infection were noted.Patient was told to continue conservative treatment of the knee pain with ice, knee brace and use of a walker as needed.On (b)(6) 2017, patient followed up for moderate persistent asthma with acute exacerbation.On (b)(6) 2018, patient followed up for chronic pain of right knee and was having some neuropathic type pain in her knee which was keeping her up at night.On (b)(6) 2018, patient followed up portacath flush.On (b)(6) 2018, patient had been coughing (latency: 1 month 13 days) for 2 days and it's that deep cough again, she was coughing up yellow phlegm (latency: 1 month 13 days) and her chest was starting to hurt (latency: 1 month 13 days).As a corrective, patient took an extra nebulizer treatment in addition to her therapy vest with nebulizer.On (b)(6) 2018, patient contacted the clinic for follow up on her prednisolone dosing.On (b)(6) 2018, patient reported she was still coughing some but it was clear now and she was much better.Action taken: not applicable for all events.Corrective treatment: methylprednisolone (medrol dosepak), ice, heat, oxycodone, hydrocodone, tramadol, ibuprofen (motrin), physical therapy, elevation, morphine for pseudoseptic reaction after synvisc injection; nebulizer for coughing up yellow phlegm, coughing; not reported for rest.Outcome: recovered/resolved for coughing up yellow phlegm; recovering/resolving for right knee pseudoseptic reaction after synvisc injection; unknown for rest.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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Right knee pseudoseptic reaction after synvisc injection [pseudosepsis].[difficulty in standing], [device malfunction], [joint range of motion decreased], [aching (r) knee], [pain upon movement], [swelling of r knee], [weight bearing difficulty], [pain in leg].Bun (blood urea nitrogen) high [blood urea nitrogen increased].Coughing up yellow phlegm [phlegm discoloured], coughing [coughing].Chest was starting to hurt [chest ache].Case narrative: initial information received on 28-jan-2020 from united states regarding an unsolicited valid legal serious case received from a lawyer.This case involves a 75 years old female patient who experienced right knee pseudoseptic reaction, after synvisc injection, bun (blood urea nitrogen) high, coughing up yellow phlegm, coughing, chest was starting to hurt, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added for the identified recall lot.The patient's past medical history included: total left knee replacement in (b)(6) 2017, callus of foot, pure hypercholesterolemia, unspecified, moderate persistent asthma with acute exacerbation, small cell b-cell lymphoma, actinic keratosis, depression, leg pain, right, spinal stenosis, squamous cell carcinoma in situ of skin of face, tubular adenoma of colon, colonoscopy with polyp/biopsy on (b)(6) 2015, debridement upper extremity on (b)(6) 2010, elbow fracture surgery on (b)(6) 2013, carpal tunnel release on (b)(6) 2006 and (b)(6) 2005, node biopsy on (b)(6) 2011, sclerotherapy single vein on (b)(6) 2005, tonsillectomy, tubal ligation open and venous access insertion.The patient's past vaccination(s) included flu vaccine on (b)(6) 2017, (b)(6) 2016, (b)(6) 2015, (b)(6) 2014, (b)(6) 2013; influenza vaccine on (b)(6) 2011, (b)(6) 2007; pneumococcal conj pcv13 on (b)(6) 2015, pneumococcal polysaccharide ppsv23 on (b)(6) 2015; tdap on (b)(6) 2015; td(adult) preservative free on (b)(6) 2005 and zoster on (b)(6) 2016.At the time of the event, the patient had ongoing allergy to mango, which caused rash since (b)(6) 2012.Toe pain, chronic, left walker for ambulation, right knee pain, presence of left artificial knee joint, insomnia, keratoacanthoma, exogenous obesity, osteoarthritis, impaired fasting glucose, focal bronchiectasis, hypogammaglobulinaemia, igg deficiency, inflammatory arthritis since (b)(6) 2013, chronic low back pain, chronic bronchitis, right knee djd, never smoker and recurrent varicose veins.Family history included: chronic obstructive pulmonary disease (father), breast cancer (mother), cancer (not otherwise listed) (maternal grandfather, sister, daughter), diabetes (paternal grandmother), asthma (grandchild) concomitant medications included: salbutamol (proventil) for dyspnoea, wheezing and cough; paracetamol (tylenol); aspirin [acetylsalicylic acid]; tramadol hydrochloride (ultram); docusate sodium, sennoside a+b (senokot s); salbutamol (albuterol hfa); azelastine hydrochloride (astelin); cyanocobalamin (cyanocobalamin); calcium carbonate, famotidine, magnesium hydroxide (pepcid complete); fexofenadine hydrochloride (allegra); fluticasone propionate, salmeterol xinafoate (advair); betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); calcium phosphate dibasic, lactobacillus acidophilus (probiotic acidophilus); urea (carmol); montelukast sodium (singulair); xantofyl, zeaxanthin (lutein zeaxanthin); calcium carbonate, colecalciferol (caltrate + vitamin d); fish oil; fluticasone propionate (flonase), cpap/bipap therapy and vitamin d3.On (b)(6) 2017, patient stated, that that her right knee was causing her more pain again.Patient had a cortisone injection done at the time of her surgery, but this had already worn off.Patient elected to receive hylan g-f 20, sodium hyaluronate.On (b)(6) 2017 around 3 pm, patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at dosage 6 ml, frequency once in her right knee (batch: 7rsl021, exp 31-may-2020) for osteoarthritis of right knee.Unspecified osteoarthritis type.A sterile prep of the knee was done using chlorhexidine.The right knee was injected with 6 ml of synvisc one using sterile technique.The superolateral portal site was utilized.The patient tolerated the procedure well without complications.She did feel lightheaded following the injection, but recovered quickly with a few sips of water.Post injection pain management and what to watch for reviewed.Patient was instructed to continue with the home exercise program to improve range of motion and strength.Patient was told to continue full weight-bearing.And she advance with walking and other smooth, low impact activities as tolerated.She would continue the use of oxycodone ir and hydrocodone to manage her pain.She stated, that she had hydrocodone at home and would try it.Patient was suggested to take aleve to see if this would help with her pain.Patient was told to follow up in 6 weeks.The same day, patient reported, to the emergency department and complained of right leg pain after having an injection.Patient denied any trauma to her leg and said it hurt over and over.Around 8pm, she was resting in a recliner when patient began to develop severe knee pain, rated it 15/10.Which was abrupt in onset.Pain had been continuous since the onset.Patient's daughter called around 09:30 pm and mentioned, that patient tried elevating the knee, ice, heat, but had no relief.Patient took two oxycodone tabs, did not help.The patient presented to the er around 11:30 pm with family members to assist.Er completed labs and x-ray which appear negative.She had 4mg of morphine followed by a repeat 4mg dose about 45 minutes later.The patient states, this did not help.Family said she appeared more comfortable than prior.Patient was uncomfortably shifting in bed and intermittently crying out in pain.Patient said her pain worse with movement.She was unable to bear weight, described pain as burning and her rt knee swollen, but had no erythema, urticaria or dyspnea.Patient was able to move toes and had good sensation in her foot.Patient stated, that she had excruciating pain in the right knee, could not stand on it and could not bend it.She reported, that it was hurting 4 times more than the knee that had surgery.On (b)(6) 2017, patient presented to the emergency room and was admitted to the hospital for pain management, due to severe knee pain which began after receiving the injection.X-ray was not suggestive of effusion, labs were unremarkable.Case was discussed with ortho and patient was admitted for pain management.As a corrective, patient given ibuprofen (motrin) and methylprednisolone (medrol dosepak).She was diagnosed with right knee pseudoseptic reaction after synvisc injection (latency: unknown) (onset: (b)(6) 2017).She was started, on methylprednisolone (medrol dosepak) with hydrocodone, tramadol, oxycodone and ibuprofen.She progressed with physical therapy.Same day, lab results revealed bun (blood urea nitrogen) high (latency: 1 day) at 21.On (b)(6) 2017, rated her pain a 6 on a 1-10 scale.She reports that she can lift her leg, but was unable to bear weight, due to pain.She had been able to get up in room.On (b)(6) 2017, patient was discharged.Patient was able to sit in chair and perform self respiratory treatment.She stated, her pain had significantly lessened and she planned to stay with family.She reported she did not require supplemental oxygen with her cpap last night, during her overnight oximetry study.Upon discharge, patient was advised to visit 1 to 2 times a day for 5 to 7 days for her physical therapy sessions.On (b)(6) 2017, patient reported for her physical therapy session.On 07-dec-2017, during follow up of her history of leg pain and recurrent varicose veins.Patient had undergone a previous sclero in 2005.The patient had new varices and some increasing pain and it was planned to obtain a bilateral lower extremity venous reflux study.Patient was told to return in a week.The imaging results revealed no evidence of deep venous thrombosis or superficial thrombophlebitis.On 08-dec-2017, patient reported for follow up of her asthma and had moderate persistent asthma with acute exacerbation.On (b)(6) 2017, patient called for results of venous reflux and was told that she would have to undergo gsv closure.Patient was planning to get her right knee repaired as well in or around march.On (b)(6) 2017, patient reported that her knee pain was back to what it was prior to the injection, but was not the severe pain that she had experienced immediately following the injection.She stated, also that she was progressing very well with the total knee on the opposite side and was working with warm water therapy on this.She was pleased with her progress.Patient was informed, that she had been administered the injection from recall lot and the physician would wish to examine her knee in the clinic.On 14-dec-2017, patient reported for follow up.There appeared to be no evidence of septic arthritis of the right knee.Patient stated, her knee had been bothering since she had the injection.She states, the swelling has gone since then.She rated her pain a 2/10.She stated, her left tka pain was a 4/10.She would continue her usual management for her arthritic knee.And continue her involvement with appropriate exercises and activities as she recovers from her left total knee arthroplasty.Patient was told to report in 1 month to check her progress.Patient was considering right total knee arthroplasty in the spring.On (b)(6) 2017, patient reported for follow up of her varicose veins, bilateral lower extremity, swelling, left leg worse than the right.Doppler studies showed only mild deep venous insufficiency of the left common femoral vein.The left leg had some just focal insufficiency of the distal lesser saphenous vein.Patient reported her right knee was very painful.Patient had been wearing a brace every day this week and it hurt to step on it.Her pain had increased from last week.However, nothing like the pain i had when admitted after the injection.On 22-dec-2017, patients esr and crp were normal and so no signs of infection were noted.Patient was told to continue conservative treatment of the knee pain with ice, knee brace and use of a walker as needed.On (b)(6) 2017, patient followed up for moderate persistent asthma with acute exacerbation.On (b)(6) 2018, patient followed up for chronic pain of right knee and was having some neuropathic type pain in her knee, which was keeping her up at night.On (b)(6) 2018, patient followed up portacath flush.On (b)(6) 2018, patient had been coughing (latency: 1 month 13 days) for 2 days and it's that deep cough again, she was coughing up yellow phlegm (latency: 1 month 13 days) and her chest was starting to hurt (latency: 1 month 13 days).As a corrective, patient took an extra nebulizer treatment in addition to her therapy vest with nebulizer.On (b)(6) 2018, patient contacted the clinic for follow up on her prednisolone dosing.On (b)(6) 2018, patient reported she was still coughing some but it was clear now and she was much better.Action taken: not applicable for all events.Corrective treatment: methylprednisolone (medrol dosepak), ice, heat, oxycodone, hydrocodone, tramadol, ibuprofen (motrin), physical therapy, elevation, morphine for pseudoseptic reaction after synvisc injection.Nebulizer for coughing up yellow phlegm, coughing.Not reported for rest of the events.Outcome: recovered/resolved for coughing up yellow phlegm.Recovering/resolving for right knee pseudoseptic reaction after synvisc injection.Unknown for rest of the events.A product technical complaint was initiated on 28-jan-2020 for synvisc-one.Batch number: 7rsl021, 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.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Final investigation complete date: 04-mar-2020.Follow up information received on 30-jan-2020 from other healthcare professional.Global ptc number added.Text amended accordingly.Additional information received on 04-mar-2020 from other healthcare professional.Suspect product expiration date added.Investigation results completion date added.Clinical course updated.Text amended accordingly.
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