| Lot Number 7RSL021 |
| Device Problem
Nonstandard Device (1420)
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| Patient Problems
Arthritis (1723); Contusion (1787); Ecchymosis (1818); Erythema (1840); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
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Event Type
Injury
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Event Description
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Device malfunction [device malfunction].Could not walk/limping [walking difficulty].Missed a lot of work/loss of personal independence in daily activities [activities of daily living impaired].She was sitting down [difficulty in standing].Unable to bear any weight at all [weight bearing difficulty].Pain with squatting, kneeling and crouching [pain upon movement].Baker's cyst in right knee [baker's cyst].Neutrophil percentage high [neutrophil percentage increased].White blood cell count high [white blood cell count high].Neutrophil count high [neutrophil count high].Monocyte count increased [monocyte count increased].Fibrin d dimer high [fibrin d dimer high].Synovial fluid cloudy [synovial fluid analysis abnormal].Arthritis in both knees, worse on left around knee cap [knee arthritis] ([joint warmth] [swelling of knees], [knee pain], [knee effusion], [joint range of motion decreased], [erythema]).Case narrative: based on additional information received on 31-jul-2018 from a physician, the case was medically confirmed.Also overall reporter causality was updated from not reported to related and company causality was updated from not reportable to reportable.Initial information received from united states on (b)(6) 2018 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and on the same day missed a lot of work/loss of personal independence in daily activities, she was sitting down, unable to bear any weight at all, after 1 day could not walk/limping, after 13 days had baker's cyst in right knee, after 15 days had arthritis in both knees, worse on left around knee cap, after unknown latency had pain with squatting, kneeling and crouching; after 5 days neutrophil percentage high, synovial fluid cloudy; and after 13 days white blood cell count high, neutrophil count high, monocyte count increased and fibrin d dimer high.Also the reported lot number had device malfunction.The patient had initial onset of left knee pain (arthralgia) in 1993, after she slipped on a slippery floor, which resulted in a significant left knee injury.She had left knee arthroscopic surgery in 1993, but it never resulted in pain free function of the knee.The knee had progressively become more painful.She was having trouble with both knees.She stated that the right knee had gotten 'stuck in 90 degrees of flexion' in the past.The left knee was not just painful, but also she felt a sense of instability.She could not walk for long periods of time.Patient was allergic to drugs: doxycycline and scopolamine (reaction: nausea).Patient's other medical history/ concurrent conditions included: depression, cough, frequent urinary tract infection, pap smear abnormal (1999), benign left breast lump (diagnosed on (b)(6) 2006), lasik surgery, tricompartmental degenerative joint disease of both knees, left greater than right, mild narrowing of the lateral compartment of the left knee without significant change, patella alta, moderate joint effusion, small baker's cyst, chondromalacia of left knee, bilateral patellofemoral osteoarthritis, possible meniscal pathology of left knee and history of pseudo septic reaction to synvisc 1 injection.Patient was a non- smoker and was a alcohol user with 3 glasses of wine (1.8 oz)/ week or 1 alcoholic beverage per day.The patient's past medical history included having cortisone injections (which resulted in a severe reaction where the knees got acutely painful and red) years prior to the synvisc one injection and synvisc one injections at least twice before and patient believes that she had the three-injection series before that.Patient had received antibiotics, alleve, ibuprofen and levonorgestrel (mirena) (replaced iud) in the past.Concomitant medications included codeine phosphate, guaifenesin (guaifenesin ac) and benzonatate (tessalon perle) for cough, methylprednisolone (medrol dosepak), azithromycin (zithromax), bupropion hydrochloride (wellbutrin), ciprofloxacin (cipro), spironolactone (aldactone), escitalopram oxalate (lexapro) and clindamycin phosphate (clindagel).On (b)(6) 2017, at 02:00 pm, the patient was administered intra-articular synvisc one 1 df 1x intra-articular (lot - 7rsl021) in both her knees for knee pain after receiving a sterile chlorhexidine prep and 2 cc of lidocaine.Patient tolerated the procedure well.Patient felt great for the first 6 hours.After that, patient's knees blew up like footballs.By 08:00, patient's knee starting to hurt.Two hours later, patient could not put pressure on any knee, could not straighten legs at all, could not drive home.It was also reported that the patient could not even lift her leg to get out of bed to go to the bathroom.Also, before the injections patient was able to walk and her pain level was 1 out of 10; however, after receiving injections her pain level was 10 out of 10.After five or six hours approximately, she experienced her knees swelling / knees swelled to the size of football/left was worse than right.Inflammation had diminished on right side but not as much as on left side.On the same day, patient had loss of personal independence in daily activities, had dysstasia and weight bearing difficulty.No fever was reported.Patient reported that she had a lot of pain/ pain level was 10 out of 10, missed a lot of work.Patient tried to get out of bed and could not.Patient got to couch and iced.On an unknown date, after unknown latency, patient had pain with squatting, kneeling and crouching.On (b)(6) 2017, patient could not walk and became a walking aid user had to use crutches for at least five days until she finally saw a doctor.It was very hard getting into bed and painful cause any movement of legs hurt.On (b)(6) 2017, patient's right knee was feeling better and could finally put pressure on it.Swelling of right knee was going down but the left knee swelling was still huge.As of (b)(6) 2017, patient's pain was still about 9 on left leg but right knee was still getting better.On (b)(6) 2017, patient had follow up visit for bilateral knee pain, left greater than right.Pain level was about 6 when moving.On examination of both knees, patient had clear side to side difference with moderate effusion on the left side.There was mild warmth and mild erythema.Range of motion was from 0-90 degree on the left with pain.Effusion on the right side had improved spontaneously.Patient's left knee was aspirated for 50 cc of yellow cloudy fluid and was sent for synovial fluid analysis as well as gram stain and culture.Patient's nucleated cell count was 13896.Patient would begin oral cipro 500 mg twice a day.It was reported that the fluid did not look infected but suspicious.The fluid had no aerobic or anaerobic bacterial growth.Patient still had a hope that this was an inflammatory infection.Ice and ibuprofen were used as treatment but patient was relieved only after getting fluid removed.On an unknown date, patient saw the physician and it was reported that she was no longer using crutches, swelling was going down but she was still in pain and was much better now.It was reported that the patient had no prosthesis and was not being treated for any chronic diseases including diabetes and she had no allergies to birds, feathers or eggs.On (b)(6) 2017, patient's neutrophil percentage was 83 % (high) (reference: 0-25) and synovial fluid was cloudy.By (b)(6) 2017, patient's cell count was at 13000.It was elevated but not as high as most knee infections.Patient could put weight on both legs, but was still limping but much better.Pain was about 4 when walking.On (b)(6) 2017, results were negative for infection, still swollen.As of (b)(6) 2017, patient was using ice and ibuprofen, but was still painful and limping, and could not walk far or do stairs.On (b)(6) 2017, patient had a follow up visit.Physician thought that it was an inflammatory reaction to shot and would go away.It was reported that patient's both knees continued to give her trouble but the left was giving her more trouble than the right.On examination, patient's left knee had a mild-moderate effusion.This was much smaller of an effusion that she lad last week.Range of motion was from a few degrees shy of extension to flexion of 100 degree.Examination of right knee revealed a mild effusion with full motion and minimal joint line.On (b)(6) 2017, patient had x-ray of left knee for chronic left knee pain that demonstrated development of a moderate effusion, tricompartmental osteophytes and moderate lateral patellar subluxation with bony scalloping and remodeling in the lateral patellar facet articulating with the lateral trochlea.X-ray demonstrated significant progression of osteoarthritis involving the patellofemoral joint.On (b)(6) 2017, patient had magnetic resonance imaging (mri) of knee joint with contrast left and there was large joint effusion.Baker's cyst seen previously had decreased slightly in the interval.There was progression of chondromalacia change involving the medial and to a lesser extent the lateral compartments of the knee.On the same day, patient had mri of knee joint with contrast right.There was progression of patellofemoral cartilage loss as well as progression of cartilage loss involving the lateral compartment and to lesser extent the medial compartment of knee.There was a moderate joint effusion with interval development of baker's cyst.There was a suspected loose body along the posterior medial aspect of the lateral femoral condyle.On (b)(6) 2017, patient's white blood cell count was 13.2 k/mcl (high) (reference: 4.2 - 11.0), neutrophil count was 9.7 k/mcl (high) (reference: 1.8-7.7), monocyte count was 1.0 k/mcl (high) (reference: 0.3-0.9) and fibrin d dimer was 0.60 mg/l (high) (reference: <0.57).On (b)(6) 2017, mri showed that there was arthritis in both knees.Worse on left around knee cap.Labs were clear of infections.Also reported that the patient was not able to go back to regular exercise until (b)(6) 2018.Treatment: ibuprofen, naproxen sodium (aleve), ice for she was sitting down, unable to bear any weight at all, pain with squatting, kneeling and crouching; ibuprofen, ice and cipro for arthritis, crutches for could not walk/limping, not reported for other events.Outcome: recovering/ resolving for missed a lot of work/loss of personal independence in daily activities, device malfunction, could not walk/limping, unable to bear any weight at all, unknown for arthritis in both knees, pain with squatting, kneeling and crouching, worse on left around knee cap, baker's cyst, neutrophil percentage high, white blood cell count high, neutrophil count high, monocyte count increased, synovial fluid cloudy and fibrin d dimer high; recovered/resolved for other events.A pharmaceutical technical compliant was initiated on 11-jul-2018 for synvisc one (lot number: 7rsl021) with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: disability for could not walk/limping and device malfunction.Additional information was received on 11-jul-2018.Global ptc number and results were added.Text was amended accordingly.Additional information was received on 31-jul-2018 from a physician.The case was medically confirmed.Reporter and company causality of a lot of pain/ pain level was 10 out of 10 had to be carried around until she got crutches, missed a lot of work, she was sitting down, unable to bear any weight at all, could not even lift her leg to get out of bed to go to the bathroom, had to have it removed from the knees/ fluid was removed from the knees, her knees swelling / knees swelled to the size of football/left was worse than right and device malfunction was updated from not reported to related and not reportable to reportable respectively.Additional event of pain with squatting, kneeling and crouching, could not walk/limping, arthritis in both knees, worse on left around knee cap and baker's cyst in right knee were added.The event had to be carried around until she got crutches was updated as symptom of could not walk/limping.Event term missed a lot of work was updated to missed a lot of work/loss of personal independence in daily activities and event onset date was added.Event onset dates of she was sitting down, unable to bear any weight at all were added.Events could not even lift her leg to get out of bed to go to the bathroom/could not put pressure on any knee, could not straighten legs at all, her knees swelling / knees swelled to the size of football/left was worse than right, had a lot of pain/ pain level was 10 out of 10/starting to hurt, had to have it removed from the knees/ fluid was removed from the left knee were updated as symptoms of arthritis in both knees, worse on left around knee cap.Laboratory test results were added.Outcome and seriousness criteria of device malfunction was updated.Therapy date of synvisc one were added.Clinical course was updated and text was amended accordingly.Additional information was received on 28-aug-2018 from a physician.Additional events of neutrophil percentage high, white blood cell count high, neutrophil count high, monocyte count increased, synovial fluid cloudy and fibrin d dimer high were added with details.Medical history, concomitant medications, corrective treatments and laboratory results added.Clinical course was updated and text was amended accordingly.
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Event Description
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Device malfunction [device malfunction] could not walk/limping [walking difficulty] missed a lot of work/loss of personal independence in daily activities [activities of daily living impaired] she was sitting down [difficulty in standing] unable to bear any weight at all [weight bearing difficulty] pain with squatting, kneeling and crouching [pain upon movement] baker's cyst in right knee [baker's cyst] neutrophil percentage high [neutrophil percentage increased] white blood cell count high [white blood cell count high] neutrophil count high [neutrophil count high] monocyte count increased [monocyte count increased] bruise beneath her left knee [bruise] slight ecchymosis over left patellar region [ecchymosis] fibrin d dimer high [fibrin d dimer high] sore throat [sore throat] worsened [condition aggravated] synovial fluid cloudy [synovial fluid analysis abnormal] pseudo-septic reaction bilaterally but far worse on the left than the right [pseudosepsis] ([joint warmth], [swelling of knees], [knee pain], [joint range of motion decreased], [knee arthritis], [erythema], [effusion (l) knee]) case narrative: initial information received from united states on 10-jul-2018 regarding an unsolicited valid serious legal case received from a consumer/non-hcp.This case involves a 46 years old female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and on the same day missed a lot of work/loss of personal independence in daily activities, she was sitting down, unable to bear any weight at all, after 1 day could not walk/limping, after 2 days slight ecchymosis over the left patellar tendon, after 13 days had baker's cyst in right knee, after unknown latency had pseudo-septic reaction bilaterally but far worse on the left than the right, after unknown latency had pain with squatting, kneeling and crouching and bruise beneath her left knee; after 5 days neutrophil percentage high, synovial fluid cloudy; and after 13 days white blood cell count high, neutrophil count high, monocyte count increased and fibrin d dimer high and after 7 months 17 days had sore throat.Also the reported lot number had device malfunction.The patient had initial onset of left knee pain (arthralgia) in 1993, after she slipped on a slippery floor, which resulted in a significant left knee injury.She had left knee arthroscopic surgery in 1992 and 1993, but it never resulted in pain free function of the knee.Patient had chronic discomfort, swelling, grinding, stiffness, pain worsening with activities.The knee had progressively become more painful.She was having trouble with both knees.She stated that the right knee had gotten 'stuck in 90 degrees of flexion' in the past, had difficulty with range of motion.The left knee was not just painful, but also she felt a sense of instability.The pain was worse with sitting and had sensation of instability of right leg.She could not walk for long periods of time.Patient was allergic to drugs: doxycycline and scopolamine (reaction: nausea).Patient's other medical history/ concurrent conditions included: depression, cough, frequent urinary tract infection, pap smear abnormal (1999), benign left breast lump (diagnosed on (b)(6) 2006), lasik surgery, tricompartmental degenerative joint disease of both knees, left greater than right, mild narrowing of the lateral compartment of the left knee without significant change, patella alta, moderate joint effusion (small effusion in right knee), small baker's cyst, moderate chondromalacia of patellofemoral joint, chondromalacia of left knee, bilateral patellofemoral osteoarthritis, possible meniscal pathology of left knee, degenerative changes of lateral and patellofemoral compartments of left knee.Patient was a non- smoker and was a alcohol user with 3 glasses of wine (1.8 oz)/ week or 1 alcoholic beverage per day.The patient's past medical history included having intermittent cortisone injections (which resulted in a severe reaction where the knees got acutely painful and red) years prior to the synvisc one injection and synvisc one injections at least twice before and patient believes that she had the three-injection series before that.Patient had received antibiotics, alleve, ibuprofen and levonorgestrel (mirena) (replaced iud) in the past.Concomitant medications included codeine phosphate, guaifenesin (guaifenesin ac) and benzonatate (tessalon perle) for cough, methylprednisolone (medrol dosepak), azithromycin (zithromax), bupropion hydrochloride (wellbutrin), ciprofloxacin (cipro), spironolactone (aldactone), escitalopram oxalate (lexapro) and clindamycin phosphate (clindagel), tramamdol hydrochloride (ultram).Patient's mammogram showed no malignancy in past.Reported history of shoulder pain and was having physical therapy for it which got worse and patient had trouble doing overhead activities and was injected with depomedrol.Patient had history of fatigue and depression (fall of 2012), eye surgery, blood in stool ((b)(6) 2014), rectal bleeding and spotting ((b)(6) 2014), dizziness (b)(6) 2014), was positive for hearing loss, had flu like symptoms (positive for congestion, sore throat, rhinorrhea, postnasal drip and sinus pressure, cough), general body aches, nausea, dysphagia, dysuria, acne vulgaris, mild degenerative disc disease in the thoracic spine, anxiety (started in (b)(6) 2016), allergic conjunctivitis and rhinitis, recurrent acute maxillary sinusitis, recurrent rhinosinusitis, urinary urgency, abdominal tenderness and frequency, bee sting on (b)(6) 2017 on inner left thigh; looked swollen and inflamed and had rash.Patient had right foot and posterior ankle pain.She reported twisting her foot, causing pain up the posterior ankle no swelling, no redness or warmth.Patient had history of lower leg osteoarthritis.Family history included hypertension (mother), arthritis (mother), diabetes (maternal grandmother and maternal grandfather, maternal uncle), depression, high blood pressure and high cholesterol (father).Patient had cortisone injection to both knees on (b)(6) 2014, and by next day both knees were buckling with the right knee worse and could barely walk, right leg became numb, swollen, red and hot.On (b)(6) 2015, patient had esophagogastroduodenoscopy for odynophagia which showed superficial ulceration 32 cm most consistent with pill ulceration, again on(b)(6) 2016, showed pill ulcer/esophagitis, gastritis and on 11-sep2-16, showed healed esophageal ulcer.On an unknow date in 2016, patient fell down flight of stairs, hit head, and is having left shoulder pain.On (b)(6) 2017, at 02:00 pm, the patient was administered intra-articular synvisc one 1 df 1x intra-articular (lot - 7rsl021) in both her knees for knee pain after receiving a sterile chlorhexidine prep and 2 cc of lidocaine.Patient tolerated the procedure well.Patient felt great for the first 6 hours.After that, patient's knees blew up like footballs.By 08:00, patient's knee starting to hurt.Two hours later, patient could not put pressure on any knee, could not straighten legs at all, could not drive home.It was also reported that the patient could not even lift her leg to get out of bed to go to the bathroom.Also, before the injections patient was able to walk and her pain level was 1 out of 10 however, after receiving injections her pain level was 10 out of 10.After five or six hours approximately, she experienced her knees swelling / knees swelled to the size of football/left was worse than right.Inflammation had diminished on right side but not as much as on left side.On the same day, patient had loss of personal independence in daily activities, had dysstasia and weight bearing difficulty.No fever was reported.Patient reported that she had a lot of pain/ pain level was 10 out of 10, missed a lot of work.Patient tried to get out of bed and could not.Patient got to couch and iced.On an unknown date, after unknown latency, patient had pain with squatting, kneeling and crouching.On (b)(6) 2017, patient could not walk and became a walking aid user had to use crutches for at least five days until she finally saw a doctor.It was very hard getting into bed and painful cause any movement of legs hurt.On an unknown date in (b)(6) 2017, the patient had developed intense pain in both knees and a bruise benaeth her left knee that she did not had before.Doctor advised ice and elevation and reported that this procedure was too advanced.The patient had been using ibuprofen with any benefit.On (b)(6) 2017, the patient took oxycodone on morning that did not help.Further her family was coming this christmas and she was concerned that she would not be able to attend the parties.It also reported that left knee pain was worse mostly in anterior and posterior.Patient got relief with percocet taken this morning.The physical examination revealed slight ecchymosis over the left patellar tendon.On (b)(6) 2017, patient's right knee was feeling better and could finally put pressure on it.Swelling of right knee was going down but the left knee swelling was still huge.As of (b)(6) 2017, patient's pain was still about 9 on left leg but right knee was still getting better.On (b)(6) 2017, patient had follow up visit for bilateral knee pain, left greater than right.Pain level was about 6 when moving.On examination of both knees, patient had clear side to side difference with moderate effusion on the left side.There was mild warmth and mild erythema.Range of motion was from 0-90 degree on the left with pain.Effusion on the right side had improved spontaneously.Patient's left knee was aspirated for 50 cc of yellow cloudy fluid and was sent for synovial fluid analysis as well as gram stain and culture.Patient's nucleated cell count was 13896.Patient would begin oral cipro 500 mg twice a day.It was reported that the fluid did not look infected but suspicious.The fluid had no aerobic or anaerobic bacterial growth.Patient still had a hope that this was an inflammatory infection.Ice and ibuprofen were used as treatment but patient was relieved only after getting fluid removed.On an unknown date, patient saw the physician and it was reported that she was no longer using crutches, swelling was going down but she was still in pain and was much better now.It was reported that the patient had no prosthesis and was not being treated for any chronic diseases including diabetes and she had no allergies to birds, feathers or eggs.On (b)(6) 2017, patient's neutrophil percentage was 83 % (high)(reference: 0-25) and synovial fluid was cloudy.By (b)(6) 2017, patient's cell count was at 13000.It was elevated but not as high as most knee infections.Patient could put weight on both legs, but was still limping but much better.Pain was about 4 when walking.On (b)(6) 2017, results were negative for infection, still swollen.As of (b)(6) 2017, patient was using ice and ibuprofen, but was still painful and limping, and could not walk far or do stairs.On (b)(6) 2017, patient had a follow up visit.Physician thought that it was an inflammatory reaction to shot and would go away.It was reported that patient's both knees continued to give her trouble but the left was giving her more trouble than the right.On examination, patient's left knee had a mild-moderate effusion.This was much smaller of an effusion that she lad last week.Range of motion was from a few degrees shy of extension to flexion of 100 degree.Examination of right knee revealed a mild effusion with full motion and minimal joint line.On (b)(6) 2017, patient had x-ray of left knee for chronic left knee pain that demonstrated development of a moderate effusion, tricompartmental osteophytes and moderate lateral patellar subluxation with bony scalloping and remodeling in the lateral patellar facet articulating with the lateral trochlea.X-ray demonstrated significant progression of osteoarthritis involving the patellofemoral joint.It was reported that patient has excretion of osteoarthritis and pseudo-septic reaction bilaterally but far worse on the left than the right (latency: unknown).On (b)(6) 2017, patient had magnetic resonance imaging (mri) of knee joint with contrast left and there was large joint effusion.Baker's cyst seen previously had decreased slightly in the interval.There was progression of chondromalacia change involving the medial and to a lesser extent the lateral compartments of the knee.On the same day, patient had mri of knee joint with contrast right.There was progression of patellofemoral cartilage loss as well as progression of cartilage loss involving the lateral compartment and to lesser extent the medial compartment of knee.There was a moderate joint effusion with interval development of baker's cyst.There was a suspected loose body along the posterior medial aspect of the lateral femoral condyle.On (b)(6) 2017, patient's white blood cell count was 13.2 k/mcl (high)(reference: 4.2 - 11.0), neutrophil count was 9.7 k/mcl (high)(reference: 1.8-7.7), monocyte count was 1.0 k/mcl (high)(reference: 0.3-0.9) and fibrin d dimer was 0.60 mg/l (high)(reference: <0.57).On (b)(6) -2017, mri showed that there was arthritis in both knees.Worse on left around knee cap.Labs were clear of infections.On (b)(6) 2018, patient recovered from unable to bear any weight at all.On the unknown date of (b)(6) 2018, patient recovered from limping.On the unknown date of(b)(6) 2018, patient recovered from loss of personal independence in daily activities.Also reported that the patient was not able to go back to regular exercise until (b)(6) 2018.On (b)(6) 2018, patient had pap smear which was normal.On (b)(6) 2018 patient had sore throat, which has worsened (nights and mornings are worse) (latency: 7 months 17 days).Treatment: ibuprofen, naproxen sodium (aleve), ice for she was sitting down, unable to bear any weight at all, pain with squatting, kneeling and crouching; ibuprofen, ice and cipro for arthritis, crutches for could not walk/limping, icing for burise beneath her left knee; not reported for other events.Outcome: recovering/ resolving for device malfunction; unknown for pseudo-septic reaction bilaterally but far worse on the left than the right, burise beneath her left knee, slight ecchymosis over the left patellar tendon, pain with squatting, kneeling and crouching, worse on left around knee cap, baker's cyst, neutrophil percentage high, white blood cell count high, neutrophil count high, monocyte count increased, synovial fluid cloudy and fibrin d dimer high; recovered/resolved for missed a lot of personal independence in daily activities, could not walk/limping and unable to bear any weight at all and rest of other events.A pharmaceutical technical compliant was initiated on (b)(6) 2018 for synvisc one (lot number: 7rsl021) with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled adverse events received from the us market for synvisc one lot 7rsl021.The product met all release testing at time of manufacture in (b)(6) 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.Seriousness criteria: disability for could not walk/limping and device malfunction additional information was received on 11-jul-2018.Global ptc number and results were added.Text was amended accordingly.Additional information was received on 31-jul-2018 from a physician.The case was medically confirmed.Reporter and company causality of a lot of pain/ pain level was 10 out of 10 had to be carried around until she got crutches, missed a lot of work, she was sitting down, unable to bear any weight at all, could not even lift her leg to get out of bed to go to the bathroom, had to have it removed from the knees/ fluid was removed from the knees, her knees swelling / knees swelled to the size of football/left was worse than right and device malfunction was updated from not reported to related and not reportable to reportable respectively.Additional event of pain with squatting, kneeling and crouching, could not walk/limping, arthritis in both knees, worse on left around knee cap and baker's cyst in right knee were added.The event had to be carried around until she got crutches was updated as symptom of could not walk/limping.Event term missed a lot of work was updated to missed a lot of work/loss of personal independence in daily activities and event onset date was added.Event onset dates of she was sitting down, unable to bear any weight at all were added.Events could not even lift her leg to get out of bed to go to the bathroom/could not put pressure on any knee, could not straighten legs at all, her knees swelling / knees swelled to the size of football/left was worse than right, had a lot of pain/ pain level was 10 out of 10/starting to hurt, had to have it removed from the knees/ fluid was removed from the left knee were updated as symptoms of arthritis in both knees, worse on left around knee cap.Laboratory test results were added.Outcome and seriousness criteria of device malfunction was updated.Therapy date of synvisc one were added.Clinical course was updated and text was amended accordingly.Additional information was received on 28-aug-2018 from a patient.Additional events of neutrophil percentage high, white blood cell count high, neutrophil count high, monocyte count increased, synovial fluid cloudy and fibrin d dimer high were added with details.Medical history, concomitant medications, corrective treatments and laboratory results added.Clinical course was updated, and text was amended accordingly.Follow-up information was received on 28-sep-2018 from the patient.No new information was added.Additional information was received on 23-oct-2018 from the patient.Outcome for missed a lot of personal independence in daily activities, could not walk/limping and unable to bear any weight at all updated to recovered from recovering.Clinical course updated, and text amended accordingly.Additional information was received on 02-nov-2018 from lawyer.Classification of the case updated.Race and ethnicity was added.Event of burise beneath her left knee and slight ecchymosis over the left patellar tendon was added.Clinical course updated, and text amended accordingly.Upon internal review the medically confirmed status of the case updated.Additional information was received on 27-dec-2018.Medical history was updated.Concomitant medication were updated.Events of pseudo-septic reaction bilaterally but far worse on the left than the right and sore throat were added.Clinical course updated.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction] could not walk/limping [walking difficulty] missed a lot of work/loss of personal independence in daily activities [activities of daily living impaired] she was sitting down [difficulty in standing] unable to bear any weight at all [weight bearing difficulty] pain with squatting, kneeling and crouching [pain upon movement] baker's cyst in right knee [baker's cyst] neutrophil percentage high [neutrophil percentage increased] white blood cell count high [white blood cell count high] neutrophil count high [neutrophil count high] monocyte count increased [monocyte count increased] fibrin d dimer high [fibrin d dimer high] synovial fluid cloudy [synovial fluid analysis abnormal] arthritis in both knees, worse on left around knee cap [knee arthritis] ([joint warmth], [swelling of knees], [knee pain], [effusion (l) knee], [joint range of motion decreased], [erythema]).Case narrative: based on additional information received on 31-jul-2018 from a physician, the case was medically confirmed.Also, overall reporter causality was updated from not reported to related and company causality was updated from not reportable to reportable.Initial information received from united states on 10-jul-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 46 years old female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and on the same day missed a lot of work/loss of personal independence in daily activities, she was sitting down, unable to bear any weight at all, after 1 day could not walk/limping, after 13 days had baker's cyst in right knee, after 15 days had arthritis in both knees, worse on left around knee cap, after unknown latency had pain with squatting, kneeling and crouching; after 5 days neutrophil percentage high, synovial fluid cloudy; and after 13 days white blood cell count high, neutrophil count high, monocyte count increased and fibrin d dimer high.Also the reported lot number had device malfunction.The patient had initial onset of left knee pain (arthralgia) in 1993, after she slipped on a slippery floor, which resulted in a significant left knee injury.She had left knee arthroscopic surgery in 1993, but it never resulted in pain free function of the knee.The knee had progressively become more painful.She was having trouble with both knees.She stated that the right knee had gotten 'stuck in 90 degrees of flexion' in the past.The left knee was not just painful, but also she felt a sense of instability.She could not walk for long periods of time.Patient was allergic to drugs: doxycycline and scopolamine (reaction: nausea).Patient's other medical history/ concurrent conditions included: depression, cough, frequent urinary tract infection, pap smear abnormal (1999), benign left breast lump (diagnosed on (b)(6) 2006), lasik surgery, tricompartmental degenerative joint disease of both knees,left greater than right, mild narrowing of the lateral compartment of the left knee without significant change, patella alta, moderate joint effusion, small baker's cyst, chondromalacia of left knee, bilateral patellofemoral osteoarthritis, possible meniscal pathology of left knee and history of pseudo septic reaction to synvisc 1 injection.Patient was a non- smoker and was a alcohol user with 3 glasses of wine (1.8 oz)/ week or 1 alcoholic beverage per day.The patient's past medical history included having cortisone injections (which resulted in a severe reaction where the knees got acutely painful and red) years prior to the synvisc one injection and synvisc one injections at least twice before and patient believes that she had the three-injection series before that.Patient had received antibiotics, alleve, ibuprofen and levonorgestrel (mirena) (replaced iud) in the past.Concomitant medications included codeine phosphate, guaifenesin (guaifenesin ac) and benzonatate (tessalon perle) for cough, methylprednisolone (medrol dosepak), azithromycin (zithromax), bupropion hydrochloride (wellbutrin), ciprofloxacin (cipro), spironolactone (aldactone), escitalopram oxalate (lexapro) and clindamycin phosphate (clindagel).On (b)(6) 2017, at 02:00 pm, the patient was administered intra-articular synvisc one 1 df 1x intra-articular (lot - 7rsl021) in both her knees for knee pain after receiving a sterile chlorhexidine prep and 2 cc of lidocaine.Patient tolerated the procedure well.Patient felt great for the first 6 hours.After that, patient's knees blew up like footballs.By 08:00, patient's knee starting to hurt.Two hours later, patient could not put pressure on any knee, could not straighten legs at all, could not drive home.It was also reported that the patient could not even lift her leg to get out of bed to go to the bathroom.Also, before the injections patient was able to walk and her pain level was 1 out of 10 however, after receiving injections her pain level was 10 out of 10.After five or six hours approximately, she experienced her knees swelling / knees swelled to the size of football/left was worse than right.Inflammation had diminished on right side but not as much as on left side.On the same day, patient had loss of personal independence in daily activities, had dysstasia and weight bearing difficulty.No fever was reported.Patient reported that she had a lot of pain/ pain level was 10 out of 10, missed a lot of work.Patient tried to get out of bed and could not.Patient got to couch and iced.On an unknown date, after unknown latency, patient had pain with squatting, kneeling and crouching.On (b)(6) 2017, patient could not walk and became a walking aid user had to use crutches for at least five days until she finally saw a doctor.It was very hard getting into bed and painful cause any movement of legs hurt.On (b)(6) 2017, patient's right knee was feeling better and could finally put pressure on it.Swelling of right knee was going down but the left knee swelling was still huge.As of (b)(6) 2017, patient's pain was still about 9 on left leg but right knee was still getting better.On (b)(6) 2017, patient had follow up visit for bilateral knee pain, left greater than right.Pain level was about 6 when moving.On examination of both knees, patient had clear side to side difference with moderate effusion on the left side.There was mild warmth and mild erythema.Range of motion was from 0-90 degree on the left with pain.Effusion on the right side had improved spontaneously.Patient's left knee was aspirated for 50 cc of yellow cloudy fluid and was sent for synovial fluid analysis as well as gram stain and culture.Patient's nucleated cell count was 13896.Patient would begin oral cipro 500 mg twice a day.It was reported that the fluid did not look infected but suspicious.The fluid had no aerobic or anaerobic bacterial growth.Patient still had a hope that this was an inflammatory infection.Ice and ibuprofen were used as treatment but patient was relieved only after getting fluid removed.On an unknown date, patient saw the physician and it was reported that she was no longer using crutches, swelling was going down but she was still in pain and was much better now.It was reported that the patient had no prosthesis and was not being treated for any chronic diseases including diabetes and she had no allergies to birds, feathers or eggs.On (b)(6) 2017, patient's neutrophil percentage was 83 % (high)(reference: 0-25) and synovial fluid was cloudy.By (b)(6) 2017, patient's cell count was at 13000.It was elevated but not as high as most knee infections.Patient could put weight on both legs, but was still limping but much better.Pain was about 4 when walking.On (b)(6) 2017, results were negative for infection, still swollen.As of (b)(6) 2017, patient was using ice and ibuprofen, but was still painful and limping, and could not walk far or do stairs.On (b)(6) 2017, patient had a follow up visit.Physician thought that it was an inflammatory reaction to shot and would go away.It was reported that patient's both knees continued to give her trouble but the left was giving her more trouble than the right.On examination, patient's left knee had a mild-moderate effusion.This was much smaller of an effusion that she lad last week.Range of motion was from a few degrees shy of extension to flexion of 100 degree.Examination of right knee revealed a mild effusion with full motion and minimal joint line.On (b)(6) 2017, patient had x-ray of left knee for chronic left knee pain that demonstrated development of a moderate effusion, tricompartmental osteophytes and moderate lateral patellar subluxation with bony scalloping and remodeling in the lateral patellar facet articulating with the lateral trochlea.X-ray demonstrated significant progression of osteoarthritis involving the patellofemoral joint.On (b)(6) 2017, patient had magnetic resonance imaging (mri) of knee joint with contrast left and there was large joint effusion.Baker's cyst seen previously had decreased slightly in the interval.There was progression of chondromalacia change involving the medial and to a lesser extent the lateral compartments of the knee.On the same day, patient had mri of knee joint with contrast right.There was progression of patellofemoral cartilage loss as well as progression of cartilage loss involving the lateral compartment and to lesser extent the medial compartment of knee.There was a moderate joint effusion with interval development of baker's cyst.There was a suspected loose body along the posterior medial aspect of the lateral femoral condyle.On (b)(6) 2017, patient's white blood cell count was 13.2 k/mcl (high)(reference: 4.2 - 11.0), neutrophil count was 9.7 k/mcl (high)(reference: 1.8-7.7), monocyte count was 1.0 k/mcl (high)(reference: 0.3-0.9) and fibrin d dimer was 0.60 mg/l (high)(reference: <0.57).On (b)(6) 2017, mri showed that there was arthritis in both knees.Worse on left around knee cap.Labs were clear of infections.On (b)(6) -2018, patient recovered from unable to bear any weight at all.On the unknown date of (b)(6) 2018, patient recovered from limping.On the unknown date of(b)(6) 2018, patient recovered from loss of personal independence in daily activities.Also reported that the patient was not able to go back to regular exercise until (b)(6) 2018.Treatment: ibuprofen, naproxen sodium (aleve), ice for she was sitting down, unable to bear any weight at all, pain with squatting, kneeling and crouching; ibuprofen, ice and cipro for arthritis, crutches for could not walk/limping, not reported for other events.Outcome: recovering/ resolving for device malfunction; unknown for arthritis in both knees, pain with squatting, kneeling and crouching, worse on left around knee cap, baker's cyst, neutrophil percentage high, white blood cell count high, neutrophil count high, monocyte count increased, synovial fluid cloudy and fibrin d dimer high; recovered/resolved for missed a lot of personal independence in daily activities, could not walk/limping and unable to bear any weight at all and rest of other events.A pharmaceutical technical compliant was initiated on (b)(6) 2018 for synvisc one (lot number: 7rsl021) with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: disability for could not walk/limping and device malfunction additional information was received on 11-jul-2018.Global ptc number and results were added.Text was amended accordingly.Additional information was received on 31-jul-2018 from a physician.The case was medically confirmed.Reporter and company causality of a lot of pain/ pain level was 10 out of 10 had to be carried around until she got crutches, missed a lot of work, she was sitting down, unable to bear any weight at all, could not even lift her leg to get out of bed to go to the bathroom, had to have it removed from the knees/ fluid was removed from the knees, her knees swelling / knees swelled to the size of football/left was worse than right and device malfunction was updated from not reported to related and not reportable to reportable respectively.Additional event of pain with squatting, kneeling and crouching, could not walk/limping, arthritis in both knees, worse on left around knee cap and baker's cyst in right knee were added.The event had to be carried around until she got crutches was updated as symptom of could not walk/limping.Event term missed a lot of work was updated to missed a lot of work/loss of personal independence in daily activities and event onset date was added.Event onset dates of she was sitting down, unable to bear any weight at all were added.Events could not even lift her leg to get out of bed to go to the bathroom/could not put pressure on any knee, could not straighten legs at all, her knees swelling / knees swelled to the size of football/left was worse than right, had a lot of pain/ pain level was 10 out of 10/starting to hurt, had to have it removed from the knees/ fluid was removed from the left knee were updated as symptoms of arthritis in both knees, worse on left around knee cap.Laboratory test results were added.Outcome and seriousness criteria of device malfunction was updated.Therapy date of synvisc one were added.Clinical course was updated and text was amended accordingly.Additional information was received on 28-aug-2018 from a physician.Additional events of neutrophil percentage high, white blood cell count high, neutrophil count high, monocyte count increased, synovial fluid cloudy and fibrin d dimer high were added with details.Medical history, concomitant medications, corrective treatments and laboratory results added.Clinical course was updated, and text was amended accordingly.Follow-up information was received on 28-sep-2018 from the patient.No new information was added.Additional information was received on 23-oct-2018 from the patient.Outcome for missed a lot of personal independence in daily activities, could not walk/limping and unable to bear any weight at all updated to recovered from recovering.Clinical course updated, and text amended accordingly.
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Event Description
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Device malfunction [device malfunction] could not walk/limping [walking difficulty] missed a lot of work/loss of personal independence in daily activities [activities of daily living impaired] she was sitting down [difficulty in standing] unable to bear any weight at all [weight bearing difficulty] pain with squatting, kneeling and crouching [pain upon movement] baker's cyst in right knee [baker's cyst] neutrophil percentage high [neutrophil percentage increased] white blood cell count high [white blood cell count high] neutrophil count high [neutrophil count high] monocyte count increased [monocyte count increased] bruise beneath her left knee [bruise] slight ecchymosis over left patellar region [ecchymosis] fibrin d dimer high [fibrin d dimer high] synovial fluid cloudy [synovial fluid analysis abnormal] arthritis in both knees, worse on left around knee cap [knee arthritis] ([joint warmth], [swelling of knees], [knee pain], [effusion (l) knee], [joint range of motion decreased], [erythema]).Case narrative: initial information received from united states on 10-jul-2018 regarding an unsolicited valid serious legal case received from a consumer/non-hcp.This case involves a 46 years old caucasian female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and on the same day missed a lot of work/loss of personal independence in daily activities, she was sitting down, unable to bear any weight at all, after 1 day could not walk/limping, after 2 days slight ecchymosis over the left patellar tendon, after 13 days had baker's cyst in right knee, after 15 days had arthritis in both knees, worse on left around knee cap, after unknown latency had pain with squatting, kneeling and crouching and burise beneath her left knee; after 5 days neutrophil percentage high, synovial fluid cloudy; and after 13 days white blood cell count high, neutrophil count high, monocyte count increased and fibrin d dimer high.Also the reported lot number had device malfunction.The patient had initial onset of left knee pain (arthralgia) in 1993, after she slipped on a slippery floor, which resulted in a significant left knee injury.She had left knee arthroscopic surgery in 1993, but it never resulted in pain free function of the knee.The knee had progressively become more painful.She was having trouble with both knees.She stated that the right knee had gotten 'stuck in 90 degrees of flexion' in the past.The left knee was not just painful, but also she felt a sense of instability.She could not walk for long periods of time.Patient was allergic to drugs: doxycycline and scopolamine (reaction: nausea).Patient's other medical history/ concurrent conditions included: depression, cough, frequent urinary tract infection, pap smear abnormal (1999), benign left breast lump (diagnosed on (b)(6) 2006), lasik surgery, tricompartmental degenerative joint disease of both knees,left greater than right, mild narrowing of the lateral compartment of the left knee without significant change, patella alta, moderate joint effusion, small baker's cyst, chondromalacia of left knee, bilateral patellofemoral osteoarthritis, possible meniscal pathology of left knee and history of pseudo septic reaction to synvisc 1 injection.Patient was a non- smoker and was a alcohol user with 3 glasses of wine (1.8 oz)/ week or 1 alcoholic beverage per day.The patient's past medical history included having cortisone injections (which resulted in a severe reaction where the knees got acutely painful and red) years prior to the synvisc one injection and synvisc one injections at least twice before and patient believes that she had the three-injection series before that.Patient had received antibiotics, alleve, ibuprofen and levonorgestrel (mirena) (replaced iud) in the past.Concomitant medications included codeine phosphate, guaifenesin (guaifenesin ac) and benzonatate (tessalon perle) for cough, methylprednisolone (medrol dosepak), azithromycin (zithromax), bupropion hydrochloride (wellbutrin), ciprofloxacin (cipro), spironolactone (aldactone), escitalopram oxalate (lexapro) and clindamycin phosphate (clindagel).On (b)(6) 2017, at 02:00 pm, the patient was administered intra-articular synvisc one 1 df 1x intra-articular (lot - 7rsl021) in both her knees for knee pain after receiving a sterile chlorhexidine prep and 2 cc of lidocaine.Patient tolerated the procedure well.Patient felt great for the first 6 hours.After that, patient's knees blew up like footballs.By 08:00, patient's knee starting to hurt.Two hours later, patient could not put pressure on any knee, could not straighten legs at all, could not drive home.It was also reported that the patient could not even lift her leg to get out of bed to go to the bathroom.Also, before the injections patient was able to walk and her pain level was 1 out of 10 however, after receiving injections her pain level was 10 out of 10.After five or six hours approximately, she experienced her knees swelling / knees swelled to the size of football/left was worse than right.Inflammation had diminished on right side but not as much as on left side.On the same day, patient had loss of personal independence in daily activities, had dysstasia and weight bearing difficulty.No fever was reported.Patient reported that she had a lot of pain/ pain level was 10 out of 10, missed a lot of work.Patient tried to get out of bed and could not.Patient got to couch and iced.On an unknown date, after unknown latency, patient had pain with squatting, kneeling and crouching.On (b)(6) 2017, patient could not walk and became a walking aid user had to use crutches for at least five days until she finally saw a doctor.It was very hard getting into bed and painful cause any movement of legs hurt.On an unknown date in (b)(6) 2017, the patient had developed intense pain in both knees and a bruise benaeth her left knee that she did not had before.Doctor advised ice and elevation and reported that this procedure was too advanced.The patient had been using ibuprofen with any benefit.On (b)(6) 2017, the patient took oxycodone on morning that did not help.Further her family was coming this christmas and she was concerned that she would not be able to attend the parties.It also reported that left knee pain was worse mostly in anterior and posterior.Patient got relief wiith percocet taken this morning.The physical examination revealed slight ecchymosis over the left patellar tendon.On (b)(6) 2017, patient's right knee was feeling better and could finally put pressure on it.Swelling of right knee was going down but the left knee swelling was still huge.As of (b)(6) 2017, patient's pain was still about 9 on left leg but right knee was still getting better.On (b)(6) 2017, patient had follow up visit for bilateral knee pain, left greater than right.Pain level was about 6 when moving.On examination of both knees, patient had clear side to side difference with moderate effusion on the left side.There was mild warmth and mild erythema.Range of motion was from 0-90 degree on the left with pain.Effusion on the right side had improved spontaneously.Patient's left knee was aspirated for 50 cc of yellow cloudy fluid and was sent for synovial fluid analysis as well as gram stain and culture.Patient's nucleated cell count was 13896.Patient would begin oral cipro 500 mg twice a day.It was reported that the fluid did not look infected but suspicious.The fluid had no aerobic or anaerobic bacterial growth.Patient still had a hope that this was an inflammatory infection.Ice and ibuprofen were used as treatment but patient was relieved only after getting fluid removed.On an unknown date, patient saw the physician and it was reported that she was no longer using crutches, swelling was going down but she was still in pain and was much better now.It was reported that the patient had no prosthesis and was not being treated for any chronic diseases including diabetes and she had no allergies to birds, feathers or eggs.On (b)(6) 2017, patient's neutrophil percentage was 83 % (high)(reference: 0-25) and synovial fluid was cloudy.By (b)(6) 2017, patient's cell count was at 13000.It was elevated but not as high as most knee infections.Patient could put weight on both legs, but was still limping but much better.Pain was about 4 when walking.On (b)(6) 2017, results were negative for infection, still swollen.As of (b)(6) 2017, patient was using ice and ibuprofen, but was still painful and limping, and could not walk far or do stairs.On (b)(6) 2017, patient had a follow up visit.Physician thought that it was an inflammatory reaction to shot and would go away.It was reported that patient's both knees continued to give her trouble but the left was giving her more trouble than the right.On examination, patient's left knee had a mild-moderate effusion.This was much smaller of an effusion that she lad last week.Range of motion was from a few degrees shy of extension to flexion of 100 degree.Examination of right knee revealed a mild effusion with full motion and minimal joint line.On (b)(6) 2017, patient had x-ray of left knee for chronic left knee pain that demonstrated development of a moderate effusion, tricompartmental osteophytes and moderate lateral patellar subluxation with bony scalloping and remodeling in the lateral patellar facet articulating with the lateral trochlea.X-ray demonstrated significant progression of osteoarthritis involving the patellofemoral joint.On(b)(6) 2017, patient had magnetic resonance imaging (mri) of knee joint with contrast left and there was large joint effusion.Baker's cyst seen previously had decreased slightly in the interval.There was progression of chondromalacia change involving the medial and to a lesser extent the lateral compartments of the knee.On the same day, patient had mri of knee joint with contrast right.There was progression of patellofemoral cartilage loss as well as progression of cartilage loss involving the lateral compartment and to lesser extent the medial compartment of knee.There was a moderate joint effusion with interval development of baker's cyst.There was a suspected loose body along the posterior medial aspect of the lateral femoral condyle.On (b)(6) 2017, patient's white blood cell count was 13.2 k/mcl (high)(reference: 4.2 - 11.0), neutrophil count was 9.7 k/mcl (high)(reference: 1.8-7.7), monocyte count was 1.0 k/mcl (high)(reference: 0.3-0.9) and fibrin d dimer was 0.60 mg/l (high)(reference: <0.57).On (b)(6) 2017, mri showed that there was arthritis in both knees.Worse on left around knee cap.Labs were clear of infections.On (b)(6) 2018, patient recovered from unable to bear any weight at all.On the unknown date of (b)(6) 2018, patient recovered from limping.On the unknown date of march 2018, patient recovered from loss of personal independence in daily activities.Also reported that the patient was not able to go back to regular exercise until mar-2018.Treatment: ibuprofen, naproxen sodium (aleve), ice for she was sitting down, unable to bear any weight at all, pain with squatting, kneeling and crouching; ibuprofen, ice and cipro for arthritis, crutches for could not walk/limping, icing for burise beneath her left knee; not reported for other events.Outcome: recovering/ resolving for device malfunction; unknown for arthritis in both knees, burise beneath her left knee, slight ecchymosis over the left patellar tendon, pain with squatting, kneeling and crouching, worse on left around knee cap, baker's cyst, neutrophil percentage high, white blood cell count high, neutrophil count high, monocyte count increased, synovial fluid cloudy and fibrin d dimer high; recovered/resolved for missed a lot of personal independence in daily activities, could not walk/limping and unable to bear any weight at all and rest of other events.A pharmaceutical technical compliant was initiated on (b)(6) 2018 for synvisc one (lot number: 7rsl021) with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: disability for could not walk/limping and device malfunction additional information was received on 11-jul-2018.Global ptc number and results were added.Text was amended accordingly.Additional information was received on 31-jul-2018 from a physician.The case was medically confirmed.Reporter and company causality of a lot of pain/ pain level was 10 out of 10 had to be carried around until she got crutches, missed a lot of work, she was sitting down, unable to bear any weight at all, could not even lift her leg to get out of bed to go to the bathroom, had to have it removed from the knees/ fluid was removed from the knees, her knees swelling / knees swelled to the size of football/left was worse than right and device malfunction was updated from not reported to related and not reportable to reportable respectively.Additional event of pain with squatting, kneeling and crouching, could not walk/limping, arthritis in both knees, worse on left around knee cap and baker's cyst in right knee were added.The event had to be carried around until she got crutches was updated as symptom of could not walk/limping.Event term missed a lot of work was updated to missed a lot of work/loss of personal independence in daily activities and event onset date was added.Event onset dates of she was sitting down, unable to bear any weight at all were added.Events could not even lift her leg to get out of bed to go to the bathroom/could not put pressure on any knee, could not straighten legs at all, her knees swelling / knees swelled to the size of football/left was worse than right, had a lot of pain/ pain level was 10 out of 10/starting to hurt, had to have it removed from the knees/ fluid was removed from the left knee were updated as symptoms of arthritis in both knees, worse on left around knee cap.Laboratory test results were added.Outcome and seriousness criteria of device malfunction was updated.Therapy date of synvisc one were added.Clinical course was updated and text was amended accordingly.Additional information was received on 28-aug-2018 from a patient.Additional events of neutrophil percentage high, white blood cell count high, neutrophil count high, monocyte count increased, synovial fluid cloudy and fibrin d dimer high were added with details.Medical history, concomitant medications, corrective treatments and laboratory results added.Clinical course was updated, and text was amended accordingly.Follow-up information was received on 28-sep-2018 from the patient.No new information was added.Additional information was received on 23-oct-2018 from the patient.Outcome for missed a lot of personal independence in daily activities, could not walk/limping and unable to bear any weight at all updated to recovered from recovering.Clinical course updated, and text amended accordingly.Additional information was received on 02-nov-2018 from lawyer.Classification of the case updated.Race and ethnicity was added.Event of burise beneath her left knee and slight ecchymosis over the left patellar tendon was added.Clinical course updated, and text amended accordingly.Upon internal review the medically confirmed status of the case updated.
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