MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Diarrhea (1811); Dyspnea (1816); Erythema (1840); Fall (1848); Fever (1858); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Dizziness (2194); Anxiety (2328); Arthralgia (2355); Malaise (2359); Palpitations (2467); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Event Description

Gram neg infection/e coli infection in bones of her knee [joint infection] ([condition aggravated], [sickness], [myalgia], [chills], [joint stiffness], [knee pain], [swelling of knees], [joint warmth], [weight bearing difficulty], [device malfunction], [injection site joint redness], [inflammation], [escherichia coli infection]), even walking is a chore right now/ hardly able to walk [difficulty in walking].Couldn't get out of bed [mobility decreased].Pain in her right leg from her toes to her hip [pain in leg].Knees are grinding now [unspecified disorder of knee joint].Can't stand long at all [difficulty in standing].Couldn't even cook for christmas [activities of daily living impaired].Flu symptoms [flu symptoms].Nauseated [nauseated].Weight gain [weight gain].Anxiety [anxiety] ([panic attacks], [difficulty sleeping]).Allergic reaction to something from surgery [surgical site reaction].Back spasms [muscle spasm].Back pain [back pain].Shoulder pain [shoulder pain].Eustachian tube dysfunction [eustachian tube dysfunction].Change in vision [abnormal vision].Chest pain [chest pain].Palpitations [palpitations].Shortness of breath [shortness of breath].Diarrhea [diarrhea].Difficulty urinating [urine incontinence].Muscle weakness [muscle weakness].Streaking [administration site streaking].Low grade fever [fever].Medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint tenderness].Medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint crepitation].Locking [joint lock].Small red spots [spot pigmented].Case narrative: based on information received on 06-sep-2018 from healthcare professional, this case initially processed as non-serious was upgraded to serious as seriousness criterion of medically significant was added.Further, this case became medically confirmed.This unsolicited case from united states was received on 26-dec-2017 from patient.This case involves a (b)(6) female patient ((b)(6)) who experienced gram neg infection/e coli infection in bones of her knee, couldn't get out of bed, pain in her right leg from her toes to her hip, knees are grinding now, can't stand long at all, even walking is a chore right now/ hardly able to walk, couldn't even cook for christmas, flu symptoms, nauseated, weight gain, anxiety, allergic reaction to something from surgery, back spasms, back pain, eustachian tube dysfunction, shoulder pain, change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating and muscle weakness, low grade fever/fever of around 100, small red spots, medial and lateral joint line tenderness, patellofemoral crepitus, locking and compression tenderness (latency: unknown), while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added.The patient's past medical history included rheumatoid arthritis, hypothyroidism on (b)(6) 2017, hypercholesterolemia on (b)(6) 2017, biopsy breast in 2013, vascular operation on (b)(6) 2017, thyroidectomy, mammogram on (b)(6) 2016 with another one in (b)(6) 2017, cholecystectomy in (b)(6) 1996, hysterectomy in (b)(6) 2017, ovarian mass, fibromyalgia, autoimmune disorder, osteoporosis, overweight.The patient's family history included breast cancer on (b)(6) 2014.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing hypertension, type 1 diabetes mellitus on (b)(6) 2016, type 2 diabetes mellitus on (b)(6) 2014, non-tobacco user and abstains from alcohol.Patient denied any allergies to avian proteins, feathers, or egg products.Concomitant medications included methotrexate (methotrexate) for rheumatoid arthritis; anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); and zolpidem (zolpidem).On (b)(6) 2017, the patient-initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number 7rsl021) for osteoarthritis in both her knees.Patient stated that right from the beginning she experienced adverse reactions, so she was not asked if she engaged in activities such as jogging or tennis soon after the injection.On an unknown date in 2017, after few days of receiving injection, patient was upset, and she stated that she experienced pain and swelling and "hot".Patient stated that during the first couple of days she experienced redness and swelling.On an unknown date in 2017, latency unknown, patient could not get out of bed and could not put weight on her knees.Patient stated that she was experiencing pain in her right leg from her toes to her hip and that she was experiencing pain behind her knees now.Patient states that she has ra (rheumatoid arthritis) so she was on pain medication, but the pain has been worse since she received the synvisc-one injections.Patient stated that she was using a pain cream as well and was wondering why after a week it was not better.Patient states that this was the fourth time she received the synvisc-one and she would receive it every 6 months.Patient stated that after 5 months she would be in pain, but she would have to wait another month before she could get it again since she has medicare.Patient stated that this did not happen the other three times she had the synvisc-one and it was bad.Patient stated that she could not even cook for christmas because she cannot stand long at all.Patient stated that even walking was a chore right now.Patient was also experiencing flu symptoms and was nauseated and sick.Patient stated that she would go to urgent care today.Patient stated that she did not want knee replacements which was why she was receiving the synvisc-one.Patient stated that the pain was unreal, and she cannot even go to the bathroom because her knees were grinding now.Patient stated that prior to this she was in good health and her pain was tolerable.On (b)(6) 2018, patient reported to the clinic and stated that she noticed some improvement after being put on cephalexin but still walks with moderate to severely antalgic gait and has lateral joint line tenderness and compression tenderness which she previously did not have.On (b)(6) 2018, patient reported to the clinic with the complaint of a gram negative infection (latency: unknown) and complained of chills, myalgias and bilateral knee pain.It was reported that synvisc one shot was due in (b)(6).On (b)(6) 2018, patient reported for follow up and reported that she still had significant pain and reported that she has a reaction every time she stops taking cipro.The patient was given bilateral corticosteroid injections in each knee for the same.Post injection instructions for icing and anti-inflammatories were prescribed.The patient further stated that she is in severe pain and feels debilitated by her condition.On (b)(6) 2018, patient again reported for a follow up for her infection and complained of anxiety (latency: unknown) and stated she had panic attacks and restless sleep due to the same.Further, the patient also presented with eustachian tube dysfunction and requested for the need of another prescription of antibiotics prescribed to her for the infection.On (b)(6) 2018, the patient underwent bilateral knee arthroscopies with debridement for her knee infection.The patient was brought to the operative room and was administered anesthesia and pre-operative antibiotics.Both the knees of the patient were prepped in sterile fashion.Two standard portal incisions were made with the scalpel, inferolateral for the inflow.The knee showed grade 3 changes of patellofemoral joint with full thickness cartilage defects along trochlear groove.The medial joint had bony eburnation and meniscus tear.The meniscus tear was removed.The biters and grabbers were used to ligamentum mucosum and other tissues.The knee was re-evaluated after thorough washing out.Each of the two incisions were closed with 3-0 nylon sutures.The knees were cleaned, and antibiotics were given.The patient was sent to recovery room in stable condition.The patient tolerated the procedure well.On (b)(6) 2018, patient developed fever of around 100 (latency: 7 months) and had small red spots (latency: 7 months).On (b)(6) 2018, patient reported to the clinic for follow up on her surgery and chronic problems and was evaluated extensively for her hypothyroidism, hypercholesterolemia and diabetes.The patient also reported having back pain (latency: unknown) and weight gain (latency: unknown) as a result of stopping her phentermine therapy.On (b)(6) 2018, patient reported that she is experiencing locking, swelling, weakness and tenderness.She further reported that she is using a cane now and is able to get around better.On (b)(6) 2018, patient reported to the clinic with the complaint of infection in the bones of her knees (latency: unknown) and that her culture had returned with e coli sensitive to doxy and bactrim.On (b)(6) 2018, the patient reported having allergic reaction to somethings from surgery (latency: unknown) and requested for an ear checkup and discuss regarding her medicare guidelines.Further, the patient complained of back spasms (latency: unknown).On (b)(6) 2018, patient reported for follow up on her surgery and stated that she felt sick if she did not take the antibiotics.On (b)(6) 2018, patient reported with the complaint of shoulder pain (latency: unknown) and back pain (latency: unknown).As a corrective for the same, patient was administered a steroid injection.Her right shoulder site was prepped with ethoh/ethy chlorice 1cc per 80 cc depomedrol and 1 cc each of marcaine/ 1% lidocaine was injected using a 27 gauge needle.The patient tolerated the procedure well and was given follow up care instructions.On an unknown date, after unknown latency, patient experienced change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness, muscle weakness.It was reported that after the injection, patient was hardly able to walk, had redness, swelling, streaking, limited activities.Corrective treatment: ciprofloxacin, corticosteroid injection, amoxicillin and cephalexine, bilateral knee arthroscopy and debridement for gram neg infection/e coli infection in bones of her knee; use cane and brace for even walking is a chore right now/ hardly able to walk; meloxicam (mobic) and nabumetone (relafen) for medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness; not reported for rest events outcome: not recovered for pain in her right leg from her toes to her hip and experienced pain/pain behind her knees now; unknown for rest events.Seriousness criterion: required intervention and medically significant for gram neg infection/e coli infection in bones of her knee; disability for even walking is a chore right now/ hardly able to walk, gram neg infection/e coli infection in bones of her knee.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.Follow up information was received on 03-jan-2018.No new information received.Additional information was received on 22-feb-2018.Investigation summary was added.Text was amended accordingly.Additional information received on 06-sep-2018 from healthcare professional.Case was upgraded to serious and seriousness criterion of intervention required and medically significant added for event gram neg infection/e coli infection in bones of her knee and the case became medically confirmed.Past medical history of hypothyroidism, hypercholesterolemia, biopsy breast, vascular surgery, thyroidectomy, mammogram, cholecystectomy, hysterectomy, ovarian mass, hypertension, type 1 diabetes mellitus, type 2 diabetes mellitus, non-tobacco user and abstains from alcohol.The patient's family history included breast cancer.Concomitant medications added including anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); and zolpidem (zolpidem).Suspect product lot number added.Events of gram neg infection/e coli infection in bones of her knee, eustachian tube dysfunction, anxiety, weight gain, muscle spasm, allergic reaction to something in surgery, shoulder pain, back pain added.Events of swelling, experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee, hot, couldn't put weight on her knees and redness made symptoms of gram neg infection/e coli infection in bones of her knee.Clinical course updated.Text amended accordingly.Additional information received on 11-sep-2018 from physician.Verbatim of even walking is a chore right now was updated to even walking is a chore right now/ hardly able to walk.Event of change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, low grade fever, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness and muscle weakness was added with details.Medical history updated.Additional information received on 14-sep-2018 from healthcare professional.Event of joint lock and small red spots added.Event verbatim updated for experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee to experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee/significant pain and corrective treatment of corticosteroid injection added.Seriousness criterion of disability added for gram neg infection/e coli infection in bones of her knee.Event verbatim updated for low grade fever to low grade fever/fever of around 100 and onset date added.Clinical course updated.Text amended accordingly.

Event Description

Device malfunction [device malfunction] gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis [osteomyelitis] ([weight bearing difficulty], [injection site joint redness], [myalgia], [chills], [knee pain], [swelling of knees], [joint stiffness], [joint warmth], [condition aggravated], [inflammation], [sickness], [escherichia coli infection]) even walking is a chore right now/ hardly able to walk [difficulty in walking] couldn't get out of bed [mobility decreased] pain in her right leg from her toes to her hip [pain in leg] knees are grinding now [unspecified disorder of knee joint] can't stand long at all [difficulty in standing] couldn't even cook for christmas [activities of daily living impaired] flu symptoms [flu symptoms] nauseated [nauseated] weight gain [weight gain] anxiety [anxiety] ([difficulty sleeping], [panic attacks]) allergic reaction to something from surgery [surgical site reaction] back spasms [muscle spasm] back pain [back pain] shoulder pain [shoulder pain] eustachian tube dysfunction [eustachian tube dysfunction] change in vision [abnormal vision] chest pain [chest pain] palpitations [palpitations] shortness of breath [shortness of breath] diarrhea [diarrhea] difficulty urinating [urine incontinence] muscle weakness [muscle weakness] streaking [administration site streaking] low grade fever [fever] medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint crepitation] locking [joint lock] small red spots [spot pigmented] constipation [constipation] bilateral medial meniscus tears [meniscus tear] baker's cyst [baker's cyst] medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint tenderness] case narrative: based on information received on 06-sep-2018 from healthcare professional, this case initially processed as non-serious was upgraded to serious as seriousness criterion of medically significant was added.Further, this case became medically confirmed.This unsolicited legal case from united states was received on 26-dec-2017 from patient.This case involves a 63 years old female patient who experienced gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis, couldn't get out of bed, pain in her right leg from her toes to her hip, knees are grinding now, can't stand long at all, even walking is a chore right now/ hardly able to walk, couldn't even cook for christmas, flu symptoms, nauseated, weight gain, anxiety, allergic reaction to something from surgery, back spasms, back pain, eustachian tube dysfunction, shoulder pain, change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating and muscle weakness, low grade fever/fever of around 100, small red spots, medial and lateral joint line tenderness, patellofemoral crepitus, locking and compression tenderness (latency: unknown), constipation, bilateral medial meniscus tears, baker's cyst in left knee while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added.The patient's past medical history included rheumatoid arthritis, hypothyroidism on (b)(6) 2017 , hypercholesterolemia on (b)(6) 2017 , biopsy breast in 2013, vascular operation on (b)(6) 2017 , thyroidectomy, mammogram on (b)(6) 2016 with another one in (b)(6) 2017 cholecystectomy in (b)(6) 1996, hysterectomy in (b)(6) 2017 ovarian mass, fibromyalgia, autoimmune disorder, osteoporosis, liver disorder, overweight, osteopenia, menopause, arthritis, thyroid disorder, cosmetic surgery in (b)(6) 1980, surgery with thyroid removal in (b)(6) 2001, hernia repair in (b)(6) 2005, foot surgery heel in (b)(6) 2005, haemorrhoid operation in (b)(6) 1980, cholecystectomy in (b)(6) 1998, caesarean section in (b)(6) 1980, caesarean section in (b)(6) 1985 and diabetes mellitus type 2, fall in 2007, breast conserving surgery and invasive ductal breast carcinoma.Concurrent conditions included chronic neck pain, low back pain, generalized myofascial and joint pain, chronic reflux esophagitis, obesity, numbness in hands and weakness.The patient's family history included breast cancer on (b)(6) 2014.Patient's father experienced cataract and essential hypertension.Her mother had ra, arthritis, breast cancer and essential hypertension.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing hypertension, type 1 diabetes mellitus on (b)(6) 2016, type 2 diabetes mellitus on (b)(6) 2014, non-tobacco user and abstains from alcohol.Patient denied any allergies to avian proteins, feathers, or egg products.Concomitant medications included methotrexate (methotrexate) for rheumatoid arthritis; anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); zolpidem tartrate (ambien); gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clonazepam (klonopin), atorvastatin calcium (lipitor), metformin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl), morphine sulfate, glucosamine chondroitin, zolpidem, folic acid and liraglutide (victoza).On (b)(6) 2017, the patient-initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number 7rsl021) for osteoarthritis in both her knees.Patient stated that right from the beginning she experienced adverse reactions, so she was not asked if she engaged in activities such as jogging or tennis soon after the injection.On an unknown date in 2017, after few days of receiving injection, patient was upset, and she stated that she experienced pain and swelling and "hot".Patient stated that during the first couple of days she experienced redness and swelling.On an unknown date in 2017, latency unknown, patient could not get out of bed and could not put weight on her knees.Patient stated that she was experiencing pain in her right leg from her toes to her hip and that she was experiencing pain behind her knees now.Patient states that she has ra (rheumatoid arthritis) so she was on pain medication, but the pain has been worse since she received the synvisc-one injections.Patient stated that she was using a pain cream as well and was wondering why after a week it was not better.Patient states that this was the fourth time she received the synvisc-one and she would receive it every 6 months.Patient stated that after 5 months she would be in pain, but she would have to wait another month before she could get it again since she has medicare.Patient stated that this did not happen the other three times she had the synvisc-one and it was bad.Patient stated that she could not even cook for christmas because she cannot stand long at all.Patient stated that even walking was a chore right now.Patient was also experiencing flu symptoms and was nauseated and sick.Patient stated that she would go to urgent care today.Patient stated that she did not want knee replacements which was why she was receiving the synvisc-one.Patient stated that the pain was unreal, and she cannot even go to the bathroom because her knees were grinding now.Patient stated that prior to this she was in good health and her pain was tolerable.On (b)(6) 2018, patient reported to the clinic and stated that she noticed some improvement after being put on cephalexin but still walks with moderate to severely antalgic gait and has lateral joint line tenderness and compression tenderness which she previously did not have.On (b)(6) 2018, patient reported to the clinic with the complaint of a gram negative infection (latency: unknown) and complained of chills, myalgias and bilateral knee pain.It was reported that synvisc one shot was due in may.On (b)(6) 2018, patient reported for follow up and reported that she still had significant pain and reported that she has a reaction every time she stops taking cipro.The patient was given bilateral corticosteroid injections in each knee for the same.Post injection instructions for icing and anti-inflammatories were prescribed.The patient further stated that she was in severe pain and feels debilitated by her condition.On (b)(6) 2018, patient again reported for a follow up for her infection and complained of anxiety (latency: unknown) and stated she had panic attacks and restless sleep due to the same.Further, the patient also presented with eustachian tube dysfunction and requested for the need of another prescription of antibiotics prescribed to her for the infection.On (b)(6) 2018, the patient underwent bilateral knee arthroscopies with debridement for her knee infection.She had "growths" on both knees and hence undergone arthroscopic surgery.The patient was brought to the operative room and was administered anesthesia and pre-operative antibiotics.Both the knees of the patient were prepped in sterile fashion.Two standard portal incisions were made with the scapel, inferolateral for the inflow.The knee showed grade 3 changes of patellofemoral joint with full thickness cartilage defects along trochlear groove.The medial joint had bony eburnation and meniscus tear.The meniscus tear was removed.The biters and grabbers were used to ligamnetum mucosum and other tissues.The knee was re-evaluated after thorough washing out.Each of the two incisions were closed with 3-0 nylon sutures.The knees were cleaned, and antibiotics were given.The patient was sent to recovery room in stable condition.The patient tolerated the procedure well.Post operatively nerve block procedure was performed bilaterally for pain control.The patient tolerated the procedure well.On (b)(6) 2018, the adequate culture was sample was collected from left knee.No growth was reported.On (b)(6) 2018, patient developed fever of around 100 (latency: 7 months) and had small red spots (latency: 7 months).On (b)(6) 2018, patient reported to the clinic for follow up on her surgery and chronic problems and was evaluated extensively for her hypothyroidism, hypercholesterolemia and diabetes.The patient also reported having back pain (latency: unknown) and weight gain (latency: unknown) as a result of stopping her phentermine therapy.On (b)(6) 2018, patient reported that she is experiencing locking, swelling, weakness and tenderness.She further reported that she is using a cane now and is able to get around better.On (b)(6) 2018, patient reported to the clinic with the complaint of infection in the bones of her knees (latency: unknown) and that her culture had returned with e coli sensitive to doxy and bactrim.On (b)(6) 2018, the patient reported having allergic reaction to somethings from surgery (latency: unknown) and requested for an ear checkup and discuss regarding her medicare guidelines.Further, the patient complained of back spasms (latency: unknown).On 16-aug-2018, patient reported for follow up on her surgery and stated that she felt sick if she did not take the antibiotics.On (b)(6) 2018, patient reported with the complaint of shoulder pain (latency: unknown) and back pain (latency: unknown).As a corrective for the same, patient was administered a steroid injection.Her right shoulder site was prepped with ethoh/ethy chlorice 1cc per 80 cc depomedrol and 1 cc each of marcaine/ 1% lidocaine was injected using a 27 gauge needle.The patient tolerated the procedure well and was given follow up care instructions.On an unknown date, after unknown latency, patient experienced change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness, muscle weakness, baker's cyst in left knee.It was reported that after the injection, patient was hardly able to walk, had redness, swelling, streaking, limited activities.On the unknown date, patient experienced opioid-induced constipation which got controlled by miralax.Corrective treatment: ciprofloxacin, corticosteroid injection (cortisone), amoxicillin and cephalexine, bilateral knee arthroscopy and debridement for gram neg infection/e coli infection in bones of her knee; use cane and brace for even walking is a chore right now/ hardly able to walk; meloxicam (mobic) and nabumetone (relafen) for medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness; bacterim and doxycycline gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; miralax for constipation, not reported for rest events outcome: not recovered for pain in her right leg from her toes to her hip and experienced pain/pain behind her knees now; unknown for rest events.Seriousness criterion: required intervention and medically significant for gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; disability for even walking is a chore right now/ hardly able to walk, gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis.A product technical complaint (ptc) was initiated 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.Follow up information was received on 03-jan-2018.No new information received.Additional information was received on 22-feb-2018.Investigation summary was added.Text was amended accordingly.Additional information received on 06-sep-2018 from healthcare professional.Case was upgraded to serious and seriousness criterion of intervention required and medically significant added for event gram neg infection/e coli infection in bones of her knee and the case became medically confirmed.Past medical history of hypothyroidism, hypercholesterolemia, biopsy breast, vascular surgery, thyroidectomy, mammogram, cholecystectomy, hysterectomy, ovarian mass, hypertension, type 1 diabetes mellitus, type 2 diabetes mellitus, non-tobacco user and abstains from alcohol.The patient's family history included breast cancer.Concomitant medications added including anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); and zolpidem (zolpidem).Suspect product lot number added.Events of gram neg infection/e coli infection in bones of her knee, eustachian tube dysfunction, anxiety, weight gain, muscle spasm, allergic reaction to something in surgery, shoulder pain, back pain added.Events of swelling, experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee, hot, couldn't put weight on her knees and redness made symptoms of gram neg infection/e coli infection in bones of her knee.Clinical course updated.Text amended accordingly.Additional information received on 11-sep-2018 from physician.Verbatim of even walking is a chore right now was updated to even walking is a chore right now/ hardly able to walk.Event of change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, low grade fever, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness and muscle weakness was added with details.Medical history updated.Additional information received on 14-sep-2018 from healthcare professional.Event of joint lock and small red spots added.Event verbatim updated for experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee to experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee/significant pain and corrective treatment of corticosteroid injection added.Seriousness criterion of disability added for gram neg infection/e coli infection in bones of her knee.Event verbatim updated for low grade fever to low grade fever/fever of around 100 and onset date added.Clinical course updated.Text amended accordingly.Additional information was received on 31-dec-2018 from the healthcare professional.Events of constipation, baker's cyst, bilateral medial meniscus tears were added.Verbatim for gram neg infection/e coli infection in bones of her knee/knee infection updated to gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis.Concomitant medications were updated by adding gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clonazepam (klonopin), atorvastatin calcium (lipitor), metformin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl) and liraglutide (victoza).Past medical treatment was updated by adding baclofen, celebrex, cymbalta, duragesic [fentanyl], flexeril [cefixime], kadian, lidoderm, lodine, lortab [hydrocodone bitartrate;paracetamol], lyrica, motrin, naprosyn [naproxen sodium], neurontin, soma, skelaxine, ultracet, ultram [tramadol hydrochloride], vicodin, norco and zanaflex.Past medical history was updated.Clinical course was updated.Text amended accordingly.Additional information received on 22-jan-2019 form lawyer.Classification of the case was updated.Medical history and concomitant medication was added.Clinical course was updated.Text amended accordingly.

Event Description

Device malfunction [device malfunction] gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis [osteomyelitis] ([weight bearing difficulty], [injection site joint redness], [myalgia], [chills], [knee pain], [swelling of knees], [joint stiffness], [joint warmth], [condition aggravated], [inflammation], [sickness], [escherichia coli infection]) even walking is a chore right now/ hardly able to walk [difficulty in walking] couldn't get out of bed [mobility decreased] pain in her right leg from her toes to her hip [pain in leg] knees are grinding now [unspecified disorder of knee joint] can't stand long at all [difficulty in standing] couldn't even cook for christmas [activities of daily living impaired] flu symptoms [flu symptoms] nauseated [nauseated] weight gain [weight gain] anxiety [anxiety] ([difficulty sleeping], [panic attacks]) allergic reaction to something from surgery [surgical site reaction] back spasms [muscle spasm] back pain [back pain] shoulder pain [shoulder pain] eustachian tube dysfunction [eustachian tube dysfunction] change in vision [abnormal vision] chest pain [chest pain] palpitations [palpitations] shortness of breath [shortness of breath] diarrhea [diarrhea] difficulty urinating [urine incontinence] muscle weakness [muscle weakness] streaking [administration site streaking] low grade fever [fever] medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint crepitation] locking [joint lock] small red spots [spot pigmented] constipation [constipation] bilateral medial meniscus tears [meniscus tear] baker's cyst [baker's cyst] medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint tenderness] case narrative: based on information received on 06-sep-2018 from healthcare professional, this case initially processed as non-serious was upgraded to serious as seriousness criterion of medically significant was added.Further, this case became medically confirmed.This unsolicited legal case from united states was received on 26-dec-2017 from patient.This case involves a 63 years old female patient who experienced gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis, couldn't get out of bed, pain in her right leg from her toes to her hip, knees are grinding now, can't stand long at all, even walking is a chore right now/ hardly able to walk, couldn't even cook for christmas, flu symptoms, nauseated, weight gain, anxiety, allergic reaction to something from surgery, back spasms, back pain, eustachian tube dysfunction, shoulder pain, change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating and muscle weakness, low grade fever/fever of around 100, small red spots, medial and lateral joint line tenderness, patellofemoral crepitus, locking and compression tenderness (latency: unknown), constipation, bilateral medial meniscus tears, baker's cyst in left knee while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added.The patient's past medical history included rheumatoid arthritis, hypothyroidism on (b)(6) 2017 , hypercholesterolemia on (b)(6) 2017 , biopsy breast in 2013, vascular operation on (b)(6) 2017 , thyroidectomy, mammogram on (b)(6) 2016 with another one in (b)(6) 2017 cholecystectomy in (b)(6) 1996 hysterectomy in (b)(6) 2017 ovarian mass, fibromyalgia, autoimmune disorder, osteoporosis, liver disorder, overweight, osteopenia, menopause, arthritis, thyroid disorder, cosmetic surgery in (b)(6) 1980 surgery with thyroid removal in (b)(6)2001, hernia repair in (b)(6)2005, foot surgery heel in (b)(6)2005, haemorrhoid operation in (b)(6)1980, cholecystectomy in (b)(6)1998, caesarean section in (b)(6)1980, caesarean section in (b)(6)1985 and diabetes mellitus type 2, fall in 2007, breast conserving surgery and invasive ductal breast carcinoma.Concurrent conditions included chronic neck pain, low back pain, generalized myofascial and joint pain, chronic reflux esophagitis, obesity, numbness in hands and weakness.The patient's family history included breast cancer on (b)(6)2014.Patient's father experienced cataract and essential hypertension.Her mother had ra, arthritis, breast cancer and essential hypertension.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing hypertension, type 1 diabetes mellitus on (b)(6)2016, type 2 diabetes mellitus on (b)(6)2014, non-tobacco user and abstains from alcohol.Patient denied any allergies to avian proteins, feathers, or egg products.Concomitant medications included methotrexate (methotrexate) for rheumatoid arthritis; anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); zolpidem tartrate (ambien); gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clonazepam (klonopin), atorvastatin calcium (lipitor), metformin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl), morphine sulfate, glucosamine chondroitin, zolpidem, folic acid and liraglutide (victoza) on (b)(6)2017, the patient-initiated treatment with intra-articular hylan g-f 20, sodium hyaluronate injection at a dose of 6 ml once (batch/lot number 7rsl021, expiration: may-2020) for osteoarthritis in both her knees.Under sterile condition and alcohol prep, 6ml of hylan g-f 20, sodium hyaluronate was injected into each knee via inferolateral working portal site.The patient tolerated the procedure well and was given post injection instructions for icing, anti inflammatories and told to follow up in four weeks.Patient stated that right from the beginning she experienced adverse reactions, so she was not asked if she engaged in activities such as jogging or tennis soon after the injection.On an unknown date in 2017, after few days of receiving injection, patient was upset, and she stated that she experienced pain and swelling and "hot".Patient stated that during the first couple of days she experienced redness and swelling.On an unknown date in 2017, latency unknown, patient could not get out of bed and could not put weight on her knees.Patient stated that she was experiencing pain in her right leg from her toes to her hip and that she was experiencing pain behind her knees now.Patient states that she has ra (rheumatoid arthritis) so she was on pain medication, but the pain has been worse since she received the synvisc-one injections.Patient stated that she was using a pain cream as well and was wondering why after a week it was not better.Patient states that this was the fourth time she received the synvisc-one and she would receive it every 6 months.Patient stated that after 5 months she would be in pain, but she would have to wait another month before she could get it again since she has medicare.Patient stated that this did not happen the other three times she had the synvisc-one and it was bad.Patient stated that she could not even cook for christmas because she cannot stand long at all.Patient stated that even walking was a chore right now.Patient was also experiencing flu symptoms and was nauseated and sick.Patient stated that she would go to urgent care today.Patient stated that she did not want knee replacements which was why she was receiving the synvisc-one.Patient stated that the pain was unreal, and she cannot even go to the bathroom because her knees were grinding now.Patient stated that prior to this she was in good health and her pain was tolerable.On (b)(6)2018, patient reported to the clinic and stated that she noticed some improvement after being put on cephalexin but still walks with moderate to severely antalgic gait and has lateral joint line tenderness and compression tenderness which she previously did not have.On (b)(6)2018, patient reported to the clinic with the complaint of a gram negative infection (latency: unknown) and complained of chills, myalgias and bilateral knee pain.It was reported that synvisc one shot was due in may.On (b)(6)2018, patient reported for follow up and reported that she still had significant pain and reported that she has a reaction every time she stops taking cipro.The patient was given bilateral corticosteroid injections in each knee for the same.Post injection instructions for icing and anti-inflammatories were prescribed.The patient further stated that she was in severe pain and feels debilitated by her condition.On (b)(6)2018, patient again reported for a follow up for her infection and complained of anxiety (latency: unknown) and stated she had panic attacks and restless sleep due to the same.Further, the patient also presented with eustachian tube dysfunction and requested for the need of another prescription of antibiotics prescribed to her for the infection.On (b)(6)2018, the patient underwent bilateral knee arthroscopies with debridement for her knee infection.She had "growths" on both knees and hence undergone arthroscopic surgery.The patient was brought to the operative room and was administered anesthesia and pre-operative antibiotics.Both the knees of the patient were prepped in sterile fashion.Two standard portal incisions were made with the scapel, inferolateral for the inflow.The knee showed grade 3 changes of patellofemoral joint with full thickness cartilage defects along trochlear groove.The medial joint had bony eburnation and meniscus tear.The meniscus tear was removed.The biters and grabbers were used to ligamnetum mucosum and other tissues.The knee was re-evaluated after thorough washing out.Each of the two incisions were closed with 3-0 nylon sutures.The knees were cleaned, and antibiotics were given.The patient was sent to recovery room in stable condition.The patient tolerated the procedure well.Post operatively nerve block procedure was performed bilaterally for pain control.The patient tolerated the procedure well.On (b)(6)2018, the adequate culture was sample was collected from left knee.No growth was reported.On (b)(6)2018, patient developed fever of around 100 (latency: 7 months) and had small red spots (latency: 7 months).On (b)(6)2018, patient reported to the clinic for follow up on her surgery and chronic problems and was evaluated extensively for her hypothyroidism, hypercholesterolemia and diabetes.The patient also reported having back pain (latency: unknown) and weight gain (latency: unknown) as a result of stopping her phentermine therapy.On (b)(6)2018, patient reported that she is experiencing locking, swelling, weakness and tenderness.She further reported that she is using a cane now and is able to get around better.On (b)(6)2018, patient reported to the clinic with the complaint of infection in the bones of her knees (latency: unknown) and that her culture had returned with e coli sensitive to doxy and bactrim.On (b)(6)2018, the patient reported having allergic reaction to somethings from surgery (latency: unknown) and requested for an ear checkup and discuss regarding her medicare guidelines.Further, the patient complained of back spasms (latency: unknown).On (b)(6)2018, patient reported for follow up on her surgery and stated that she felt sick if she did not take the antibiotics.On (b)(6)2018, patient reported with the complaint of shoulder pain (latency: unknown) and back pain (latency: unknown).As a corrective for the same, patient was administered a steroid injection.Her right shoulder site was prepped with ethoh/ethy chlorice 1cc per 80 cc depomedrol and 1 cc each of marcaine/ 1% lidocaine was injected using a 27 gauge needle.The patient tolerated the procedure well and was given follow up care instructions.On an unknown date, after unknown latency, patient experienced change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness, muscle weakness, baker's cyst in left knee.It was reported that after the injection, patient was hardly able to walk, had redness, swelling, streaking, limited activities.On the unknown date, patient experienced opioid-induced constipation which got controlled by miralax.Corrective treatment: ciprofloxacin, corticosteroid injection (cortisone), amoxicillin and cephalexine, bilateral knee arthroscopy and debridement for gram neg infection/e coli infection in bones of her knee; use cane and brace for even walking is a chore right now/ hardly able to walk; meloxicam (mobic) and nabumetone (relafen) for medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness; bacterim and doxycycline gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; miralax for constipation, not reported for rest events outcome: not recovered for pain in her right leg from her toes to her hip and experienced pain/pain behind her knees now; unknown for rest events seriousness criterion: required intervention and medically significant for gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; disability for even walking is a chore right now/ hardly able to walk, gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis a product technical complaint (ptc) was initiated 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 (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.Follow up information was received on 03-jan-2018.No new information received.Additional information was received on 22-feb-2018.Investigation summary was added.Text was amended accordingly.Additional information received on 06-sep-2018 from healthcare professional.Case was upgraded to serious and seriousness criterion of intervention required and medically significant added for event gram neg infection/e coli infection in bones of her knee and the case became medically confirmed.Past medical history of hypothyroidism, hypercholesterolemia, biopsy breast, vascular surgery, thyroidectomy, mammogram, cholecystectomy, hysterectomy, ovarian mass, hypertension, type 1 diabetes mellitus, type 2 diabetes mellitus, non-tobacco user and abstains from alcohol.The patient's family history included breast cancer.Concomitant medications added including anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); and zolpidem (zolpidem).Suspect product lot number added.Events of gram neg infection/e coli infection in bones of her knee, eustachian tube dysfunction, anxiety, weight gain, muscle spasm, allergic reaction to something in surgery, shoulder pain, back pain added.Events of swelling, experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee, hot, couldn't put weight on her knees and redness made symptoms of gram neg infection/e coli infection in bones of her knee.Clinical course updated.Text amended accordingly.Additional information received on 11-sep-2018 from physician.Verbatim of even walking is a chore right now was updated to even walking is a chore right now/ hardly able to walk.Event of change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, low grade fever, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness and muscle weakness was added with details.Medical history updated.Additional information received on 14-sep-2018 from healthcare professional.Event of joint lock and small red spots added.Event verbatim updated for experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee to experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee/significant pain and corrective treatment of corticosteroid injection added.Seriousness criterion of disability added for gram neg infection/e coli infection in bones of her knee.Event verbatim updated for low grade fever to low grade fever/fever of around 100 and onset date added.Clinical course updated.Text amended accordingly.Additional information was received on 31-dec-2018 from the healthcare professional.Events of constipation, baker's cyst, bilateral medial meniscus tears were added.Verbatim for gram neg infection/e coli infection in bones of her knee/knee infection updated to gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis.Concomitant medications were updated by adding gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clonazepam (klonopin), atorvastatin calcium (lipitor), metformin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl) and liraglutide (victoza).Past medical treatment was updated by adding baclofen, celebrex, cymbalta, duragesic [fentanyl], flexeril [cefixime], kadian, lidoderm, lodine, lortab [hydrocodone bitartrate;paracetamol], lyrica, motrin, naprosyn [naproxen sodium], neurontin, soma, skelaxine, ultracet, ultram [tramadol hydrochloride], vicodin, norco and zanaflex.Past medical history was updated.Clinical course was updated.Text amended accordingly.Additional information received on 22-jan-2019 form lawyer.Classification of the case was updated.Medical history and concomitant medication added.Clinical course was updated.Text amended accordingly additional information received on28-feb-2019 from healthcare professional.Details pertaining to suspect regimen added.Clinical course updated.Text amended accordingly.

Event Description

Device malfunction [device malfunction] gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis [osteomyelitis] ([inflammation], [chills], [myalgia], [swelling of knees], [knee pain], [joint stiffness], [joint warmth], [weight bearing difficulty], [condition aggravated], [injection site joint redness], [sickness], [escherichia coli infection]) even walking is a chore right now/ hardly able to walk [difficulty in walking] couldn't get out of bed [mobility decreased] pain in her right leg from her toes to her hip [pain in leg] knees are grinding now [unspecified disorder of knee joint] can't stand long at all [difficulty in standing] couldn't even cook for christmas [activities of daily living impaired] flu symptoms [flu symptoms] nauseated [nauseated] weight gain [weight gain] anxiety [anxiety] ([difficulty sleeping], [panic attacks]) allergic reaction to something from surgery [surgical site reaction] back spasms [muscle spasm] back pain [back pain] shoulder pain [shoulder pain] eustachian tube dysfunction [eustachian tube dysfunction] change in vision [abnormal vision] chest pain [chest pain] palpitations [palpitations] shortness of breath [shortness of breath] diarrhea [diarrhea] difficulty urinating [urine incontinence] muscle weakness [muscle weakness] streaking [administration site streaking] low grade fever [fever] medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint tenderness] medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint crepitation] locking [joint lock] small red spots [spot pigmented] constipation [constipation] bilateral medial meniscus tears [meniscus tear] baker's cyst [baker's cyst].Case narrative: based on information received on 06-sep-2018 from healthcare professional, this case initially processed as non-serious was upgraded to serious as seriousness criterion of medically significant was added.Further, this case became medically confirmed.This unsolicited case from united states was received on 26-dec-2017 from patient.This case involves a 63 years old female patient who experienced gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis, couldn't get out of bed, pain in her right leg from her toes to her hip, knees are grinding now, can't stand long at all, even walking is a chore right now/ hardly able to walk, couldn't even cook for christmas, flu symptoms, nauseated, weight gain, anxiety, allergic reaction to something from surgery, back spasms, back pain, eustachian tube dysfunction, shoulder pain, change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating and muscle weakness, low grade fever/fever of around 100, small red spots, medial and lateral joint line tenderness, patellofemoral crepitus, locking and compression tenderness (latency: unknown), constipation, bilateral medial meniscus tears, baker's cyst in left knee while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added.The patient's past medical history included rheumatoid arthritis, hypothyroidism on (b)(6) 2017, hypercholesterolemia on (b)(6) 2017, biopsy breast in 2013, vascular operation on (b)(6) -2017, thyroidectomy, mammogram on (b)(6) 2016 with another one in (b)(6) 2017, cholecystectomy in (b)(6) 1996, hysterectomy in jun-2017, ovarian mass, fibromyalgia, autoimmune disorder, osteoporosis, overweight, osteopenia, menopause, arthritis, thyroid disorder, cosmetic surgery in (b)(6) 1980, surgery with thyroid removal in jun-2001, hernia repair in (b)(6) 2005, foot surgery heel in (b)(6) 2005, haemorrhoid operation in jun-1980, cholecystectomy in (b)(6) 1998, caesarean section in (b)(6) 1980, caesarean section in (b)(6) 1985 and diabetes mellitus type 2, fall in 2007, breast conserving surgery and invasive ductal breast carcinoma.Concurrent conditions included chronic neck pain, low back pain, generalized myofascial and joint pain, chronic reflux esophagitis, obesity, numbness in hands and weakness.The patient's family history included breast cancer on (b)(6) 2014.Patient's father experienced cataract and essential hypertension.Her mother had ra, arthritis, breast cancer and essential hypertension.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing hypertension, type 1 diabetes mellitus on (b)(6) 2016, type 2 diabetes mellitus on (b)(6) 2014, non-tobacco user and abstains from alcohol.Patient denied any allergies to avian proteins, feathers, or egg products.Concomitant medications included methotrexate (methotrexate) for rheumatoid arthritis; anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); zolpidem tartrate (ambien); gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clonazepam (klonopin), atorvastatin calcium (lipitor), metformin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl) and liraglutide (victoza) on (b)(6) 2017, the patient-initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number 7rsl021) for osteoarthritis in both her knees.Patient stated that right from the beginning she experienced adverse reactions, so she was not asked if she engaged in activities such as jogging or tennis soon after the injection.On an unknown date in 2017, after few days of receiving injection, patient was upset, and she stated that she experienced pain and swelling and "hot".Patient stated that during the first couple of days she experienced redness and swelling.On an unknown date in 2017, latency unknown, patient could not get out of bed and could not put weight on her knees.Patient stated that she was experiencing pain in her right leg from her toes to her hip and that she was experiencing pain behind her knees now.Patient states that she has ra (rheumatoid arthritis) so she was on pain medication, but the pain has been worse since she received the synvisc-one injections.Patient stated that she was using a pain cream as well and was wondering why after a week it was not better.Patient states that this was the fourth time she received the synvisc-one and she would receive it every 6 months.Patient stated that after 5 months she would be in pain, but she would have to wait another month before she could get it again since she has medicare.Patient stated that this did not happen the other three times she had the synvisc-one and it was bad.Patient stated that she could not even cook for christmas because she cannot stand long at all.Patient stated that even walking was a chore right now.Patient was also experiencing flu symptoms and was nauseated and sick.Patient stated that she would go to urgent care today.Patient stated that she did not want knee replacements which was why she was receiving the synvisc-one.Patient stated that the pain was unreal, and she cannot even go to the bathroom because her knees were grinding now.Patient stated that prior to this she was in good health and her pain was tolerable.On (b)(6) 2018, patient reported to the clinic and stated that she noticed some improvement after being put on cephalexin but still walks with moderate to severely antalgic gait and has lateral joint line tenderness and compression tenderness which she previously did not have.On (b)(6) 2018, patient reported to the clinic with the complaint of a gram negative infection (latency: unknown) and complained of chills, myalgias and bilateral knee pain.It was reported that synvisc one shot was due in may.On (b)(6) 2018, patient reported for follow up and reported that she still had significant pain and reported that she has a reaction every time she stops taking cipro.The patient was given bilateral corticosteroid injections in each knee for the same.Post injection instructions for icing and anti-inflammatories were prescribed.The patient further stated that she was in severe pain and feels debilitated by her condition.On(b)(6) 2018, patient again reported for a follow up for her infection and complained of anxiety (latency: unknown) and stated she had panic attacks and restless sleep due to the same.Further, the patient also presented with eustachian tube dysfunction and requested for the need of another prescription of antibiotics prescribed to her for the infection.On (b)(6) 2018, the patient underwent bilateral knee arthroscopies with debridement for her knee infection.She had "growths" on both knees and hence undergone arthroscopic surgery.The patient was brought to the operative room and was administered anesthesia and pre-operative antibiotics.Both the knees of the patient were prepped in sterile fashion.Two standard portal incisions were made with the scapel, inferolateral for the inflow.The knee showed grade 3 changes of patellofemoral joint with full thickness cartilage defects along trochlear groove.The medial joint had bony eburnation and meniscus tear.The meniscus tear was removed.The biters and grabbers were used to ligamnetum mucosum and other tissues.The knee was re-evaluated after thorough washing out.Each of the two incisions were closed with 3-0 nylon sutures.The knees were cleaned, and antibiotics were given.The patient was sent to recovery room in stable condition.The patient tolerated the procedure well.On (b)(6) 2018, patient developed fever of around 100 (latency: 7 months) and had small red spots (latency: 7 months).On (b)(6) 2018, patient reported to the clinic for follow up on her surgery and chronic problems and was evaluated extensively for her hypothyroidism, hypercholesterolemia and diabetes.The patient also reported having back pain (latency: unknown) and weight gain (latency: unknown) as a result of stopping her phentermine therapy.On (b)(6) 2018, patient reported that she is experiencing locking, swelling, weakness and tenderness.She further reported that she is using a cane now and is able to get around better.On (b)(6) 2018, patient reported to the clinic with the complaint of infection in the bones of her knees (latency: unknown) and that her culture had returned with e coli sensitive to doxy and bactrim.On (b)(6) 2018, the patient reported having allergic reaction to somethings from surgery (latency: unknown) and requested for an ear checkup and discuss regarding her medicare guidelines.Further, the patient complained of back spasms (latency: unknown).On (b)(6) 2018, patient reported for follow up on her surgery and stated that she felt sick if she did not take the antibiotics.On (b)(6) 2018, patient reported with the complaint of shoulder pain (latency: unknown) and back pain (latency: unknown).As a corrective for the same, patient was administered a steroid injection.Her right shoulder site was prepped with ethoh/ethy chlorice 1cc per 80 cc depomedrol and 1 cc each of marcaine/ 1% lidocaine was injected using a 27 gauge needle.The patient tolerated the procedure well and was given follow up care instructions.On an unknown date, after unknown latency, patient experienced change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness, muscle weakness, baker's cyst in left knee.It was reported that after the injection, patient was hardly able to walk, had redness, swelling, streaking, limited activities.On the unknown date, patient experienced opioid-induced constipation which got controlled by miralax.Corrective treatment: ciprofloxacin, corticosteroid injection (cortisone), amoxicillin and cephalexine, bilateral knee arthroscopy and debridement for gram neg infection/e coli infection in bones of her knee; use cane and brace for even walking is a chore right now/ hardly able to walk; meloxicam (mobic) and nabumetone (relafen) for medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness; bacterim and doxycycline gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; miralax for constipation, not reported for rest events outcome: not recovered for pain in her right leg from her toes to her hip and experienced pain/pain behind her knees now; unknown for rest events seriousness criterion: required intervention and medically significant for gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; disability for even walking is a chore right now/ hardly able to walk, gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis 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.Follow up information was received on 03-jan-2018.No new information received.Additional information was received on 22-feb-2018.Investigation summary was added.Text was amended accordingly.Additional information received on 06-sep-2018 from healthcare professional.Case was upgraded to serious and seriousness criterion of intervention required and medically significant added for event gram neg infection/e coli infection in bones of her knee and the case became medically confirmed.Past medical history of hypothyroidism, hypercholesterolemia, biopsy breast, vascular surgery, thyroidectomy, mammogram, cholecystectomy, hysterectomy, ovarian mass, hypertension, type 1 diabetes mellitus, type 2 diabetes mellitus, non-tobacco user and abstains from alcohol.The patient's family history included breast cancer.Concomitant medications added including anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); and zolpidem (zolpidem).Suspect product lot number added.Events of gram neg infection/e coli infection in bones of her knee, eustachian tube dysfunction, anxiety, weight gain, muscle spasm, allergic reaction to something in surgery, shoulder pain, back pain added.Events of swelling, experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee, hot, couldn't put weight on her knees and redness made symptoms of gram neg infection/e coli infection in bones of her knee.Clinical course updated.Text amended accordingly.Additional information received on 11-sep-2018 from physician.Verbatim of even walking is a chore right now was updated to even walking is a chore right now/ hardly able to walk.Event of change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, low grade fever, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness and muscle weakness was added with details.Medical history updated.Additional information received on 14-sep-2018 from healthcare professional.Event of joint lock and small red spots added.Event verbatim updated for experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee to experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee/significant pain and corrective treatment of corticosteroid injection added.Seriousness criterion of disability added for gram neg infection/e coli infection in bones of her knee.Event verbatim updated for low grade fever to low grade fever/fever of around 100 and onset date added.Clinical course updated.Text amended accordingly.Additional information was received on 31-dec-2018 from the healthcare professional.Events of constipation, baker's cyst, bilateral medial meniscus tears were added.Verbatim for gram neg infection/e coli infection in bones of her knee/knee infection updated to gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis.Concomitant medications were updated by adding gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clonazepam (klonopin), atorvastatin calcium (lipitor), metformin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl) and liraglutide (victoza).Past medical treatment was updated by adding baclofen, celebrex, cymbalta, duragesic [fentanyl], flexeril [cefixime], kadian, lidoderm, lodine, lortab [hydrocodone bitartrate;paracetamol], lyrica, motrin, naprosyn [naproxen sodium], neurontin, soma, skelaxine, ultracet, ultram [tramadol hydrochloride], vicodin, norco and zanaflex.Past medical history was updated.Clinical course was updated.Text amended accordingly.

Event Description

Device malfunction [device malfunction] arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection [joint infection] ([cellulitis knee]) gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis [osteomyelitis] ([weight bearing difficulty], [injection site joint redness], [myalgia], [chills], [knee pain], [swelling of r knee], [joint stiffness], [joint warmth], [condition aggravated], [joint inflammation], [sickness], [escherichia coli infection]) even walking is a chore right now/ hardly able to walk [difficulty in walking] couldn't get out of bed [mobility decreased] pain in her right leg from her toes to her hip [pain in leg] knees are grinding now/ arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection [unspecified disorder of knee joint] can't stand long at all [difficulty in standing] couldn't even cook for christmas [activities of daily living impaired] flu symptoms [flu symptoms] nauseated [nauseated] weight gain [weight gain] anxiety.[anxiety] ([panic attacks], [difficulty sleeping]) allergic reaction to something from surgery [surgical site reaction] back spasms [muscle spasm] back pain [back pain] shoulder pain [shoulder pain] eustachian tube dysfunction [eustachian tube dysfunction] change in vision [abnormal vision] chest pain [chest pain] palpitations [palpitations] shortness of breath [shortness of breath] diarrhea [diarrhea] difficulty urinating [urine incontinence] muscle weakness [muscle weakness] streaking [administration site streaking] low grade fever [fever] medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint crepitation] locking [joint lock] small red spots [spot pigmented] constipation [constipation] bilateral medial meniscus tears [meniscus tear] baker's cyst [baker's cyst] erythema over left posterior knee [erythema] fall [fall] dizzy [dizzy] sick [sickness] medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint tenderness] ([arthralgia aggravated]) surgery [surgery] case narrative: based on information received on 06-sep-2018 from healthcare professional, this case initially processed as non-serious was upgraded to serious as seriousness criterion of medically significant was added.Further, this case became medically confirmed.This unsolicited legal case from united states was received on 26-dec-2017 from patient.This case involves a 63 years old female patient who experienced gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis, couldn't get out of bed, pain in her right leg from her toes to her hip, knees are grinding now/ arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection, can't stand long at all, even walking is a chore right now/ hardly able to walk, couldn't even cook for christmas, flu symptoms, nauseated, weight gain, anxiety, allergic reaction to something from surgery, back spasms, back pain, eustachian tube dysfunction, shoulder pain, change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating and muscle weakness, low grade fever/fever of around 100, small red spots, medial and lateral joint line tenderness, patellofemoral crepitus, locking and compression tenderness (latency: unknown), constipation, bilateral medial meniscus tears, baker's cyst in left knee , arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection, erythema over left posterior knee, fall, dizzy, sick and surgery while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added.The patient's past medical history included rheumatoid arthritis, hypothyroidism on \ (b)(6) 2017, hypercholesterolemia on (b)(6) 2017, biopsy breast in 2013, vascular operation on (b)(6) -2017, thyroidectomy, mammogram on (b)(6) 2016 with another one in (b)(6) 2017, cholecystectomy in (b)(6) 1996, hysterectomy in (b)(6) 2017, ovarian mass, fibromyalgia, autoimmune disorder, osteoporosis, liver disorder, overweight, osteopenia, menopause, arthritis, thyroid disorder, cosmetic surgery in (b)(6) 1980, surgery with thyroid removal in (b)(6) 2001, hernia repair in (b)(6) 2005, foot surgery heel in (b)(6) 2005, haemorrhoid operation in (b)(6) 1980, cholecystectomy in (b)(6) 1998, caesarean section in (b)(6) 1980, caesarean section in (b)(6) 1985 and diabetes mellitus type 2, fall in 2007, breast conserving surgery and invasive ductal breast carcinoma.He also had allergy of penicillin.Concurrent conditions included chronic neck pain, low back pain, generalized myofascial and joint pain, chronic reflux esophagitis, obesity, numbness in hands, hyperlipidemia and weakness.The patient's family history included breast cancer on (b)(6) 2014.Patient's father experienced cataract and essential hypertension.Her mother had ra, arthritis, breast cancer and essential hypertension.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing hypertension, type 1 diabetes mellitus on (b)(6) 2016, type 2 diabetes mellitus on (b)(6) 2014, non-tobacco user and abstains from alcohol.Patient denied any allergies to avian proteins, feathers, or egg products.His family had medical history of hypertension.Concomitant medications included methotrexate (methotrexate) for rheumatoid arthritis; anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); zolpidem tartrate (ambien); gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clotrimazole-betamethasone external cream, clonazepam (klonopin), atorvastatin calcium (lipitor), methin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl), morphine sulfate, glucosamine chondroitin, zolpidem, folic acid, liraglutide (victoza), fluconazole (diflucan), biotin, acetylsalicylic acid (aspirin) and omeprazole.On (b)(6) 2017, the patient-initiated treatment with intra-articular hylan g-f 20, sodium hyaluronate injection at a dose of 6 ml once (batch/lot number 7rsl021, expiration: may-2020) for osteoarthritis in both her knees.Under sterile condition and alcohol prep, 6ml of hylan g-f 20, sodium hyaluronate was injected into each knee via inferolateral working portal site.The patient tolerated the procedure well and was given post injection instructions for icing, anti inflammatories and told to follow up in four weeks.Patient stated that right from the beginning she experienced adverse reactions, so she was not asked if she engaged in activities such as jogging or tennis soon after the injection.On an unknown date in 2017, after few days of receiving injection, patient was upset, and she stated that she experienced pain and swelling and "hot".Patient stated that during the first couple of days she experienced redness and swelling.On an unknown date in 2017, latency unknown, patient could not get out of bed and could not put weight on her knees.Patient stated that she was experiencing pain in her right leg from her toes to her hip and that she was experiencing pain behind her knees now.Patient states that she has ra (rheumatoid arthritis) so she was on pain medication, but the pain has been worse since she received the synvisc-one injections.Patient stated that she was using a pain cream as well and was wondering why after a week it was not better.Patient states that this was the fourth time she received the synvisc-one and she would receive it every 6 months.Patient stated that after 5 months she would be in pain, but she would have to wait another month before she could get it again since she has medicare.Patient stated that this did not happen the other three times she had the synvisc-one and it was bad.Patient stated that she could not even cook for christmas because she cannot stand long at all.Patient stated that even walking was a chore right now.Patient was also experiencing flu symptoms and was nauseated and sick.Patient stated that she would go to urgent care today.Patient stated that she did not want knee replacements which was why she was receiving the synvisc-one.Patient stated that the pain was unreal, and she cannot even go to the bathroom because her knees were grinding now.Patient stated that prior to this she was in good health and her pain was tolerable.On 23-jan-2018, patient reported to the clinic and stated that she noticed some improvement after being put on cephalexin but still walks with moderate to severely antalgic gait and has lateral joint line tenderness and compression tenderness which she previously did not have.On (b)(6) 2018, patient reported to the clinic with the complaint of a gram negative infection (latency: unknown) and complained of chills, myalgias and bilateral knee pain.It was reported that synvisc one shot was due in may.On (b)(6) 2018, patient reported for follow up and reported that she still had significant pain and reported that she has a reaction every time she stops taking cipro.The patient was given bilateral corticosteroid injections in each knee for the same.Post injection instructions for icing and anti-inflammatories were prescribed.The patient further stated that she was in severe pain and feels debilitated by her condition.On (b)(6) 2018, patient again reported for a follow up for her infection and complained of anxiety (latency: unknown) and stated she had panic attacks and restless sleep due to the same.Further, the patient also presented with eustachian tube dysfunction and requested for the need of another prescription of antibiotics prescribed to her for the infection.On (b)(6) 2018, the patient underwent bilateral knee arthroscopies with debridement for her knee infection.She had "growths" on both knees and hence undergone arthroscopic surgery.The patient was brought to the operative room and was administered anesthesia and pre-operative antibiotics.Both the knees of the patient were prepped in sterile fashion.Two standard portal incisions were made with the scapel, inferolateral for the inflow.The knee showed grade 3 changes of patellofemoral joint with full thickness cartilage defects along trochlear groove.The medial joint had bony eburnation and meniscus tear.The meniscus tear was removed.The biters and grabbers were used to ligamnetum mucosum and other tissues.The knee was re-evaluated after thorough washing out.Each of the two incisions were closed with 3-0 nylon sutures.The knees were cleaned, and antibiotics were given.The patient was sent to recovery room in stable condition.The patient tolerated the procedure well.Post operatively nerve block procedure was performed bilaterally for pain control.The patient tolerated the procedure well.On (b)(6) 2018, the adequate culture was sample was collected from left knee.No growth was reported.He had surgery.On (b)(6) 2018, patient had bilateral arthroscopy and it was observed that there were small percentage of e.Coli.On (b)(6) 2018, patient developed fever of around 100 (latency: 7 months) and had small red spots (latency: 7 months).On (b)(6) 2018, patient reported to the clinic for follow up on her surgery and chronic problems and was evaluated extensively for her hypothyroidism, hypercholesterolemia and diabetes.The patient also reported having back pain (latency: unknown) and weight gain (latency: unknown) as a result of stopping her phentermine therapy.On (b)(6) 2018, patient reported that she is experiencing locking, swelling, weakness and tenderness.She further reported that she is using a cane now and is able to get around better.On (b)(6) 2018, patient reported to the clinic with the complaint of infection in the bones of her knees (latency: unknown) and that her culture had returned with e coli sensitive to doxy and bactrim.On (b)(6) 2018, the patient reported having allergic reaction to somethings from surgery (latency: unknown) and requested for an ear checkup and discuss regarding her medicare guidelines.Further, the patient complained of back spasms (latency: unknown).On (b)(6) 2018, patient reported for follow up on her surgery and stated that she felt sick if she did not take the antibiotics.On the same date, during medical evaluation, it was observed that both knees were healed and no infections were observed.On (b)(6) 2018, patient reported with the complaint of shoulder pain (latency: unknown) and back pain (latency: unknown).As a corrective for the same, patient was administered a steroid injection.Her right shoulder site was prepped with ethoh/ethy chlorice 1cc per 80 cc depomedrol and 1 cc each of marcaine/ 1% lidocaine was injected using a 27 gauge needle the patient tolerated the procedure well and was given follow up care instructions.On (b)(6) 2018, the patient was started with augmentinon (b)(6) 2018, during medical evaluation, patient was having oral antibiotics for worsening knee pain/ swelling and erythema and diagnosed with arthropathy of the knee/ patella/ tibia/ fibula associated with bacterial infection.On further evaluation patient was observed with knees showed abnormalities mild knee swelling.On (b)(6) 2018, patient developed posterior erythema which was persistent was evaluated in emergency room for left cellulitis was started on oral ciprofloxacin and doxycycline.Patient was diagnosed with cellulitis of the knee.On (b)(6) 2018, absolute neutrophils were 9266 cell/ul (high), absolute neutrophils count was 3918 cell/ul (high) and white blood cell count was 14.3 thousand/ul (high).On (b)(6) 2019, during the medical evaluation, it was observed with recurrence of erythema over left posterior knee then right knee.On an unknown date, after unknown latency, patient experienced change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness, muscle weakness, baker's cyst in left knee.It was reported that after the injection, patient was hardly able to walk, had redness, swelling, streaking, limited activities.On the unknown date, patient experienced opioid-induced constipation which got controlled by miralax.The events of gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis, arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection were assessed as seriousness criteria of medically significant and intervention required.The event of walking is a chore right now/ hardly able to walk, gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis were assessed as serious with the seriousness criteria of disability.Corrective treatment: ciprofloxacin, corticosteroid injection (cortisone), amoxicillin and cephalexine, bilateral knee arthroscopy and debridement for gram neg infection/e coli infection in bones of her knee; use cane and brace for even walking is a chore right now/ hardly able to walk; meloxicam (mobic) and nabumetone (relafen) for medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness; bacterim and doxycycline gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; miralax for constipation, not reported for rest events outcome: not recovered for pain in her right leg from her toes to her hip and experienced pain/pain behind her knees now, palpitations; unknown for rest events seriousness criterion: medically significant for arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection and device malfunction; required intervention and medically significant for gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; disability for event of walking is a chore right now/ hardly able to walk, gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis a product technical complaint (ptc) was initiated 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.Follow up information was received on 03-jan-2018.No new information received.Additional information was received on 22-feb-2018.Investigation summary was added.Text was amended accordingly.Additional information received on 06-sep-2018 from healthcare professional.Case was upgraded to serious and seriousness criterion of intervention required and medically significant added for event gram neg infection/e coli infection in bones of her knee and the case became medically confirmed.Past medical history of hypothyroidism, hypercholesterolemia, biopsy breast, vascular surgery, thyroidectomy, mammogram, cholecystectomy, hysterectomy, ovarian mass, hypertension, type 1 diabetes mellitus, type 2 diabetes mellitus, non-tobacco user and abstains from alcohol.The patient's family history included breast cancer.Concomitant medications added including anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); and zolpidem (zolpidem).Suspect product lot number added.Events of gram neg infection/e coli infection in bones of her knee, eustachian tube dysfunction, anxiety, weight gain, muscle spasm, allergic reaction to something in surgery, shoulder pain, back pain added.Events of swelling, experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee, hot, couldn't put weight on her knees and redness made symptoms of gram neg infection/e coli infection in bones of her knee.Clinical course updated.Text amended accordingly.Additional information received on 11-sep-2018 from physician.Verbatim of even walking is a chore right now was updated to even walking is a chore right now/ hardly able to walk.Event of change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, low grade fever, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness and muscle weakness was added with details.Medical history updated.Additional information received on 14-sep-2018 from healthcare professional.Event of joint lock and small red spots added.Event verbatim updated for experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee to experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee/significant pain and corrective treatment of corticosteroid injection added.Seriousness criterion of disability added for gram neg infection/e coli infection in bones of her knee.Event verbatim updated for low grade fever to low grade fever/fever of around 100 and onset date added.Clinical course updated.Text amended accordingly.Additional information was received on 31-dec-2018 from the healthcare professional.Events of constipation, baker's cyst, bilateral medial meniscus tears were added.Verbatim for gram neg infection/e coli infection in bones of her knee/knee infection updated to gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis.Concomitant medications were updated by adding gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clonazepam (klonopin), atorvastatin calcium (lipitor), metformin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl) and liraglutide (victoza).Past medical treatment was updated by adding baclofen, celebrex, cymbalta, duragesic [fentanyl], flexeril [cefixime], kadian, lidoderm, lodine, lortab [hydrocodone bitartrate;paracetamol], lyrica, motrin, naprosyn [naproxen sodium], neurontin, soma, skelaxine, ultracet, ultram [tramadol hydrochloride], vicodin, norco and zanaflex.Past medical history was updated.Clinical course was updated.Text amended accordingly.Additional information received on 22-jan-2019 form lawyer.Classification of the case was updated.Medical history and concomitant medication added.Clinical course was updated.Text amended accordingly additional information received on 28-feb-2019 from healthcare professional.Details pertaining to suspect regimen added.Clinical course updated.Text amended accordingly.Additional information was received on 01-jul-2019 from lawyer.Additional events of arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection, erythema over left posterior knee, fall, dizzy and sick was added.Verbatim for knees are grinding now updated to knees are grinding now/ arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection.Start date of suspect product was updated.Concomitant medications were added.Allergy added.Family history of hypertension was added.Clinical course updated, and text amended accordingly.

Event Description

Device malfunction [device malfunction].Arthropathy of the knee/ patella/ tibia/ fibula associated with bacterial infection [joint infection] ([cellulitis knee]).Gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis [osteomyelitis] ([weight bearing difficulty], [injection site joint redness], [myalgia], [chills], [knee pain], [swelling of r knee], [joint stiffness], [joint warmth], [condition aggravated], [joint inflammation], [sickness], [escherichia coli infection]).Even walking is a chore right now/ hardly able to walk/antalgic gait [difficulty in walking].Couldn't get out of bed [mobility decreased].Pain in her right leg from her toes to her hip [pain in leg].Knees are grinding now/ arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection [unspecified disorder of knee joint].Can't stand long at all [difficulty in standing].Couldn't even cook for christmas [activities of daily living impaired].Flu symptoms [flu symptoms].Nauseated [nauseated].Weight gain [weight gain].Anxiety [anxiety] ([panic attacks], [difficulty sleeping]).Allergic reaction to something from surgery [surgical site reaction].Back spasms [muscle spasm].Back pain [back pain].Shoulder pain [shoulder pain].Eustachian tube dysfunction [eustachian tube dysfunction].Change in vision [abnormal vision].Chest pain [chest pain].Palpitations [palpitations].Shortness of breath [shortness of breath].Diarrhea [diarrhea].Difficulty urinating [urine incontinence].Muscle weakness [muscle weakness].Streaking [administration site streaking].Low grade fever [fever].Medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness/peripatellar crepitus [joint crepitation].Locking [joint lock].Small red spots [spot pigmented].Constipation [constipation].Bilateral medial meniscus tears [meniscus tear].Baker's cyst [baker's cyst].Erythema over left posterior knee [erythema].Pain as burning and throbbing [pain burning].Fall [fall].Dizzy [dizzy].Sick [sickness].Medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness [joint tenderness] ([arthralgia aggravated]).Surgery [surgery].Case narrative: based on information received on (b)(6) 2018 from healthcare professional, this case initially processed as non-serious was upgraded to serious as seriousness criterion of medically significant was added.Further, this case became medically confirmed.This unsolicited valid serious legal case from united states was received on 26-dec-2017 from patient.This case involves a 63 years old female patient who experienced gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis, couldn't get out of bed, pain in her right leg from her toes to her hip, knees are grinding now/ arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection, can't stand long at all, even walking is a chore right now/ hardly able to walk/antalgic gait/limp on right and limp on left, couldn't even cook for christmas, flu symptoms, nauseated, weight gain, anxiety, allergic reaction to something from surgery, back spasms, back pain, eustachian tube dysfunction, shoulder pain, change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating and muscle weakness, low grade fever/fever of around 100, small red spots, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness/peripatellar crepitus, locking and compression tenderness (latency: unknown), constipation, bilateral medial meniscus tears, baker's cyst in left knee , arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection, erythema over left posterior knee, fall, dizzy, pain as burning and throbbing (latency: 7 months 24 days), sick and surgery while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added.The patient's past medical history included rheumatoid arthritis, hypothyroidism on (b)(6) 2017, hypercholesterolemia on (b)(6) 2017, biopsy breast in 2013, vascular operation on (b)(6) 2017, thyroidectomy, mammogram on (b)(6) 2016 with another one in (b)(6) 2017, cholecystectomy in 1996, hysterectomy in 2017, ovarian mass, fibromyalgia, fracture repair of the elbow/wrist due to broken bone, autoimmune disorder, osteoporosis, liver disorder/cirrhosis, overweight, osteopenia, menopause, arthritis, thyroid disorder, cosmetic surgery in 1980, surgery with thyroid removal in 2001, hernia repair in 2005, foot surgery heel in 2005, haemorrhoid operation in 1980, cholecystectomy in (b)(6) 1998, caesarean section in 1980, caesarean section in 1985 and diabetes mellitus type 2, fall in 2007, breast conserving surgery and invasive ductal breast carcinoma.He also had allergy of penicillin.Patient got sick and had fatty liver due to duexis.Concurrent conditions included chronic neck pain, low back pain, generalized myofascial and joint pain, chronic reflux esophagitis, obesity, numbness in hands, hyperlipidemia and weakness.The patient's family history included breast cancer on (b)(6) 2014.Patient's father experienced cataract and essential hypertension.Her mother had ra, arthritis, breast cancer and essential hypertension.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing hypertension, type 1 diabetes mellitus on (b)(6) 2016, type 2 diabetes mellitus on (b)(6) 2014, non-tobacco user and abstains from alcohol.Patient denied any allergies to avian proteins, feathers, or egg products.His family had medical history of hypertension.Concomitant medications included methotrexate sodium (methotrexate sodium) for rheumatoid arthritis; anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (prilosec); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); zolpidem tartrate (ambien); gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clotrimazole-betamethasone external cream, clonazepam (klonopin), atorvastatin calcium (lipitor), methin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl), morphine sulfate, glucosamine chondroitin, zolpidem, folic acid, liraglutide (victoza), fluconazole (diflucan), biotin, acetylsalicylic acid (aspirin), potassium chloride, diclofenac sodium [voltaren], furosemide [lasix], baclofen on (b)(6) 2017, the patient-initiated treatment with intra-articular hylan g-f 20, sodium hyaluronate injection at a dose of 6 ml once (batch/lot number 7rsl021, expiration: may-2020) for osteoarthritis in both her knees.Under sterile condition and alcohol prep, 6ml of hylan g-f 20, sodium hyaluronate was injected into each knee via inferolateral working portal site.The patient tolerated the procedure well and was given post injection instructions for icing, anti inflammatories and told to follow up in four weeks.Patient stated that right from the beginning she experienced adverse reactions, so she was not asked if she engaged in activities such as jogging or tennis soon after the injection.On an unknown date in 2017, after few days of receiving injection, patient was upset, and she stated that she experienced pain and swelling and "hot".Patient stated that during the first couple of days she experienced redness and swelling.On an unknown date in 2017, latency unknown, patient could not get out of bed and could not put weight on her knees.Patient stated that she was experiencing pain in her right leg from her toes to her hip and that she was experiencing pain behind her knees now.Patient states that she has ra (rheumatoid arthritis) so she was on pain medication, but the pain has been worse since she received the synvisc-one injections.Patient stated that she was using a pain cream as well and was wondering why after a week it was not better.Patient states that this was the fourth time she received the synvisc-one and she would receive it every 6 months.Patient stated that after 5 months she would be in pain, but she would have to wait another month before she could get it again since she has medicare.Patient stated that this did not happen the other three times she had the synvisc-one and it was bad.Patient stated that she could not even cook for christmas because she cannot stand long at all.Patient stated that even walking was a chore right now.Patient was also experiencing flu symptoms and was nauseated and sick.Patient stated that she would go to urgent care today.Patient stated that she did not want knee replacements which was why she was receiving the synvisc-one.Patient stated that the pain was unreal, and she cannot even go to the bathroom because her knees were grinding now.Patient stated that prior to this she was in good health and her pain was tolerable.On (b)(6) 2018, patient reported to the clinic and stated that she noticed some improvement after being put on cephalexin but still walks with moderate to severely antalgic gait and has lateral joint line tenderness and compression tenderness which she previously did not have.On (b)(6) 2018, patient reported to the clinic with the complaint of a gram negative infection (latency: unknown) and complained of chills, myalgias and bilateral knee pain.It was reported that synvisc one shot was due in may.On (b)(6) 2018, patient reported for follow up and reported that she still had significant pain and reported that she has a reaction every time she stops taking cipro.The patient was given bilateral corticosteroid injections in each knee for the same.Post injection instructions for icing and anti-inflammatories were prescribed.The patient further stated that she was in severe pain and feels debilitated by her condition.On (b)(6) 2018, patient reported for follow up and was instructed to continue with non operative treatments and was not ready for knee arthroplasty for now.The patient further felt that her infection had come up again.On 24-may-2018, patient was recommended bilateral knee scopes for washout and culture.On 25-may-2018, patient again reported for a follow up for her infection and complained of anxiety (latency: unknown) and stated she had panic attacks and restless sleep due to the same.Further, the patient also presented with eustachian tube dysfunction and requested for the need of another prescription of antibiotics prescribed to her for the infection.On (b)(6) 2018, the patient underwent bilateral knee arthroscopies with debridement for her knee infection.She had "growths" on both knees and hence undergone arthroscopic surgery.The patient was brought to the operative room and was administered anesthesia and pre-operative antibiotics.Both the knees of the patient were prepped in sterile fashion.Two standard portal incisions were made with the scapel, inferolateral for the inflow.The knee showed grade 3 changes of patellofemoral joint with full thickness cartilage defects along trochlear groove.The medial joint had bony eburnation and meniscus tear.The meniscus tear was removed.The biters and grabbers were used to ligamnetum mucosum and other tissues.The knee was re-evaluated after thorough washing out.Each of the two incisions were closed with 3-0 nylon sutures.The knees were cleaned, and antibiotics were given.The patient was sent to recovery room in stable condition.The patient tolerated the procedure well.Post operatively nerve block procedure was performed bilaterally for pain control.The patient tolerated the procedure well.On (b)(6) 2018, the adequate culture was sample was collected from left knee.No growth was reported.He had surgery.On (b)(6) 2018, patient had bilateral arthroscopy and it was observed that there were small percentage of e.Coli.Microgen was positive in left knee with e.Coli.On (b)(6) 2018, patient developed fever of around 100 (latency: 7 months) and had small red spots (latency: 7 months).On (b)(6) 2018, patient reported to the clinic for follow up on her surgery and chronic problems and was evaluated extensively for her hypothyroidism, hypercholesterolemia and diabetes.The patient also reported having back pain (latency: unknown) and weight gain (latency: unknown) as a result of stopping her phentermine therapy.On (b)(6) 2018, patient reported that she is experiencing locking, swelling, weakness and tenderness.The patient described pain as burning and throbbing (latency: 7 months 24 days) and rated her pain as 3 on a scale of 10.Her wbc increased to 12.9 and she had been on cipro for the past seven months.She further reported that she is using a cane now and is able to get around better.Patient added that she was doing better and was no longer taking cipro for her knee infection.On (b)(6) 2018, patient reported to the clinic with the complaint of infection in the bones of her knees (latency: unknown) and that her culture had returned with e coli sensitive to doxy and bactrim.On (b)(6) 2018, the patient reported having allergic reaction to somethings from surgery (latency: unknown) and requested for an ear checkup and discuss regarding her medicare guidelines.Further, the patient complained of back spasms (latency: unknown).On 16-aug-2018, patient reported for follow up on her surgery and stated that she felt sick if she did not take the antibiotics.On the same date, during medical evaluation, it was observed that both knees were healed and no infections were observed.On (b)(6) 2018, patient reported with the complaint of shoulder pain (latency: unknown) and back pain (latency: unknown).As a corrective for the same, patient was administered a steroid injection.Her right shoulder site was prepped with ethoh/ethy chlorice 1cc per 80 cc depomedrol and 1 cc each of marcaine/ 1% lidocaine was injected using a 27 gauge needle.The patient tolerated the procedure well and was given follow up care instructions.On (b)(6) 2018, patient tested positive for microorganism in her left knee and negative in right.The same day, 5cc straw colored fluid was withdrawn from the knee and sent for culture.The patient was experiencing tenderness and rated her pain 6 on a scale of 10.The pain continued to be burning and throbbing in nature.Patient still had pain however with walking and activities od daily living.An x-ray of both her knees was done, which revealed medial joint space narrowing with marginal osteophyte formation, periarticular sclerosis and cysts bilaterally.The same day, right knee aspiration was performed, 5cc of fluid was withdrawn from the right knee under sterile conditions.On 25-oct-2018, patient reported for follow up of her left knee problem.She rated her pain 1 on a scale of 10 and described her pain as burning and throbbing and stated that the problem was staying the same.She had antalgic gait on both sides and limp on right and limp on left.The patient was advised to perform strengthening exercises and reduce her weight.The patient needed an articular spacer for her left knee due to her history of infection.On (b)(6) 2018, the patient was started with augmentin.On (b)(6) 2018, during medical evaluation, patient was having oral antibiotics for worsening knee pain/ swelling and erythema and diagnosed with arthropathy of the knee/ patella/ tibia/ fibula associated with bacterial infection.On further evaluation patient was observed with knees showed abnormalities mild knee swelling.On (b)(6) 2018, patient developed posterior erythema which was persistent was evaluated in emergency room for left cellulitis was started on oral ciprofloxacin and doxycycline.Patient was diagnosed with cellulitis of the knee.On (b)(6) 2018, absolute neutrophils were 9266 cell/ul (high), absolute neutrophils count was 3918 cell/ul (high) and white blood cell count was 14.3 thousand/ul (high).On (b)(6) 2019, during the medical evaluation, it was observed with recurrence of erythema over left posterior knee then right knee.On an unknown date, after unknown latency, patient experienced change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness, muscle weakness, baker's cyst in left knee.It was reported that after the injection, patient was hardly able to walk, had redness, swelling, streaking, limited activities.On the unknown date, patient experienced opioid-induced constipation which got controlled by miralax.The events of gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis, arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection were assessed as seriousness criteria of medically significant and intervention required.The event of walking is a chore right now/ hardly able to walk, gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis were assessed as serious with the seriousness criteria of disability.Corrective treatment: ciprofloxacin, corticosteroid injection (cortisone), amoxicillin and cephalexine, bilateral knee arthroscopy and debridement for gram neg infection/e coli infection in bones of her knee; use cane and brace for even walking is a chore right now/ hardly able to walk; meloxicam (mobic) and nabumetone (relafen) for medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness/peripatellar crepitus; bacterim and doxycycline gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; miralax for constipation; doxycycline, bactrim, cipro for arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection; not reported for rest events seriousness criterion: medically significant for arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection and device malfunction; required intervention and medically significant for gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis; disability for event of walking is a chore right now/ hardly able to walk, gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis a product technical complaint (ptc) was initiated 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.Follow up information was received on 03-jan-2018.No new information received.Additional information was received on 22-feb-2018.Investigation summary was added.Text was amended accordingly.Additional information received on 06-sep-2018 from healthcare professional.Case was upgraded to serious and seriousness criterion of intervention required and medically significant added for event gram neg infection/e coli infection in bones of her knee and the case became medically confirmed.Past medical history of hypothyroidism, hypercholesterolemia, biopsy breast, vascular surgery, thyroidectomy, mammogram, cholecystectomy, hysterectomy, ovarian mass, hypertension, type 1 diabetes mellitus, type 2 diabetes mellitus, non-tobacco user and abstains from alcohol.The patient's family history included breast cancer.Concomitant medications added including anastrozole (anastrozole); chlorthalidone (chlorthalidone); clonazepam (clonazepam); losartan (losartan); morphine (morphine); naloxone hydrochloride (narcan); omeprazole (omeprazole); oxycodone (oxycodone); pravastatin (pravastatin); promethazine (promethazine); and zolpidem (zolpidem).Suspect product lot number added.Events of gram neg infection/e coli infection in bones of her knee, eustachian tube dysfunction, anxiety, weight gain, muscle spasm, allergic reaction to something in surgery, shoulder pain, back pain added.Events of swelling, experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee, hot, couldn't put weight on her knees and redness made symptoms of gram neg infection/e coli infection in bones of her knee.Clinical course updated.Text amended accordingly.Additional information received on 11-sep-2018 from physician.Verbatim of even walking is a chore right now was updated to even walking is a chore right now/ hardly able to walk.Event of change in vision, chest pain, palpitations, shortness of breath, diarrhea, difficulty urinating, low grade fever, medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness and muscle weakness was added with details.Medical history updated.Additional information received on 14-sep-2018 from healthcare professional.Event of joint lock and small red spots added.Event verbatim updated for experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee to experienced pain/pain behind her knees now/bilateral knee pain/right knee worse than left knee/significant pain and corrective treatment of corticosteroid injection added.Seriousness criterion of disability added for gram neg infection/e coli infection in bones of her knee.Event verbatim updated for low grade fever to low grade fever/fever of around 100 and onset date added.Clinical course updated.Text amended accordingly.Additional information was received on 31-dec-2018 from the healthcare professional.Events of constipation, baker's cyst, bilateral medial meniscus tears were added.Verbatim for gram neg infection/e coli infection in bones of her knee/knee infection updated to gram neg infection/e coli infection in bones of her knee/knee infection/osteomyelitis.Concomitant medications were updated by adding gabapentin (gabapentin), diclofenac sodium (diclofenac sodium), famotidine, ibuprofen (duexis), levothyroxine sodium (levothyroxine sodium), clonazepam (klonopin), atorvastatin calcium (lipitor), metformin hcl (metformin hcl), metoclopramide hcl (metoclopramide hcl), pramipexole dihydrochloride (mirapex), oxybutynin chloride (oxybutynin chloride), phentermine hcl (phentermine hcl) and liraglutide (victoza).Past medical treatment was updated by adding baclofen, celebrex, cymbalta, duragesic [fentanyl], flexeril [cefixime], kadian, lidoderm, lodine, lortab [hydrocodone bitartrate;paracetamol], lyrica, motrin, naprosyn [naproxen sodium], neurontin, soma, skelaxine, ultracet, ultram [tramadol hydrochloride], vicodin, norco and zanaflex.Past medical history was updated.Clinical course was updated.Text amended accordingly.Additional information received on 22-jan-2019 form lawyer.Classification of the case was updated.Medical history and concomitant medication added.Clinical course was updated.Text amended accordingly additional information received on 28-feb-2019 from healthcare professional.Details pertaining to suspect regimen added.Clinical course updated.Text amended accordingly.Additional information was received on 01-jul-2019 from lawyer.Additional events of arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection, erythema over left posterior knee, fall, dizzy and sick was added.Verbatim for knees are grinding now updated to knees are grinding now/ arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection.Start date of suspect product was updated.Concomitant medications were added.Allergy added.Family history of hypertension was added.Clinical course updated, and text amended accordingly.Additional information received on 28-jun-2019 from lawyer.Surgical history of fracture repair of the elbow/wrist due to broken bone added.Verbatim updated to medial and lateral joint line tenderness, patellofemoral crepitus and compression tenderness/peripatellar crepitus.Corrective treatment added for arthropathy of the knee/ pateela/ tibia/ fibula associated with bacterial infection.Lab test result for wbc added.Events of pain as burning and throbbing added.Verbatim updated from even walking is a chore right now/ hardly able to walk to even walking is a chore right now/ hardly able to walk/antalgic gait/limp on right and limp on left.Concomitant medications added: potassium chloride, diclofenac sodium [voltaren], furosemide [lasix], baclofen.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 8005389
• MDR Text Key: 125108487
• Report Number: 2246315-2018-00617
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/15/2019; 01/31/2019; 03/13/2019; 07/05/2019; 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANASTROZOLE (ANASTROZOLE),; CHLORTHALIDONE (CHLORTHALIDONE),; CLONAZEPAM (CLONAZEPAM),; LOSARTAN (LOSARTAN),; METHOTREXATE (METHOTREXATE),; MORPHINE (MORPHINE),; NARCAN (NALOXONE HYDROCHLORIDE),; OMEPRAZOLE (OMEPRAZOLE),; OXYCODONE (OXYCODONE),; PRAVASTATIN (PRAVASTATIN),; PROMETHAZINE (PROMETHAZINE),; ZOLPIDEM (ZOLPIDEM),
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Weight: 91