| Lot Number 7RSL021 |
| Device Problems
Contamination (1120); Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Pain (1994); Sepsis (2067); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191); Cancer (3262)
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Event Type
Injury
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Event Description
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This unsolicited case from united states was received on 02-feb-2018 from the patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and after few hours patient had swelling, began to experience pain/pain became so excruciating/both knees were in pain, but the right knee hurt more/pain was far beyond anything she could endure/her right knee hurts more when exercising; after unknown latency, the patient could not walk, fluid was drawn off the right knee, leg did not pass the range of mobility test and did not get any benefit from the shots (device ineffective); also, device malfunction was identified for the reported lot number.No concomitant medication or concurrent condition was provided.Patient had received synvisc one on two separate occasions in the past without problem.Medical history included liver disease and diabetes.Patient does not have any artificial joints, heart valves, pacemaker, or defibrillator.Patient denied allergies to avian proteins, birds, eggs, or feathers.On (b)(6) 2017, the patient initiated treatment with single intra-articular synvisc one injection, once at the dose of 6 ml (batch/lot number: 7rsl021; expiry date: not reported) bilaterally for knee osteoarthritis (oa).Following the administration, as patient was traveling the 10-hour ride home, patient began to experience pain after about 3 hours.Patient was using ice, as she had with past injections.The ice was not helping.The pain became more intense and she had swelling.Both knees were in pain, but the right knee hurt more.The pain became so excruciating that patient "had no choice but to go to er.Patient could not walk at that point due to the pain and swelling.At the er, patient had to be put in a wheelchair.They ran tests, ruled out a blood clot and sent her home with a walker.The doctor sent a steroid medication to help the swelling.It took almost 2 weeks at home to get the leg to function normally.Then patient got a call on (b)(6) 2017 about 5 pm from the doctor informing her that the synvisc one patient received was contaminated.It was the understanding that she received recalled product in both knees.The physician asked her to travel back the next day.Patient made the 10-hour trip back.The doctor was concerned that the steroids she had given the might suppress her immune system's ability to fight a possible infection.At the office, fluid was drawn off the right knee only.The leg did not pass the range of mobility tests.Patient and her husband stayed in a hotel for a couple nights.Then patient went home.Patient heard that the preliminary test of the fluid was okay.Then about 2 weeks ago, patient received word that the last culture would be okay.It was "a huge inconvenience and expense for us." patient expressed that she can usually endure pain rather well, but this pain was far beyond anything she could endure.Patient was also frustrated that when the fluid was removed, it also removed the synvisc.Therefore she did not get any benefit from the shot/s.Patient was not currently using a walker.The symptoms were the same as prior to injection-her right knee hurts more when exercising, she used a leg brace and was icing.It was reported that the patient had no relief.It affected her life a lot being immobile for two weeks.Patient was very concerned about potential long-term effects.Corrective treatment: wheelchair and walker for could not walk; steroid for had swelling; ice and leg brace for began to experience pain/pain became so excruciating/both knees were in pain, but the right knee hurt more/pain was far beyond anything she could endure/her right knee hurts more when exercising; not reported for rest outcome: unknown for all an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: disability for device malfunction could not walk; required intervention for had swelling.Pharmacovigilance comment: sanofi company comment dated 2-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced difficulty walking, knee swelling knee pain, knee effusion, joint range of motion decreased and device ineffective.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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Device malfunction [device malfunction].Could not walk [difficulty in walking].Knees getting tighter and tighter/everything feels too tight [joint stiffness].She had swelling/both of her knees are quite swollen [knee swelling].Pseudohypersensitivity response/pseudohypersensitivity reaction to the bilateral synvisc injection given to knees/sensitivity [pseudosepsis].Experience pain/pain became so excruciating /both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising /soreness in knee/ posterior pain [knee pain] ([condition worsened]).Flexing her right foot caused extreme pain in her knee/radiation of pain to dorsum of foot [pain upon movement].Bladder tumor [bladder cancer nos].Fluid was drawn off the right knee/aspirated knee fluid/effusion aspirating 3 cc fluid/right knee effusion [knee effusion] leg did not pass the range of mobility test/lacks about 2 degrees of extension/cannot fully straighten out her knees getting tighter and tighter [joint range of motion decreased].Discomfort [discomfort].Back of her right knee feels like going to have a charley horse any minute [charley horse] did not get any benefit from the shots [device ineffective].Rash [rash].Chills [chills].Microalbuminuria [microalbuminuria].Sense of knee locking [knee lock].Case narrative: based on additional information received on 03-may-2018 from a physician, this case became medically confirmed.This unsolicited legal case from united states was received on 02-feb-2018 from pt.This case concerns a 61 year old female pt who received trt with synvisc one and sulfamethoxazole/trimethoprim (bactrim) and after few hours pt she had swelling/both of her knees are quite swollen, experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee/posterior pain; after unk latency pt could not walk, leg did not pass range of mobility test/lacks about 2 degrees of extension/cannot fully straighten out her knees getting tighter and tighter and did not get any benefit from the shots (device ineffective), knees getting tighter and tighter/everything feels too tight, pseudohypersensitivity response/pseudo hypersensitivity reaction to bilateral synvisc injection given to knees/sensitivity, flexing her right foot caused extreme pain in her knee/ radiation of pain to dorsum of foot, bladder tumor, discomfort, back of her right knee feels like going to have a charley horse any minute, rash, chills, microalbuminuria (latency: unk), fluid was drawn off the right knee/aspirated knee fluid/effusion aspirating 3 cc fluid/right knee effusion (latency: 9 dys); sense of knee locking (latency: unk) also, device malfunction was identified for reported lot number.Pt had received synvisc one on two separate occasions in past without problem.Medical history included liver disease, diabetes mellitus type ii, long standing history of advanced osteoarthritis and bone on bone bilateral knee.Pt does not have any artificial joints, heart valves, pacemaker, or defibrillator.Pt denied allergies to avian proteins, birds, eggs, or feathers.Family history included breast carcinoma.Breast cancer (at age of 72), dementia and hypertension (mother), myocardial infraction (at age of 52), diabetes mellitus type 2, early coronary disease (father), pulmonary embolus, diabetes mellitus type 2, overweight and sedentary (brother, died) and bladder cancer (uncle), strong family history of stones (more in males), colon cancer (grand-mother).Family history also included high blood pressure, heart attack and other heart problems, hypercoagulable state and alzheimer disease (mother, maternal uncle and aunt).Pt's medical history included peptic ulcer, heart problems, hyperlipidemia, pulmonary nodule (2012), incomplete bladder emptying, recurrent uti's (since 2014), bladder stones, nephrolithiasis (2000), anterior vaginal prolapse, hysterectomy, type 2 diabetes of about 6 to 7 years duration.Moderate control with hemoglobin a1c of 7.7%, on metformin monotherapy, bilateral knee pain, left meniscal tear, osteopenia (at the hips), non-alcoholic steatohepatitis, stage 3 fibrosis, nausea, cholecystectomy, anemia, exposure keratopathy left>right, tonsillectomy, frenectomy, myalgia after multiple doses of succinylcholine.Pt was allergic to pethidine (meperidine) (itching, pruritus, throat tightness), pneumococcal vaccine (swelling throat and arm), pethidine hydrochloride (demerol) (swelling throat), nausea, elevated liver enzymes, self- catherization, hematuria, nycturia, erythema on bladder wall, neurogenic bladder, laparoscopic cholecystectomy, glaucoma, baker's cyst left leg, vaginal hysterectomy, retinopathy, mild microalbuminuria, gerd, partial lipodystrophy, fatty liver, abdominal distention and bloating, abdominal pain in right side with no radiation, never smoked, used birth control pills, frequent urination, blood in urine, fatigue, tuberculosis, one pregnancy, psychological insomnia, primary snoring, bilateral chest wall pain, hypertriglyceridemia, right knee advanced degenerative joint disorder, moderate degenerative joint disorder, left knee, buttock and hip region discomfort, single episode of kidney stone passage 8 years ago, elevated urine albumin/ creatinine ration, several episodes of postmenopausal bleeding, vaginal spotting, stress incontinence (urine), actinic keratosis, inflamed seborrheic keratosis vertex scalp, spider angioma central chest, solar keratosis right calf, asteatosis, forearm pruritus, hypovitaminosis d, hypertension, elevated alkaline phosphatase, increased hepatic steatosis and splenomegaly, fecal incontinence, overactive bladder symptoms, history of pelvic floor repairs and anti-continence procedures, mild degenerative joint disease of the left ankle with synovitis, recurrent rectocele, atypical angina, history of infertility, high blood pressure, hot flashes, very anxious, vaginal atrophy, abnormal molecular left brest imaging, abnormal bladder sensation, vaginal band, voiding dysfunction, reconstructive surgery, de novo dyspareunia, right flank pain, back pain, right pyelonephritis, pancreatitis, enlarged uterus, uterine fibroid, irregular menses, fibro glandular breast, perimenopause, ovarian cyst, probable irritable bowel syndrome, uterine and bladder descensus, loose stools, chronic dyspepsia, sigmoid diverticulosis, oligomenorrhea secondary to no.1, atypical chest pain (retrosternal), stress echocardiogram, painful menstrual pain, alopecia, hypertrichosis, migraines, gastroesophageal reflux, occasional diarrhea, occasional panic attacks, elevated blood glucose, dry skin with xerosis, prominent tibial tubercles, hair loss, arthralgias and low-grade fever, lesions on left side of her face, bony growth, bumps on her knee, pt had high risk of developing breast carcinoma due to family history of breast cancer in her mom and one out of three maternal aunts.Vaccine administration included tetanus toxoid (tetanus), acellular pertussis.Pt had failed pessary fitting.Pt had decreased urine calcium, dull headache, disequilibrium, more going around corners than orthostatic, hypercalciuria, osteopenia, steatohepatitus.Concurrent conditions included nash fibrosis (stage three hepatic fibrosis).Surgical history included lysis of a miniarc and align pubovaginal sling lysis surgery (b)(6) 2009, cholecystectomy, hysterectomy, cystoscopy, total vaginal hysterectomy with morcellation, bilateral salpingo-oophorectomy and cystoscopy, laparoscopic tubal ligation.On (b)(6) 2011, pt had synvisc one injection in right knee joint without complication.On (b)(6) 2013, pt received dep-medrol injection in left ankle joint (however, sinus tarsi region was injected).On (b)(6) 2013, pt underwent laryngoscopy.Concomitant medications included alphagan, aspirin, ciprofloxacin (cipro), cyanocobalamin (vitamin b12), adenosine (tricor), metformin hydrochloride (glucophage), lipitor, maltonin, pioglitazone, ascorbic acid (vitamin c), zantac, baby aspirin.On (b)(6) 2014, pt received synvisc one injection in right knee joint.On (b)(6) 2015, pt received depo-medrol injection in the left knee.On (b)(6) 2015, pt received synvisc one injection in right knee.On (b)(6) 2017, pt underwent mammography and breast mri both were unremarkable.On (b)(6) 2017, both knee 4vw/stdg w/patellar/ p aflex and results showed degenerative arthritis both knees with medical compartmental narrowing.Small left knee joint effusion or synovitis.Prominent spurring of the tubercles bilaterally.The same dy, pt received synvisc injections in both knees.On (b)(6) 2017, pt underwent ct urogram (ct abdomen and pelvis) showed tiny stones in the lower pole of the left kidney was unchanged, the tiny bladder stones were no longer present.Calcified granuloma left lung base.On (b)(6) 2017, pt underwent nm spine that showed osteopenia and probability of fracture was major osteoporotic 11% and hip fracture 2.0%.On (b)(6) 2017, urine sample was collected which showed calcium oxalate crystals high, brushite crystals and hydroxyapatite crystals, cystoscopy showed suspicious lesions or masses in bladder.There were very small 1 mm bladder stones floating in bladder.Cystocele evident in cystoscopy.Pt was scheduled for a surgery of cystocele.Pt had to evident uti, overweight, medically complicated obesity.Pt denied alcohol 25 years ago due to nash.On (b)(6) 2017, visited a doctor because her rash on breast (nummular rash on left brest upper inner quadrant) was quite pronounced but she had no breast masses, nipple discharge or rash anywhere else on her body.Pt concluded it as yeast infection and prescribed nystatin.On (b)(6) 2017, at 2:30 pm pt initiated trt with single intra-articular synvisc one injection, once at the dose of 6 ml (lot number: 7rsl021; expiry date: not reported) bilaterally for knee osteoarthritis (oa).Following the administration, as pt was traveling the 10-hour ride home, pt began to experience progressive pain after about 3 hours particularly in right knee during the car ride.The pain was posterior.At no time pt developed fever or other symptoms suggestive of infection.First it was thought to be pseudo hypersensitivity response sometime seen with synvisc injection, despite prior lack of reactivity.Pt was using ice, as she had with past injections.The ice was not helping.The pain became more intense and she had swelling.Both knees were in pain, but right knee hurt more.Flexing her right foot caused extreme pain in her knee as did putting pressure behind the knee.She said she had much less pain in the left knee and left knee did not swell.The pain became so excruciating that pt "had no choice but to go to er.Pt could not walk at that point due to pain and swelling.At the er, pt had to be put in a wheelchair.They put ace wraps on both knees and gave her walker, along with 12 tablets of cyclobenzaprine hydrochloride (flexeril), 10 mg tid and 12 tabs of tramadol hydrochloride (tramadol) 50 mg every 6 hours as needed.Pt's right knee was not hot or red and most of the swelling was gone.She still needed a walker to ambulate and pain was still 10/10.Her left leg had some pain but was not giving her a problem.The same dy, pt called to inform pt had rash but as per dermatology the rash did not looked worrisome for breast cancer.Advised pt to apply nystatin as discussed for one week.Vital included: temperature tympanic as 97.6 f (low) and systolic blood pressure 154 mm hg (high).X-ray knee (3 views; multiple digital radiographic projections) showed moderate osteophyte formation involving all three joint compartments, medial narrowing of medial joint compartment, moderately severe osteoarthritis; venous doppler of lower extremity showed no venous thrombosis of right lower extremity.They ran tests and ruled out a blood clot and sent her home with a walker.The doctor sent a steroid medication to help the swelling.On an unk date, after unk latency pt had discomfort.On (b)(6) 2018, pt reported things got worse.Her pain woke her up in middle of the night last night and both of her knees were quite swollen.Yesterdy with lying down her pain was 4/10-5/10 and now it was 6/10.Pt was icing her knees and she cannot fully straighten out her knee than the left knee.She continued to use ace wraps.She said that the walking with her walker has a pain of 9.She stated that the back of her knee felt like she was going to have charley horse any minute (onset: (b)(6) 2017; latency: unk).The interaction of tramadol hydrochloride (tramadol), cyclobenzaprine hydrochloride (flexeril)was studied and it was found that can cause respiratory problems when used in combination so told to stop.On (b)(6) 2017, pt had not quieted down with initial trt rendered by a local emergency room.Pt was recommended methylprednisolone (medrol) dose pack, use of walker until she could ambulate without discomfort, no further synvisc-one injection.The same dy pt was informed that her urine cytology was negative for high grade urothelial carcinoma.It took almost 2 weeks at home to get the leg to function normally.On (b)(6) 2017, swelling was gone and other than occasional very minor twinges, the pain was gone.Pt was walking normally without a walker.Pt was slowly extending time and distance she was walking.She was then pt got a call on (b)(6) 2017 about 5 pm from doctor informing her that the synvisc one pt received was contaminated.It was the understanding that she received recalled product in both knees.The physician asked her to travel back the next dy.Pt made the 10-hour trip back.The doctor was concerned that the steroids she had given the might suppress her immune system's ability to fight a possible infection.At office on (b)(6) 2017, 9 dys after receiving trt with synvisc one injection, fluid was drawn/aspirated off the right knee only.Effusion aspirating 3 cc fluid/right knee effusion.Pt's right knee was aspirated under ultrasound guidance.There were 1109 nucleated cells with only 27 % of them being neutrophils.There was no chance that this represents fluid with infection.The leg did not pass the range of mobility tests.It lacks about 2 degrees of extension and could not fully straighten out her knees getting tighter and tighter.Pt and her husband stayed in a hotel for a couple nights.Then pt went home.Pt heard that the preliminary test of the fluid was okay.Then about 2 weeks ago pt received word that the last culture would be okay.It was "a huge inconvenience and expense for us." pt expressed that she can usually endure pain rather well, but this pain was far beyond anything she could endure.Pt was also frustrated that when the fluid was removed, it also removed the synvisc.Therefore, she did not get any benefit from the shot/s.Pt was not currently using a walker.The symptoms were the same as prior to injection-her right knee hurts more when exercising, she used a leg brace and was icing.It was reported that pt had no relief.It affected her life a lot being immobile for two weeks.Pt was very concerned about potential long-term effects.On (b)(6) 2017, pt's culture of the aspirated knee fluid showed no evidence aerobic or anaerobic growth.Pt had some soreness in her knee with some swelling noted posteriorly from time to time.On (b)(6) 2018, pt underwent cystoscopy, biopsy, fulguration bladder tumor, possible urinary catheter placement for.Pt was diagnosed with microalbuminuria and wanted to start lisinopril.Pt wanted to know if lisinopril was the standard trt for the diabetic pt with protein in urine.Pt also had kidney stone condition.Pt had been requested to underwent urine testing prior to surgery as pt had history of uti's.Pt had an outside urinalysis and culture done.Her urinalysis was considered positive and pt was then put on bactrim for 3 dy until the culture came back.On an unk date, after unk latency, pt had rash from the sulfamethoxazole/trimethoprim (dose, form, route and frequency: unk) and her local provider changes the antibiotic to cipro.Final culture showed it was contamination (contaminant staph epidermidis with 25000 to 50,000 colony forming units) versus actual infection.Pt had taken the antibiotics for the positive urinalysis she felt chills (onset: unk; latency: unk) and was not well but denied any urinary symptoms.Pt was concerned about the chills if there was something viral going on and would like to postpone surgery.On an unk date, the patient had swelling at the posterior aspect of right knee, was also popping of her knee, there was also a sense of knee locking such as at night when she extended knee to allow motion.On an unknow date, the patient complained of radiation of pain to dorsum of foot.Action taken: drug withdrawn nos for sulfamethoxazole/trimethoprim corrective trt: wheelchair and walker for could not walk; steroid injection, methylprednisolone (medrol) dose pack, walker, tramadol hydrochloride (tramadol), cyclobenzaprine hydrochloride (flexeril) for she had swelling/both of her knees are quite swollen; ice and leg brace, methylprednisolone, walker, tramadol hydrochloride, cyclobenzaprine hydrochloride for began to experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee; walker for knees getting tighter and tighter/everything feels too tight; methylprednisolone and use of walker for pseudo hypersensitivity response/pseudo hypersensitivity reaction to bilateral synvisc injection given to knees/sensitivity; walking, tramadol hydrochloride and cyclobenzaprine hydrochloride for flexing her right foot caused extreme pain in her knee; lisinopril for microalbuminuria; not reported for rest outcome: recovered/ resolved for she had swelling/both of her knees are quite swollen, experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee/posterior pain; unk for rest all events a global pharmaceutical technical complaint was initiated with gptc number: 52393 an investigation was initiated as a result of an unexpected increase in number of labelled 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 unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, presence of microbial contamination was also confirmed.Cause of these events was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness: disability for device malfunction could not walk, knees getting tighter and tighter/everything feels too tight, pseudo hypersensitivity response/pseudo hypersensitivity reaction to the bilateral synvisc injection given to knees/sensitivity, experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee, flexing her right foot caused extreme pain in her knee; required intervention and disability for she had swelling/both of her knees are quite swollen; medically significant for bladder tumor info recvd on (b)(6) 2018.The gptc number was added.Info recvd on 03-may-2018 from a physician.This case became medically confirmed.Additional events knees getting tighter and tighter/everything feels too tight, pseudo hypersensitivity response/pseudo hypersensitivity reaction to bilateral synvisc injection given to knees/sensitivity, flexing her right foot caused extreme pain in her knee, bladder tumor, discomfort, back of her right knee feels like going to have a charley horse any minute, rash, chills, microalbuminuria along with details were added.Event term she had swelling was updated to she had swelling/both of her knees are quite swollen and its corrective trt was added and its seriousness criteria was updated as disability and its outcome was updated as resolved.Event term experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising was updated to experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee, its seriousness criteria was updated as disability and outcome was updated as recovered/ resolved and corrective trts were added.Event term fluid was drawn off the right knee was updated to fluid was drawn off right knee/aspirated knee fluid/effusion aspirating 3 cc fluid/right knee effusion and leg did not pass the range of mobility test was updated to leg did not pass range of mobility test/lacks about 2 degrees of extension/cannot fully straighten out her knees getting tighter and tighter.Medical history, past drugs, concurrent conditions, family history and concomitant medications were added.Additional suspect product sulfamethoxazole/trimethoprim was added.Info recvd 21-may-2018 from physician.Medical history was updated.Lab data was added.Info rcvd on 13feb2019 from lawyer.Event of sense of knee locking added.Verbatim updated for the event of experience pain/pain became so excruciating /both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee/posterior pain and event of flexing her right foot caused extreme pain in her knee/radiation of pain to dorsum of foot.
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Event Description
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Device malfunction [device malfunction] could not walk [difficulty in walking] knees getting tighter and tighter/everything feels too tight [joint stiffness] she had swelling/both of her knees are quite swollen [knee swelling] pseudohypersensitivity response/pseudohypersensitivity reaction to the bilateral synvisc injection given to knees/sensitivity [pseudosepsis] experience pain/pain became so excruciating /both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising /soreness in knee [knee pain] ([condition worsened]) flexing her right foot caused extreme pain in her knee [pain upon movement] bladder tumor [bladder cancer nos] fluid was drawn off the right knee/aspirated knee fluid/effusion aspirating 3 cc fluid/right knee effusion [knee effusion] leg did not pass the range of mobility test/lacks about 2 degrees of extension/cannot fully straighten out her knees getting tighter and tighter [joint range of motion decreased] discomfort [discomfort] back of her right knee feels like going to have a charley horse any minute [charley horse] did not get any benefit from the shots [device ineffective] rash [rash] chills [chills] microalbuminuria [microalbuminuria] case narrative: based on additional information received on (b)(6) 2018 from a physician, this case became medically confirmed.This unsolicited legal case from united states was received on (b)(6) 2018 from pt.This case concerns a 61 year old female pt who received trt with synvisc one and sulfamethoxazole/trimethoprim (bactrim) and after few hours pt she had swelling/both of her knees are quite swollen, experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee; after unk latency pt could not walk, leg did not pass the range of mobility test/lacks about 2 degrees of extension/cannot fully straighten out her knees getting tighter and tighter and did not get any benefit from the shots (device ineffective), knees getting tighter and tighter/everything feels too tight, pseudohypersensitivity response/pseudo hypersensitivity reaction to the bilateral synvisc injection given to knees/sensitivity, flexing her right foot caused extreme pain in her knee, bladder tumor, discomfort, back of her right knee feels like going to have a charley horse any minute, rash, chills, microalbuminuria (latency: unk), fluid was drawn off the right knee/aspirated knee fluid/effusion aspirating 3 cc fluid/right knee effusion (latency: 9 dys); also, device malfunction was identified for the reported lot number.Pt had received synvisc one on two separate occasions in the past without problem.Medical history included liver disease, diabetes mellitus type ii, long standing history of advanced osteoarthritis and bone on bone bilateral knee.Pt does not have any artificial joints, heart valves, pacemaker, or defibrillator.Pt denied allergies to avian proteins, birds, eggs, or feathers.Family history included breast carcinoma.Breast cancer (at age of 72), dementia and hypertension (mother), myocardial infraction (at age of 52), diabetes mellitus type 2, early coronary disease (father), pulmonary embolus, diabetes mellitus type 2, overweight and sedentary (brother, died) and bladder cancer (uncle), strong family history of stones (more in males), colon cancer (grand-mother).Family history also included high blood pressure, heart attack and other heart problems, hypercoagulable state and alzheimer disease (mother, maternal uncle and aunt).Pt's medical history included peptic ulcer, heart problems, hyperlipidemia, pulmonary nodule (2012), incomplete bladder emptying, recurrent uti's (since 2014), bladder stones, nephrolithiasis (2000), anterior vaginal prolapse, hysterectomy, type 2 diabetes of about 6 to 7 years duration.Moderate control with hemoglobin a1c of 7.7%, on metformin monotherapy, bilateral knee pain, left meniscal tear, osteopenia (at the hips), non-alcoholic steatohepatitis, stage 3 fibrosis, nausea, cholecystectomy, anemia, exposure keratopathy left>right, tonsillectomy, frenectomy, myalgia after multiple doses of succinylcholine.Pt was allergic to pethidine (meperidine) (itching, pruritus, throat tightness), pneumococcal vaccine (swelling throat and arm), pethidine hydrochloride (demerol) (swelling throat), nausea, elevated liver enzymes, self- catherization, hematuria, nycturia, erythema on bladder wall, neurogenic bladder, laparoscopic cholecystectomy, glaucoma, baker's cyst left leg, vaginal hysterectomy, retinopathy, mild microalbuminuria, gerd, partial lipodystrophy, fatty liver, abdominal distention and bloating, abdominal pain in right side with no radiation, never smoked, used birth control pills, frequent urination, blood in urine, fatigue, tuberculosis, one pregnancy, psychological insomnia, primary snoring, bilateral chest wall pain, hypertriglyceridemia, right knee advanced degenerative joint disorder, moderate degenerative joint disorder, left knee, buttock and hip region discomfort, single episode of kidney stone passage 8 years ago, elevated urine albumin/ creatinine ration, several episodes of postmenopausal bleeding, vaginal spotting, stress incontinence (urine), actinic keratosis, inflamed seborrheic keratosis vertex scalp, spider angioma central chest, solar keratosis right calf, asteatosis, forearm pruritus, hypovitaminosis d, hypertension, elevated alkaline phosphatase, increased hepatic steatosis and splenomegaly, fecal incontinence, overactive bladder symptoms, history of pelvic floor repairs and anti-continence procedures, mild degenerative joint disease of the left ankle with synovitis, recurrent rectocele, atypical angina, history of infertility, high blood pressure, hot flashes, very anxious, vaginal atrophy, abnormal molecular left brest imaging, abnormal bladder sensation, vaginal band, voiding dysfunction, reconstructive surgery, de novo dyspareunia, right flank pain, back pain, right pyelonephritis, pancreatitis, enlarged uterus, uterine fibroid, irregular menses, fibro glandular breast, perimenopause, ovarian cyst, probable irritable bowel syndrome, uterine and bladder descensus, loose stools, chronic dyspepsia, sigmoid diverticulosis, oligomenorrhea secondary to no.1, atypical chest pain (retrosternal), stress echocardiogram, painful menstrual pain, alopecia, hypertrichosis, migraines, gastroesophageal reflux, occasional diarrhea, occasional panic attacks, elevated blood glucose, dry skin with xerosis, prominent tibial tubercles, hair loss, arthralgias and low-grade fever, lesions on the left side of her face, bony growth, bumps on her knee, pt had high risk of developing breast carcinoma due to family history of breast cancer in her mom and one out of three maternal aunts.Vaccine administration included tetanus toxoid (tetanus), acellular pertussis.Pt had failed pessary fitting.Pt had decreased urine calcium, dull headache, disequilibrium, more going around corners than orthostatic, hypercalciuria, osteopenia, steatohepatitus.Concurrent conditions included nash fibrosis (stage three hepatic fibrosis).Surgical history included lysis of a miniarc and align pubovaginal sling lysis surgery (b)(6) 2009, cholecystectomy, hysterectomy, cystoscopy, total vaginal hysterectomy with morcellation, bilateral salpingo-oophorectomy and cystoscopy, laparoscopic tubal ligation.On 04-feb-2011, pt had synvisc one injection in right knee joint without complication.On 23-feb-2013, pt received dep-medrol injection in left ankle joint (however, sinus tarsi region was injected).On 05-aug-2013, pt underwent laryngoscopy.Concomitant medications included alphagan, aspirin, ciprofloxacin (cipro), cyanocobalamin (vitamin b12), adenosine (tricor), metformin hydrochloride (glucophage), lipitor, maltonin, pioglitazone, ascorbic acid (vitamin c), zantac, baby aspirin.On (b)(6) 2014, pt received synvisc one injection in the right knee joint.On (b)(6) 2015, pt received depo-medrol injection in the left knee.On (b)(6) 2015, pt received synvisc one injection in the right knee.On (b)(6) 2017, pt underwent mammography and breast mri both were unremarkable.On (b)(6) 2017, both knee 4vw/stdg w/patellar/ p aflex and results showed degenerative arthritis both knees with medical compartmental narrowing.Small left knee joint effusion or synovitis.Prominent spurring of the tubercles bilaterally.The same dy, pt received synvisc injections in both knees.On (b)(6) 2017, pt underwent ct urogram (ct abdomen and pelvis) showed tiny stones in the lower pole of the left kidney was unchanged, the tiny bladder stones were no longer present.Calcified granuloma left lung base.On (b)(6) 2017, pt underwent nm spine that showed osteopenia and probability of fracture was major osteoporotic 11% and hip fracture 2.0%.On (b)(6) 2017, urine sample was collected which showed calcium oxalate crystals high, brushite crystals and hydroxyapatite crystals, cystoscopy showed suspicious lesions or masses in the bladder.There were very small 1 mm bladder stones floating in the bladder.Cystocele evident in the cystoscopy.Pt was scheduled for a surgery of cystocele.Pt had to evident uti, overweight, medically complicated obesity.Pt denied alcohol 25 years ago due to nash.On 05-dec-2017, pt visited a doctor because her rash on breast (nummular rash on left brest upper inner quadrant) was quite pronounced but she had no breast masses, nipple discharge or rash anywhere else on her body.Pt concluded it as yeast infection and prescribed nystatin.Pt's current employment status was work-disabled.Denied history of deep vein thrombosis or pulmonary embolism.On 5dec17, at 2:30 pm pt initiated trt with single intra-articular synvisc one injection, once at the dose of 6 ml (lot number: 7rsl021; expiry date: not reported) bilaterally for knee osteoarthritis (oa).Following the administration, as pt was traveling the 10-hour ride home, pt began to experience progressive pain after about 3 hours particularly in the right knee during the car ride.The pain was posterior.At no time pt developed fever or other symptoms suggestive of infection.First it was thought to be pseudo hypersensitivity response sometime seen with synvisc injection, despite prior lack of reactivity.Pt was using ice, as she had with past injections.The ice was not helping.The pain became more intense and she had swelling.Both knees were in pain, but the right knee hurt more.Flexing her right foot caused extreme pain in her knee as did putting pressure behind the knee.She said she had much less pain in the left knee and left knee did not swell.The pain became so excruciating that pt "had no choice but to go to er.Pt could not walk at that point due to the pain and swelling.At the er, pt had to be put in a wheelchair.They put ace wraps on both knees and gave her walker, along with 12 tablets of cyclobenzaprine hydrochloride (flexeril), 10 mg tid and 12 tabs of tramadol hydrochloride (tramadol) 50 mg every 6 hours as needed.Pt's right knee was not hot or red and most of the swelling was gone.She still needed a walker to ambulate and the pain was still 10/10.Her left leg had some pain, but was not giving her a problem.The same dy, pt called to inform pt had rash but as per dermatology the rash did not looked worrisome for breast cancer.Advised pt to apply nystatin as discussed for one week.Vital included: temperature tympanic as 97.6 f (low) and systolic blood pressure 154 mm hg (high).X-ray knee (3 views; multiple digital radiographic projections) showed moderate osteophyte formation involving all three joint compartments, medial narrowing of medial joint compartment, moderately severe osteoarthritis; venous doppler of lower extremity showed no venous thrombosis of right lower extremity.They ran tests and ruled out a blood clot and sent her home with a walker.The doctor sent a steroid medication to help the swelling.On an unk date, after unk latency pt had discomfort.On 07-dec-2018, pt reported things got worse.Her pain woke her up in the middle of the night last night and now both of her knees were quite swollen.Yesterdy with lying down her pain was 4/10-5/10 and now it was 6/10.Pt was icing her knees and she cannot fully straighten out her knee than the left knee.She continued to use ace wraps.She said that the walking with her walker has a pain of 9.She stated that the back of her knee felt like she was going to have charley horse any minute (onset: dec-2017; latency: unk).The interaction of tramadol hydrochloride (tramadol), cyclobenzaprine hydrochloride (flexeril)was studied and it was found that can cause respiratory problems when used in combination so told to stop.On 07-dec-2017, pt had not quieted down with initial trt rendered by a local emergency room.Pt was recommended methylprednisolone (medrol) dose pack, use of walker until she could ambulate without discomfort, no further synvisc-one injection.The same dy pt was informed that her urine cytology was negative for high grade urothelial carcinoma.It took almost 2 weeks at home to get the leg to function normally.On 11-dec-2017, pt's swelling was gone and other than occasional very minor twinges, the pain was gone.Pt was walking normally without a walker.Pt was slowly extending time and distance she was walking.She was then pt got a call on 13-dec-2017 about 5 pm from the doctor informing her that the synvisc one pt received was contaminated.It was the understanding that she received recalled product in both knees.The physician asked her to travel back the next dy.Pt made the 10-hour trip back.The doctor was concerned that the steroids she had given the might suppress her immune system's ability to fight a possible infection.At the office on 14-dec-2017, 9 dys after receiving trt with synvisc one injection, fluid was drawn/aspirated off the right knee only.Effusion aspirating 3 cc fluid/right knee effusion.Pt's right knee was aspirated under ultrasound guidance.There were 1109 nucleated cells with only 27 % of them being neutrophils.There was no chance that this represents fluid with infection.The leg did not pass the range of mobility tests.It lacks about 2 degrees of extension and could not fully straighten out her knees getting tighter and tighter.Pt and her husband stayed in a hotel for a couple nights.Then pt went home.Pt heard that the preliminary test of the fluid was okay.Then about 2 weeks ago pt received word that the last culture would be okay.It was "a huge inconvenience and expense for us." pt expressed that she can usually endure pain rather well, but this pain was far beyond anything she could endure.Pt was also frustrated that when the fluid was removed, it also removed the synvisc.Therefore, she did not get any benefit from the shot/s.Pt was not currently using a walker.The symptoms were the same as prior to injection-her right knee hurts more when exercising, she used a leg brace and was icing.It was reported that pt had no relief.It affected her life a lot being immobile for two weeks.Pt was very concerned about potential long-term effects.On 28dec17, pt's culture of the aspirated knee fluid showed no evidence aerobic or anaerobic growth.Pt had some soreness in her knee with some swelling noted posteriorly from time to time.On 29jan18, pt underwent cystoscopy, biopsy, fulguration bladder tumor, possible urinary catheter placement for.Pt was diagnosed with microalbuminuria and wanted to start lisinopril.Pt wanted to know if lisinopril was the standard trt for the diabetic pt with protein in urine.Pt also had kidney stone condition.Pt had been requested to underwent urine testing prior to surgery as pt had history of uti's.Pt had an outside urinalysis and culture done.Her urinalysis was considered positive and pt was then put on bactrim for 3 dy until the culture came back.On an unk date, after unk latency, pt had rash from the sulfamethoxazole/trimethoprim (dose, form, route and frequency: unk) and her local provider changes the antibiotic to cipro.Final culture showed it was contamination (contaminant staph epidermidis with 25000 to 50,000 colony forming units) versus actual infection.Pt had taken the antibiotics for the positive urinalysis she felt chills (onset: unk; latency: unk) and was not well but denied any urinary symptoms.Pt was concerned about the chills if there was something viral going on and would like to postpone surgery.Action taken: drug withdrawn nos for sulfamethoxazole/trimethoprim corrective trt: wheelchair and walker for could not walk; steroid injection, methylprednisolone (medrol) dose pack, walker, tramadol hydrochloride (tramadol), cyclobenzaprine hydrochloride (flexeril) for she had swelling/both of her knees are quite swollen; ice and leg brace, methylprednisolone, walker, tramadol hydrochloride, cyclobenzaprine hydrochloride for began to experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee; walker for knees getting tighter and tighter/everything feels too tight; methylprednisolone and use of walker for pseudo hypersensitivity response/pseudo hypersensitivity reaction to the bilateral synvisc injection given to knees/sensitivity; walking, tramadol hydrochloride and cyclobenzaprine hydrochloride for flexing her right foot caused extreme pain in her knee; lisinopril for microalbuminuria; not reported for rest outcome: recovered/ resolved for she had swelling/both of her knees are quite swollen, experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee; unk for rest all events a global pharmaceutical technical complaint was initiated with gptc number: 52393 an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness: disability for device malfunction could not walk, knees getting tighter and tighter/everything feels too tight, pseudo hypersensitivity response/pseudo hypersensitivity reaction to the bilateral synvisc injection given to knees/sensitivity, experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee, flexing her right foot caused extreme pain in her knee; required intervention and disability for she had swelling/both of her knees are quite swollen; medically significant for bladder tumor info recvd on 12-feb-2018.The gptc number was added.Info recvd on 03-may-2018 from a physician.This case became medically confirmed.Additional events knees getting tighter and tighter/everything feels too tight, pseudo hypersensitivity response/pseudo hypersensitivity reaction to the bilateral synvisc injection given to knees/sensitivity, flexing her right foot caused extreme pain in her knee, bladder tumor, discomfort, back of her right knee feels like going to have a charley horse any minute, rash, chills, microalbuminuria along with details were added.Event term she had swelling was updated to she had swelling/both of her knees are quite swollen and its corrective trt was added and its seriousness criteria was updated as disability and its outcome was updated as resolved.Event term experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising was updated to experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee, its seriousness criteria was updated as disability and outcome was updated as recovered/ resolved and corrective trts were added.Event term fluid was drawn off the right knee was updated to fluid was drawn off the right knee/aspirated knee fluid/effusion aspirating 3 cc fluid/right knee effusion and leg did not pass the range of mobility test was updated to leg did not pass the range of mobility test/lacks about 2 degrees of extension/cannot fully straighten out her knees getting tighter and tighter.Medical history, past drugs, concurrent conditions, family history and concomitant medications were added.Additional suspect product sulfamethoxazole/trimethoprim was added.Clinical course was updated and text was amended accordingly.Info recvd (b)(6) 2018 from the physician.Medical history was updated.Lab data was added.Clinical course was updated and text was amended accordingly.
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Event Description
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Device malfunction [device malfunction] could not walk [difficulty in walking] knees getting tighter and tighter/everything feels too tight [joint stiffness] she had swelling/both of her knees are quite swollen [knee swelling] pseudohypersensitivity response/pseudohypersensitivity reaction to the bilateral synvisc injection given to knees/sensitivity [pseudosepsis] experience pain/pain became so excruciating /both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising /soreness in knee/ posterior pain [knee pain] ([condition worsened]) flexing her right foot caused extreme pain in her knee/radiation of pain to dorsum of foot [pain upon movement] bladder tumor [bladder cancer nos] fluid was drawn off the right knee/aspirated knee fluid/effusion aspirating 3 cc fluid/right knee effusion [knee effusion] leg did not pass the range of mobility test/lacks about 2 degrees of extension/cannot fully straighten out her knees getting tighter and tighter [joint range of motion decreased] discomfort [discomfort] back of her right knee feels like going to have a charley horse any minute [charley horse] did not get any benefit from the shots [device ineffective] rash [rash] chills [chills] microalbuminuria [microalbuminuria] sense of knee locking [knee lock] case narrative: based on additional information received on (b)(6) 2018 from a physician, this case became medically confirmed.This unsolicited legal case from united states was received on (b)(6) 2018 from pt.This case concerns a 61 year old female pt who received trt with synvisc one and sulfamethoxazole/trimethoprim (bactrim) and after few hours pt she had swelling/both of her knees are quite swollen, experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee/posterior pain; after unk latency pt could not walk, leg did not pass range of mobility test/lacks about 2 degrees of extension/cannot fully straighten out her knees getting tighter and tighter and did not get any benefit from the shots (device ineffective), knees getting tighter and tighter/everything feels too tight, pseudohypersensitivity response/pseudo hypersensitivity reaction to bilateral synvisc injection given to knees/sensitivity, flexing her right foot caused extreme pain in her knee/ radiation of pain to dorsum of foot, bladder tumor, discomfort, back of her right knee feels like going to have a charley horse any minute, rash, chills, microalbuminuria (latency: unk), fluid was drawn off the right knee/aspirated knee fluid/effusion aspirating 3 cc fluid/right knee effusion (latency: 9 dys); sense of knee locking (latency: unk) also, device malfunction was identified for reported lot number.Pt had received synvisc one on two separate occasions in past without problem.Medical history included liver disease, diabetes mellitus type ii, long standing history of advanced osteoarthritis and bone on bone bilateral knee.Pt does not have any artificial joints, heart valves, pacemaker, or defibrillator.Pt denied allergies to avian proteins, birds, eggs, or feathers.Family history included breast carcinoma.Breast cancer (at age of 72), dementia and hypertension (mother), myocardial infraction (at age of 52), diabetes mellitus type 2, early coronary disease (father), pulmonary embolus, diabetes mellitus type 2, overweight and sedentary (brother, died) and bladder cancer (uncle), strong family history of stones (more in males), colon cancer (grand-mother).Family history also included high blood pressure, heart attack and other heart problems, hypercoagulable state and alzheimer disease (mother, maternal uncle and aunt).Pt's medical history included peptic ulcer, heart problems, hyperlipidemia, pulmonary nodule (2012), incomplete bladder emptying, recurrent uti's (since 2014), bladder stones, nephrolithiasis (2000), anterior vaginal prolapse, hysterectomy, type 2 diabetes of about 6 to 7 years duration.Moderate control with hemoglobin a1c of 7.7%, on metformin monotherapy, bilateral knee pain, left meniscal tear, osteopenia (at the hips), non-alcoholic steatohepatitis, stage 3 fibrosis, nausea, cholecystectomy, anemia, exposure keratopathy left>right, tonsillectomy, frenectomy, myalgia after multiple doses of succinylcholine.Pt was allergic to pethidine (meperidine) (itching, pruritus, throat tightness), pneumococcal vaccine (swelling throat and arm), pethidine hydrochloride (demerol) (swelling throat), nausea, elevated liver enzymes, self- catherization, hematuria, nycturia, erythema on bladder wall, neurogenic bladder, laparoscopic cholecystectomy, glaucoma, baker's cyst left leg, vaginal hysterectomy, retinopathy, mild microalbuminuria, gerd, partial lipodystrophy, fatty liver, abdominal distention and bloating, abdominal pain in right side with no radiation, never smoked, used birth control pills, frequent urination, blood in urine, fatigue, tuberculosis, one pregnancy, psychological insomnia, primary snoring, bilateral chest wall pain, hypertriglyceridemia, right knee advanced degenerative joint disorder, moderate degenerative joint disorder, left knee, buttock and hip region discomfort, single episode of kidney stone passage 8 years ago, elevated urine albumin/ creatinine ration, several episodes of postmenopausal bleeding, vaginal spotting, stress incontinence (urine), actinic keratosis, inflamed seborrheic keratosis vertex scalp, spider angioma central chest, solar keratosis right calf, asteatosis, forearm pruritus, hypovitaminosis d, hypertension, elevated alkaline phosphatase, increased hepatic steatosis and splenomegaly, fecal incontinence, overactive bladder symptoms, history of pelvic floor repairs and anti-continence procedures, mild degenerative joint disease of the left ankle with synovitis, recurrent rectocele, atypical angina, history of infertility, high blood pressure, hot flashes, very anxious, vaginal atrophy, abnormal molecular left brest imaging, abnormal bladder sensation, vaginal band, voiding dysfunction, reconstructive surgery, de novo dyspareunia, right flank pain, back pain, right pyelonephritis, pancreatitis, enlarged uterus, uterine fibroid, irregular menses, fibro glandular breast, perimenopause, ovarian cyst, probable irritable bowel syndrome, uterine and bladder descensus, loose stools, chronic dyspepsia, sigmoid diverticulosis, oligomenorrhea secondary to no.1, atypical chest pain (retrosternal), stress echocardiogram, painful menstrual pain, alopecia, hypertrichosis, migraines, gastroesophageal reflux, occasional diarrhea, occasional panic attacks, elevated blood glucose, dry skin with xerosis, prominent tibial tubercles, hair loss, arthralgias and low-grade fever, lesions on left side of her face, bony growth, bumps on her knee, pt had high risk of developing breast carcinoma due to family history of breast cancer in her mom and one out of three maternal aunts.Vaccine administration included tetanus toxoid (tetanus), acellular pertussis.Pt had failed pessary fitting.Pt had decreased urine calcium, dull headache, disequilibrium, more going around corners than orthostatic, hypercalciuria, osteopenia, steatohepatitus.Concurrent conditions included nash fibrosis (stage three hepatic fibrosis).Surgical history included lysis of a miniarc and align pubovaginal sling lysis surgery (b)(6) 2009, cholecystectomy, hysterectomy, cystoscopy, total vaginal hysterectomy with morcellation, bilateral salpingo-oophorectomy and cystoscopy, laparoscopic tubal ligation.On (b)(6) 2011, pt had synvisc one injection in right knee joint without complication.On (b)(6) 2013, pt received dep-medrol injection in left ankle joint (however, sinus tarsi region was injected).On (b)(6) 2013, pt underwent laryngoscopy.Concomitant medications included alphagan, aspirin, ciprofloxacin (cipro), cyanocobalamin (vitamin b12), adenosine (tricor), metformin hydrochloride (glucophage), lipitor, maltonin, pioglitazone, ascorbic acid (vitamin c), zantac, baby aspirin.On (b)(6) 2014, pt received synvisc one injection in right knee joint.On (b)(6) 2015, pt received depo-medrol injection in the left knee.On (b)(6) 2015, pt received synvisc one injection in right knee.On (b)(6) 2017, pt underwent mammography and breast mri both were unremarkable.On (b)(6) 2017, both knee 4vw/stdg w/patellar/ p aflex and results showed degenerative arthritis both knees with medical compartmental narrowing.Small left knee joint effusion or synovitis.Prominent spurring of the tubercles bilaterally.The same dy, pt received synvisc injections in both knees.On (b)(6) 2017, pt underwent ct urogram (ct abdomen and pelvis) showed tiny stones in the lower pole of the left kidney was unchanged, the tiny bladder stones were no longer present.Calcified granuloma left lung base.On (b)(6) 2017, pt underwent nm spine that showed osteopenia and probability of fracture was major osteoporotic 11% and hip fracture 2.0%.On (b)(6) 2017, urine sample was collected which showed calcium oxalate crystals high, brushite crystals and hydroxyapatite crystals, cystoscopy showed suspicious lesions or masses in bladder.There were very small 1 mm bladder stones floating in bladder.Cystocele evident in cystoscopy.Pt was scheduled for a surgery of cystocele.Pt had to evident uti, overweight, medically complicated obesity.Pt denied alcohol 25 years ago due to nash.On (b)(6) 2017, visited a doctor because her rash on breast (nummular rash on left brest upper inner quadrant) was quite pronounced but she had no breast masses, nipple discharge or rash anywhere else on her body.Pt concluded it as yeast infection and prescribed nystatin.On 5dec17, at 2:30 pm pt initiated trt with single intra-articular synvisc one injection, once at the dose of 6 ml (lot number: 7rsl021; expiry date: not reported) bilaterally for knee osteoarthritis (oa).Following the administration, as pt was traveling the 10-hour ride home, pt began to experience progressive pain after about 3 hours particularly in right knee during the car ride.The pain was posterior.At no time pt developed fever or other symptoms suggestive of infection.First it was thought to be pseudo hypersensitivity response sometime seen with synvisc injection, despite prior lack of reactivity.Pt was using ice, as she had with past injections.The ice was not helping.The pain became more intense and she had swelling.Both knees were in pain, but right knee hurt more.Flexing her right foot caused extreme pain in her knee as did putting pressure behind the knee.She said she had much less pain in the left knee and left knee did not swell.The pain became so excruciating that pt "had no choice but to go to er.Pt could not walk at that point due to pain and swelling.At the er, pt had to be put in a wheelchair.They put ace wraps on both knees and gave her walker, along with 12 tablets of cyclobenzaprine hydrochloride (flexeril), 10 mg tid and 12 tabs of tramadol hydrochloride (tramadol) 50 mg every 6 hours as needed.Pt's right knee was not hot or red and most of the swelling was gone.She still needed a walker to ambulate and pain was still 10/10.Her left leg had some pain but was not giving her a problem.The same dy, pt called to inform pt had rash but as per dermatology the rash did not looked worrisome for breast cancer.Advised pt to apply nystatin as discussed for one week.Vital included: temperature tympanic as 97.6 f (low) and systolic blood pressure 154 mm hg (high).X-ray knee (3 views; multiple digital radiographic projections) showed moderate osteophyte formation involving all three joint compartments, medial narrowing of medial joint compartment, moderately severe osteoarthritis; venous doppler of lower extremity showed no venous thrombosis of right lower extremity.They ran tests and ruled out a blood clot and sent her home with a walker.The doctor sent a steroid medication to help the swelling.On an unk date, after unk latency pt had discomfort.On 07-dec-2018, pt reported things got worse.Her pain woke her up in middle of the night last night and both of her knees were quite swollen.Yesterdy with lying down her pain was 4/10-5/10 and now it was 6/10.Pt was icing her knees and she cannot fully straighten out her knee than the left knee.She continued to use ace wraps.She said that the walking with her walker has a pain of 9.She stated that the back of her knee felt like she was going to have charley horse any minute (onset: dec-2017; latency: unk).The interaction of tramadol hydrochloride (tramadol), cyclobenzaprine hydrochloride (flexeril)was studied and it was found that can cause respiratory problems when used in combination so told to stop.On (b)(6) 2017, pt had not quieted down with initial trt rendered by a local emergency room.Pt was recommended methylprednisolone (medrol) dose pack, use of walker until she could ambulate without discomfort, no further synvisc-one injection.The same dy pt was informed that her urine cytology was negative for high grade urothelial carcinoma.It took almost 2 weeks at home to get the leg to function normally.On (b)(6) 2017, swelling was gone and other than occasional very minor twinges, the pain was gone.Pt was walking normally without a walker.Pt was slowly extending time and distance she was walking.She was then pt got a call on (b)(6) 2017 about 5 pm from doctor informing her that the synvisc one pt received was contaminated.It was the understanding that she received recalled product in both knees.The physician asked her to travel back the next dy.Pt made the 10-hour trip back.The doctor was concerned that the steroids she had given the might suppress her immune system's ability to fight a possible infection.At office on (b)(6) 2017, 9 dys after receiving trt with synvisc one injection, fluid was drawn/aspirated off the right knee only.Effusion aspirating 3 cc fluid/right knee effusion.Pt's right knee was aspirated under ultrasound guidance.There were 1109 nucleated cells with only 27 % of them being neutrophils.There was no chance that this represents fluid with infection.The leg did not pass the range of mobility tests.It lacks about 2 degrees of extension and could not fully straighten out her knees getting tighter and tighter.Pt and her husband stayed in a hotel for a couple nights.Then pt went home.Pt heard that the preliminary test of the fluid was okay.Then about 2 weeks ago pt received word that the last culture would be okay.It was "a huge inconvenience and expense for us." pt expressed that she can usually endure pain rather well, but this pain was far beyond anything she could endure.Pt was also frustrated that when the fluid was removed, it also removed the synvisc.Therefore, she did not get any benefit from the shot/s.Pt was not currently using a walker.The symptoms were the same as prior to injection-her right knee hurts more when exercising, she used a leg brace and was icing.It was reported that pt had no relief.It affected her life a lot being immobile for two weeks.Pt was very concerned about potential long-term effects.On (b)(6) 17, pt's culture of the aspirated knee fluid showed no evidence aerobic or anaerobic growth.Pt had some soreness in her knee with some swelling noted posteriorly from time to time.On (b)(6) 18, pt underwent cystoscopy, biopsy, fulguration bladder tumor, possible urinary catheter placement for.Pt was diagnosed with microalbuminuria and wanted to start lisinopril.Pt wanted to know if lisinopril was the standard trt for the diabetic pt with protein in urine.Pt also had kidney stone condition.Pt had been requested to underwent urine testing prior to surgery as pt had history of uti's.Pt had an outside urinalysis and culture done.Her urinalysis was considered positive and pt was then put on bactrim for 3 dy until the culture came back.On an unk date, after unk latency, pt had rash from the sulfamethoxazole/trimethoprim (dose, form, route and frequency: unk) and her local provider changes the antibiotic to cipro.Final culture showed it was contamination (contaminant staph epidermidis with 25000 to 50,000 colony forming units) versus actual infection.Pt had taken the antibiotics for the positive urinalysis she felt chills (onset: unk; latency: unk) and was not well but denied any urinary symptoms.Pt was concerned about the chills if there was something viral going on and would like to postpone surgery.On an unk date, the patient had swelling at the posterior aspect of right knee, was also popping of her knee, there was also a sense of knee locking such as at night when she extended knee to allow motion.On an unknow date, the patient complained of radiation of pain to dorsum of foot.Action taken: drug withdrawn nos for sulfamethoxazole/trimethoprim corrective trt: wheelchair and walker for could not walk; steroid injection, methylprednisolone (medrol) dose pack, walker, tramadol hydrochloride (tramadol), cyclobenzaprine hydrochloride (flexeril) for she had swelling/both of her knees are quite swollen; ice and leg brace, methylprednisolone, walker, tramadol hydrochloride, cyclobenzaprine hydrochloride for began to experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee; walker for knees getting tighter and tighter/everything feels too tight; methylprednisolone and use of walker for pseudo hypersensitivity response/pseudo hypersensitivity reaction to bilateral synvisc injection given to knees/sensitivity; walking, tramadol hydrochloride and cyclobenzaprine hydrochloride for flexing her right foot caused extreme pain in her knee; lisinopril for microalbuminuria; not reported for rest outcome: recovered/ resolved for she had swelling/both of her knees are quite swollen, experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee/posterior pain; unk for rest all events a global pharmaceutical technical complaint was initiated with gptc number: (b)(4) an investigation was initiated as a result of an unexpected increase in number of labelled 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 unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, presence of microbial contamination was also confirmed.Cause of these events was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness: disability for device malfunction could not walk, knees getting tighter and tighter/everything feels too tight, pseudo hypersensitivity response/pseudo hypersensitivity reaction to the bilateral synvisc injection given to knees/sensitivity, experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee, flexing her right foot caused extreme pain in her knee; required intervention and disability for she had swelling/both of her knees are quite swollen; medically significant for bladder tumor info recvd on (b)(6) 2018.The gptc number was added.Info recvd on (b)(6) 2018 from a physician.This case became medically confirmed.Additional events knees getting tighter and tighter/everything feels too tight, pseudo hypersensitivity response/pseudo hypersensitivity reaction to bilateral synvisc injection given to knees/sensitivity, flexing her right foot caused extreme pain in her knee, bladder tumor, discomfort, back of her right knee feels like going to have a charley horse any minute, rash, chills, microalbuminuria along with details were added.Event term she had swelling was updated to she had swelling/both of her knees are quite swollen and its corrective trt was added and its seriousness criteria was updated as disability and its outcome was updated as resolved.Event term experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising was updated to experience pain/pain became so excruciating/both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee, its seriousness criteria was updated as disability and outcome was updated as recovered/ resolved and corrective trts were added.Event term fluid was drawn off the right knee was updated to fluid was drawn off right knee/aspirated knee fluid/effusion aspirating 3 cc fluid/right knee effusion and leg did not pass the range of mobility test was updated to leg did not pass range of mobility test/lacks about 2 degrees of extension/cannot fully straighten out her knees getting tighter and tighter.Medical history, past drugs, concurrent conditions, family history and concomitant medications were added.Additional suspect product sulfamethoxazole/trimethoprim was added.Info recvd (b)(6) 2018 from physician.Medical history was updated.Lab data was added.Info rcvd on (b)(6) 2019 from lawyer.Event of sense of knee locking added.Verbatim updated for the event of experience pain/pain became so excruciating /both knees were in pain, right knee hurt more/pain was far beyond anything she could endure/right knee hurts more when exercising/soreness in knee/posterior pain and event of flexing her right foot caused extreme pain in her knee/radiation of pain to dorsum of foot.
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