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

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems Pain (1994); Skin Discoloration (2074); Swelling (2091); Toxicity (2333); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Numbness (2415); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 11/03/2017

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 15-dec-2017 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency patient is mobile but has difficulty standing, unable to bear weight, difficult to walk due to pain in hip/difficulty ambulating for long, left knee discoloration, has lost her quality of life, numbness going up into the left hip, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed, left knee swelling/swelling in the left knee/left knee was over double the size of the right knee, left knee pain and fluid was aspirated.Also device malfunction was identified for the reported lot number.No concomitant medication or concurrent condition was provided.The patient had past treatment with synvisc one.The medical history included injury to the left meniscus requiring surgery in the beginning of (b)(6) 2017.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (bilateral injection) (batch/ lot number: 7rsl021; expiry date: not reported).The patient did not do any heavy physical activity after injection.The day after the synvisc-one injection nurse recommended complete bed rest, which helped it improve a little bit.On an unknown date in (b)(6) 2017, the patient experienced excruciating pain going up and down her left leg and into the hip and left knee swelling which had not resolved.On an unknown date in (b)(6) 2017, the patient had swelling in the left knee and numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain the patient was able to ambulate for only short periods of time and was unable to perform her job and has lost her quality of life.Her right knee was fine.On an unknown date in (b)(6) 2017, it was difficult to walk due to pain in hip.The patient took naproxen, put a heating pad on her left hip and rested.On an unknown date in (b)(6) 2017, the pain was radiating from left ankle to left hip and the nurse recommended rest and to stay off her feet.The patient had a nappointment two weeks later, the patient underwent x-rays at that appointment and purchased a brace to assist her in bearing weight.The patient had swelling in the left knee and numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain.After synvisc-one left knee pain was 10 out of 10 still on (b)(6) 2017.The same day fluid was aspirated and was being cultured and wbc sample was sent for analysis.Mri was scheduled for (b)(6) 2017.It was reported that the patient was miserable and had thoughts of having her leg removed.There was no fever.Corrective treatment: not reported for device malfunction naproxen, put a heating pad on her left hip and rested, ice, brace, aspiration for rest of the events; outcome: not recovered for all the events.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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 23-dec-2017: this case concerns a patient who suffered from weight bearing difficulty, left knee swelling, left knee pain, difficulty in standing, difficulty in walking, skin discoloration, impaired quality of life, numbness and left leg pain after receiving synvisc one injection from the recalled lot.Temporal relationship can be established between the events and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, the pharmacological plausibility of the events to the product cannot be excluded.

Event Description

This unsolicited case from united states was received on 15-dec-2017 from a patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later after unknown latency patient is mobile but has difficulty standing, unable to bear weight, left knee discoloration, has lost her quality of life, numbness going up into the left hip/numbness in thigh area, fluid was aspirated; after 2 days had difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, pain in hip and ankle, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain above and around injection site, burning above and around injection; after 55 days had elevated crp.Also device malfunction was identified for the reported lot number.The patient had past treatment with synvisc one.The medical history included injury to the left meniscus requiring surgery in the beginning of (b)(6) 2017.Patient had arthritis, high blood pressure, sinusitis, bladder.Patient had allergy to drugs: cefalexin monohydrate (keflex), hydrocodone bitartrate/paracetamol (vicodin) and erythromycin (e-mycin) (slight case of hives).Concomitant medications include esomeprazole (nexium) for reflux; alprazolam (xanax) for insomnia and anxiety; naproxen sodium (aleve) and aleve on (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (bilateral injection) in knee (batch/lot number: 7rsl021; expiry date: not reported).The patient did not do any heavy physical activity after injection.The day after the synvisc-one injection nurse recommended complete bed rest, which helped it improve a little bit.Patient went to bed at night of (b)(6) 2017.On (b)(6) 2017, after 2 days of receiving synvisc one injection, patient woke up around 4 pm.There was a sharp pain in leg (left) and hip.It was reported that when patient got up, she could barely walk.Patient had severe swelling, pain, burning above and around injection site, pain in hip and ankle, numbness in thigh area.The patient experienced excruciating pain going up and down her left leg and into the hip and left knee swelling which had not resolved.It was reported that the patient had swelling in the left knee and numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain the patient was able to ambulate for only short periods of time and was unable to perform her job and has lost her quality of life.Her right knee was fine.It was difficult to walk due to pain in hip.The patient took naproxen, put a heating pad on her left hip and rested.It was reported that the pain was radiating from left ankle to left hip and the nurse recommended rest and to stay off her feet.The patient had an appointment two weeks later, the patient underwent x-rays at that appointment and purchased a brace to assist her in bearing weight.The patient had swelling in the left knee and numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain.On an unknown date in (b)(6) 2017, after unknown latency fluid was aspirated and was being cultured and wbc sample was sent for analysis.After synvisc-one left knee pain was 10 out of 10 still on (b)(6) 2017.On the same day, patient had knee joint effusion, which showed no signs of infection within joint.Patient had mri on (b)(6) 2017.It was reported that the patient was miserable and had thoughts of having her leg removed.There was no fever.On (b)(6) 2017, 55 days after receiving injection, patient had crp elevated (c-reactive protein) corrective treatment: naproxen, put a heating pad on her left hip and rested, ice, brace for patient is mobile but has difficulty standing, unable to bear weight, difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee discoloration, numbness going up into the left hip/numbness in thigh area, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain, fluid was aspirated; not reported for rest events outcome: unknown for elevated crp; not recovered for rest of the events 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction.Additional information was received on 10-jan-2018 from patient.Events of burning above and around injection, elevated crp, pain in hip and ankle were added along with its details.Concomitant medications and medical history was added.Verbatim was updated for the events of left knee pain to left knee pain/pain above and around injection site; left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site; excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed to excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left); numbness going up into the left hip to numbness going up into the left hip/numbness in thigh area; difficult to walk due to pain in hip/difficulty ambulating for long to difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk.Product start date was updated.Start date was updated for the events of difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee pain/pain above and around injection site and left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site.Clinical course updated.Text was amended accordingly pharmacovigilance comment: sanofi company comment follow up dated 10-jan-2018: follow up information did not change the previous case assessment.This case concerns a patient who suffered from weight bearing difficulty, left knee swelling, left knee pain, difficulty in standing, difficulty in walking, skin discoloration, impaired quality of life, numbness and left leg pain after receiving synvisc one injection from the recalled lot.Temporal relationship can be established between the events and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, the pharmacological plausibility of the events to the product cannot be excluded.

Event Description

Based on additional information received on (b)(6) 2018 from the physician, this case became medically confirmed.This unsolicited case from united states was received on (b)(6) 2017 from a patient.This case concerns a 54 year old female patient who received treatment with synvisc one and later after unknown latency patient is mobile but has difficulty standing, unable to bear weight, left knee discoloration, has lost her quality of life, numbness going up into the left hip/numbness in thigh area, fluid was aspirated; after 2 days had difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, pain in hip and ankle, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain above and around injection site, burning above and around injection; after 55 days had elevated crp, after unknown latency had joint pain, joint swelling, joint stiffness, had sores, environmental allergies, numbness going up into the left hip/numbness in thigh area/leg numbness, muscle pain, weight changes, rashes, and after 85 days had peripheral tear of medical meniscus, osteochondroma of left tibia and after 112 days had left knee pain (severe,sharp).Also device malfunction was identified for the reported lot number.The patient had past treatment with synvisc one.The medical history included psoriasis, injury to the left meniscus requiring surgery in the beginning of (b)(6) 2017, knee arthroscopy 2017, sinus surgery 2005, hysterectomy 2007, knee surgery 2008, bladder 2007, 2011.The patient's family history included father: arthritis, mother: cancer; grandparents: diagnosed with unknown disease; siblings: arthritis; children: diagnosed with unknown disease; maternal grand father: diagnosed with unknown disease; maternal grand mother: diagnosed with unknown disease.She had strong family history of hip arthritis.She had onset of pain in her late 20s and had injury in jun-2017 with a fall.She did have a scope on that knee in sep-2017.The patient had postoperative bleeding.She has had an mri that shows arthritis.The patient was not currently pregnant.The patient had no previous broken bones from a simple fall.Patient had arthritis, high blood pressure, sinusitis, bladder.Patient had allergy to drugs: cefalexin monohydrate (keflex), hydrocodone bitartrate/paracetamol (vicodin) and erythromycin (e-mycin) (slight case of hives).Concomitant medications include esomeprazole (nexium) for reflux; alprazolam (xanax) for insomnia and anxiety; naproxen sodium (aleve) and aleve.The patient did not smoke or used tobacco.The patient consumed alcohol socially (1 drink).The patient exercised regularly: 2-3 times per week but did not participate in recreational activities.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (bilateral injection) in knee (batch/lot number: 7rsl021; expiry date: not reported).The patient received bilateral injection without a lot of success.The synvisc-one that she got was reportedly part the bad back that did have some bacterial contamination although she has had no microscopic evidence of infection.The patient did not do any heavy physical activity after injection.The day after the synvisc-one injection nurse recommended complete bed rest, which helped it improve a little bit.Patient went to bed at night of 02-nov-2017.On 03-nov-2017, after 2 days of receiving synvisc one injection, patient woke up around 4 pm.There was a sharp pain in leg (left) and hip.It was reported that when patient got up, she could barely walk.Patient had severe swelling, pain, burning above and around injection site, pain in hip and ankle, numbness in thigh area.The patient experienced excruciating pain going up and down her left leg and into the hip and left knee swelling which had not resolved.It was reported that the patient had swelling in the left knee on an unknown date in nov-2017, the patient had numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain the patient was able to ambulate for only short periods of time and was unable to perform her job and has lost her quality of life.Her right knee was fine.It was difficult to walk due to pain in hip.The patient took naproxen, put a heating pad on her left hip and rested.It was reported that the pain was radiating from left ankle to left hip and the nurse recommended rest and to stay off her feet.The patient had an appointment two weeks later, the patient underwent x-rays at that appointment and purchased a brace to assist her in bearing weight.The patient had swelling in the left knee and numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain.On an unknown date in nov-2017, after unknown latency fluid was aspirated and was being cultured and wbc sample was sent for analysis.After synvisc-one left knee pain was 10 out of 10 still on 15-dec-2017.On the same day, patient had knee joint effusion, which showed no signs of infection within joint.Patient had mri on (b)(6) 2017.It was reported that the patient was miserable and had thoughts of having her leg removed.There was no fever.On (b)(6) 2017, 55 days after receiving injection, patient had crp elevated (c-reactive protein).On an unknown date, after unknown latency, the patient presented with severe left knee pain.It was reported that the injury was work related.Reportedly no pain was described as sharp, dull, burning.The injury was not a result of a motor vehicle accident: no.The patient was right handed.The patient has had physical or occupational therapy.The patient has had treatment elsewhere: pain scale: 7/10.The diagnostic testing for this problem included: x-ray, mr1.It was reported that the patient was seen in follow up for her left knee.The pain had gone from to a 7 following the injection and walking has gotten better as well.Her crp is 6.7 which is in the normal range which is encouraging.She wanted to try to lose weight and understands that her major issue is not meniscal pathology, but degenerative change present.Her left knee was tender anteriorly as well as medially, a little less tender than she was few weeks ago when we gave an injection.She described the pain as a bone pain running down the tibia towards the ankle.It was reported that for osteoarthritis of left knee, the patient would have to work on weight loss and she should have 4o pound weight lot and do physical therapy as well.The patient having psoriasis certainly could explain her elevated crps.It was reported that the patient's left knee was tender medially and had pain with range of motion.There was some soft tissue swelling and redness there well.The patient complained of pain with weight-bearing, pain on range of motion, also had numbness down into her foot which is probably not related to the knee.There might be more of a peripheral neuropathy.It was reported that x-rays of the knee taken including a flexion view really do not show much in the way of degenerative change, certainly nothing that would recommend surgery for.The patient had osteochondroma of the left tibia.There was also evidence of possible medial meniscus tear from the mri that she had done last year.On 25-jan-2018, 85 days after starting treatment the patient had peripheral tear of medial meniscus (current injury, left knee, initial encounter), osteochondroma of left tibia, osteoarthritis of left knee and leg numbness.The patient would be seen back in three months time to check her progress.The preventive medicinal care included: bmi care goal follow up plan bmt management, immunizations, screening / special tests and bone density test.This patient was seen in followup for her left knee.She did have repeat lab work where her crp has actually dropped from 8 to 7.4 from dec to feb.It was reported that the patient would have a rheumatologic profile drawn two years ago and said it came back normal.She has had to use a cane intermittently.Her sed rate was unremarkable.The patient was recommended that knee would be injected.She felt like she had a meniscal tear that might need attention.It was reported that based on what her x-rays, mr1 and workup the arthritis 1 was the bigger culprit going forward.It was reported that patient would like for her to repeat the crp to see which direction they were going and to do it at the same office because there had been some inconsistency and certainly no concern in regarding any persistent or lingering infection.The patient was told by physician to come in for her left knee.The patient would like to get cortisone injection next week as she was going out of town.On an unknown date, after unknown latency, the patient had fatigue, weight change, environmental allergies, back pain, joint pain/swelling, joint stiffness, muscle pain, gastric reflux, rash/sores, tingling numbness.The patient denied any hematology, urology, cardiology and respiratory pathology.The patient was followed for left foot plantar fasciitis.The patient was prescribed an exercise program.The patient did not have pain until recently.Her pain was the same as her last flare-up.She admitted not wearing supportive shoes as often as she should.It was reported that after discussing the risks and benefits of treatment the patient elected to have an injection of cortisone into their left foot.This was performed using sterile technique and the patient tolerated the procedure well.On an unknown date, the patient had left heel pain.She has had it for several months, it hasgotten to the point where it was very painful and significantly uncomfortable for her and ithurts all the time with every step.It was reported that the patient was having difficulty walking at work.She did have morning pain.The symptoms began spontaneously.The quality of pain was moderate.The injury was not work related and the pain was described as sharp dull.The injury was not a result of a motor vehicle accident.The patient did not have physicial or occupational therapy.The patient did not have treatment elsewhere.The pain scale was 6/10.Medications taken for this problem included anti inflammatory.On an unknown date, the patient had a moderate knee effusion is identified.No baker cyst was noted.Imaged extensor mechanism demonstrates no abnormality.A 0.6 cm near fluid signal intensity focus in the posterior aspect of the interspinous region of the proximal tibia probably represents a degenerative cyst.The finding was consistent with meniscal root avulsion tear of the poster or horn of the medial meniscus, peripheral extrusion of the body segment of the medial meniscus.The patient had compartmental arthritic changes, most pronounced in the medial compartment.The patient had prior medial meniscus.The patient had an apparent tear of the posterior horn of the medial meniscus at the meniscal root is mated.Postsurgical change is a less likely consideration.The body segment of the medial meniscus is peripherally extruded.The lateral meniscus demonstrates no evidence of tear.Reportedly the anterior and posterior cruciate ligaments appeared intact.The medial collateral ligament appears intact.The lateral collateral ligament complex demonstrates no abnormality.The patellar articular cartilage demonstrates mild diffuse thinning land irregularity, predominantly involving the lateral facet.The medial comprtment articular cartilage demonstrates diffuse thinning and irregularity.The lateral compartment articular cartilage demonstrated thinning and irregularity.Corrective treatment: anti inflammatory drug (unspecified), bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depomedrol), dexamethasone (decadron) for joint swelling, joint stiffness, joint pain, sores; celecoxib, bupivacaine hydrochloride (marcaine) at a dose of 4 mg, methylprednisolone acetate (depomedrol), dexamethasone (decadron) for peripheral tear of medical meniscus; anti inflammatory drug (unspecified) for muscle pain, tingling, rashes; naproxen, put a heating pad on her left hip and rested, ice, brace for patient is mobile but has difficulty standing, unable to bear weight, difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee discoloration, numbness going up into the left hip/numbness in thigh area, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain, fluid was aspirated; celocoxlb,physical/ occupational therapy,anti inflammatory drug (unspecified), bupivacaine hydrochloride (marcaine),, methylprednisolone acetate (depomedrol),, dexamethasone (decadron) for left knee pain (severe,sharp); not reported for rest events outcome: unknown for rashes, left knee pain (severe,sharp), weight changes, sores, tingling, muscle pain, osteochondroma of left tibia, environmental allergies, elevated crp, joint swelling, joint pain, joint stiffness, peripheral tear of medical meniscus; not recovered for rest of the events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51392 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for left knee pain (severe,sharp), peripheral tear of medical meniscus, joint swelling, joint stiffness, joint pain, device malfunction.Additional information was received on 10-jan-2018 from patient.Events of burning above and around injection, elevated crp, pain in hip and ankle were added along with its details.Concomitant medications and medical history was added.Verbatim was updated for the events of left knee pain to left knee pain/pain above and around injection site; left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site; excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed to excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left); numbness going up into the left hip to numbness going up into the left hip/numbness in thigh area; difficult to walk due to pain in hip/difficulty ambulating for long to difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk.Product start date was updated.Start date was updated for the events of difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee pain/pain above and around injection site and left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site.Clinical course updated.Text was amended accordingly follow up was received on 18-jan-2018.Global ptc number was added.Additional information was received on 04-may-2018 from the physician.This case became medically confirmed.The additional events of left knee pain (severe,sharp), joint pain, joint swelling, joint stiffness, had sores, environmental allergies, numbness going up into the left hip/numbness in thigh area/leg numbness, muscle pain, weight changes, rashes, peripheral tear of medical meniscus and osteochondroma of left tibia were added with details.The seriousness criteria of the event of device malfunction was updated to required intervention.The patient's medical history and family history was added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 04-may-2018: follow up information did not change the previous case assessment.This case concerns a patient who suffered from weight bearing difficulty, left knee swelling, left knee pain, difficulty in standing, difficulty in walking, skin discoloration, impaired quality of life, left knee pain, joint swelling, joint stiffness, joint pain, meniscus tear of knee, pain , numbness and left leg pain after receiving synvisc one injection from the recalled lot.Temporal relationship can be established between few events and the suspect product and and cannot be established with left knee pain, joint swelling, joint stiffness, joint pain, meniscus tear of knee, pain based on the available information based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, the pharmacological plausibility of the events to the product cannot be excluded.

Event Description

Device malfunction [device malfunction].Mild cellulitis anterior knee [cellulitis knee].Patient is mobile but has difficulty standing [difficulty in standing].Unable to bear weight/ cant put weight on the leg [weight bearing difficulty].Difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently/ issues walking due to swelling [unable to walk].Has lost her quality of life [impaired quality of life].Fluid was aspirated/ knee aspiration [effusion (l) knee].Left knee pain (severe,sharp) [knee pain].Joint swelling/ swelling has increased [joint swelling].Joint stiffness [joint stiffness].Pain in hip and ankle/joint pain [joint pain].Peripheral tear of medical meniscus/ root avulsion tear of medial meniscus [tear of medial cartilage or meniscus of knee, current].Sores [pain].Enviromental allergies [environmental allergy].Osteochondroma of left tibia [osteochondroma].Tingling [tingling].Muscle pain [muscle pain].Weight changes [weight abnormal].Left knee discoloration [skin discoloration].Numbness going up into the left hip/numbness in thigh area/leg numbness/ very little feeling in left thigh/ numb [numbness].Excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left) [unilateral leg pain] ([irradiating pain]) elevated crp/ slightly elevated or high normal crp [c-reactive protein increased].Left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site [injection site swelling] left knee pain/pain above and around injection site [injection site pain] burning above and around injection/ burning in the knee area [injection site burning].Rashes [rash].Case narrative: based on additional information received on 04-may-2018 from the physician, this case became medically confirmed.This unsolicited case from united states was received on 15-dec-2017 from a patient.This case concerns a 55 year old female patient who received treatment with synvisc one and later after unknown latency patient is mobile but has difficulty standing, unable to bear weight/ cant put weight on the leg (latency: 2 days), left knee discoloration, mild cellulitis anterior knee, has lost her quality of life, numbness going up into the left hip/numbness in thigh area, fluid was aspirated; after 2 days had difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently/ issues walking due to swelling, pain in hip and ankle, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain above and around injection site, burning above and around injection/ burning in the knee area; after 55 days had elevated crp/ slightly elevated or high normal crp, after unknown latency had joint pain, joint swelling/ swelling has increased, joint stiffness, had sores, environmental allergies numbness going up into the left hip/numbness in thigh area/leg numbness/ very little feeling in left thigh/ numb, muscle pain, weight changes, rashes, and after 85 days had peripheral tear of medical meniscus, osteochondroma of left tibia and after 112 days had left knee pain (severe,sharp).Also device malfunction was identified for the reported lot number.Patient had past treatment with synvisc one.The medical history included psoriasis, injury to the left meniscus requiring surgery in the beginning of (b)(6) 2017, knee arthroscopy 2017, sinus surgery 2005, hysterectomy 2007, knee surgery 2008, bladder 2007, 2011; trochanteric bursitis, sinusitis, gerd (acid reflux).Patient's family history included father: arthritis, copd, mother: cancer, hypertensive disorder; grandparents: diagnosed with unknown disease; sister, brother: arthritis; children: diagnosed with unknown disease; maternal grand father: diagnosed with unknown disease; maternal grand mother: diagnosed with unknown disease.She had strong family history of hip arthritis.She had onset of pain in her late 20s and had injury in (b)(6) 2017 with a fall.She did have a scope on that knee in (b)(6) 2017.Patient had postoperative bleeding.She has had an mri that shows arthritis.Patient was not currently pregnant.Patient had no previous broken bones from a simple fall.Patient had arthritis, high blood pressure, sinusitis, bladder.Patient had allergy to drugs: cefalexin monohydrate (keflex), hydrocodone bitartrate/paracetamol (vicodin) and erythromycin (e-mycin) (slight case of hives).Concomitant medications include esomeprazole (nexium) for reflux; alprazolam (xanax) for insomnia and anxiety; naproxen sodium (aleve) and aleve, amoxicillin, clobetasol topical foam, topical cream, scalp solution, methylprednisolone acetate (depo-medrol), ergocalciferol (vitamin d2), lidocaine, bupivacaine hydrochloride (marcaine), oxycodone hydrochloride/paracetamol (percocet), methylprednisolone (medrol (pak)), sulfamethoxazole/trimethoprim.Patient did not smoke or used tobacco.Patient consumed alcohol socially (1 drink).Patient exercised regularly: 2-3 times per week but did not participate in recreational activities.On (b)(6) 2017, patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (bilateral injection) in knee (batch/lot number: 7rsl021; expiry date: may-2020).Patient received bilateral injection without a lot of success.The synvisc-one that she got was reportedly part the bad back that did have some bacterial contamination although she has had no microscopic evidence of infection.Patient did not do any heavy physical activity after injection.The day after the synvisc-one injection nurse recommended complete bed rest, which helped it improve a little bit.Patient went to bed at night of (b)(6) 2017.On (b)(6) 2017, after 2 days of receiving synvisc one injection, patient woke up around 4 pm.There was a sharp pain in leg (left) and hip.It was reported that when patient got up, she could barely walk and unable to bear weight.Patient had severe swelling, pain, burning above and around injection site, pain in hip and ankle, numbness in thigh area.Patient experienced excruciating pain going up and down her left leg and into the hip and left knee swelling which had not resolved.It was reported that patient had swelling in the left knee.On(b)(6) 2017, the x-ray of knee (bilateral) showed evidence of osteoarticular abnormality but no fracture and no dislocation.Medial joint space narrowing and patellofemoral joint space narrowing.On an unknown date in (b)(6) 2017, patient had numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain patient was able to ambulate for only short periods of time and was unable to perform her job and has lost her quality of life.Her right knee was fine.It was difficult to walk due to pain in hip.Patient took naproxen, put a heating pad on her left hip and rested.It was reported that the pain was radiating from left ankle to left hip and the nurse recommended rest and to stay off her feet.Patient had an appointment two weeks later, patient underwent x-rays at that appointment and purchased a brace to assist her in bearing weight.Patient had swelling in the left knee and numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain.On an unknown date in (b)(6) 2017, after unknown latency fluid was aspirated and was being cultured and wbc sample was sent for analysis.After synvisc-one left knee pain was 10 out of 10 still on (b)(6) 2017.On the same day, patient had knee joint effusion, which showed no signs of infection within joint.Patient had mri on (b)(6) 2017.It was reported that patient was miserable and had thoughts of having her leg removed.There was no fever.On (b)(6) 2017, 55 days after receiving injection, patient had crp elevated (c-reactive protein).On an unknown date, after unknown latency, patient presented with severe left knee pain.It was reported that the injury was work related.Reportedly no pain was described as sharp, dull, burning.The injury was not a result of a motor vehicle accident: no.Patient was right handed.Patient has had physical or occupational therapy.Patient has had treatment elsewhere: pain scale: 7/10.The diagnostic testing for this problem included: x-ray, mr1.It was reported that patient was seen in follow up for her left knee.The pain had gone from to a 7 following the injection and walking has gotten better as well.Her crp is 6.7 which is in the normal range which is encouraging.She wanted to try to lose weight and understands that her major issue is not meniscal pathology, but degenerative change present.Her left knee was tender anteriorly as well as medially, a little less tender than she was few weeks ago when we gave an injection.She described the pain as a bone pain running down the tibia towards the ankle.It was reported that for osteoarthritis of left knee, patient would have to work on weight loss and she should have 4o pound weight lot and do physical therapy as well.Patient having psoriasis certainly could explain her elevated crps.It was reported that patient's left knee was tender medially and had pain with range of motion.There was some soft tissue swelling and redness there well.Patient complained of pain with weight-bearing, pain on range of motion, also had numbness down into her foot which is probably not related to the knee.There might be more of a peripheral neuropathy.It was reported that x-rays of the knee taken including a flexion view really do not show much in the way of degenerative change, certainly nothing that would recommend surgery for.Patient had osteochondroma of the left tibia.There was also evidence of possible medial meniscus tear from the mri that she had done last year.On (b)(6) 2018, 85 days after starting treatment patient had peripheral tear of medial meniscus (current injury, left knee, initial encounter), osteochondroma of left tibia, osteoarthritis of left knee and leg numbness.Patient would be seen back in three months time to check her progress.The preventive medicinal care included: bmi care goal follow up plan bmt management, immunizations, screening / special tests and bone density test.This patient was seen in followup for her left knee.She did have repeat lab work where her crp has actually dropped from 8 to 7.4 from dec to feb.It was reported that patient would have a rheumatologic profile drawn two years ago and said it came back normal.She has had to use a cane intermittently.Her sed rate was unremarkable.Patient was recommended that knee would be injected.She felt like she had a meniscal tear that might need attention.It was reported that based on what her x-rays, mr1 and workup the arthritis 1 was the bigger culprit going forward.It was reported that patient would like for her to repeat the crp to see which direction they were going and to do it at the same office because there had been some inconsistency and certainly no concern in regarding any persistent or lingering infection.Patient was told by physician to come in for her left knee.Patient would like to get cortisone injection next week as she was going out of town.On an unknown date, after unknown latency, patient had fatigue, weight change, environmental allergies, back pain, joint pain/swelling, joint stiffness, muscle pain, gastric reflux, rash/sores, tingling numbness.Patient denied any hematology, urology, cardiology and respiratory pathology.Patient was followed for left foot plantar fasciitis.Patient was prescribed an exercise program.Patient did not have pain until recently.Her pain was the same as her last flare-up.She admitted not wearing supportive shoes as often as she should.It was reported that after discussing the risks and benefits of treatment patient elected to have an injection of cortisone into their left foot.This was performed using sterile technique and patient tolerated the procedure well.On an unknown date, patient had left heel pain.She has had it for several months, it hasgotten to the point where it was very painful and significantly uncomfortable for her and ithurts all the time with every step.It was reported that patient was having difficulty walking at work.She did have morning pain.The symptoms began spontaneously.The quality of pain was moderate.The injury was not work related and the pain was described as sharp dull.The injury was not a result of a motor vehicle accident.Patient did not have physicial or occupational therapy.Patient did not have treatment elsewhere.The pain scale was 6/10.Medications taken for this problem included anti inflammatory.On an unknown date, patient had a moderate knee effusion is identified.No baker cyst was noted.Imaged extensor mechanism demonstrates no abnormality.A 0.6 cm near fluid signal intensity focus in the posterior aspect of the interspinous region of the proximal tibia probably represents a degenerative cyst.The finding was consistent with meniscal root avulsion tear of the poster or horn of the medial meniscus, peripheral extrusion of the body segment of the medial meniscus.Patient had compartmental arthritic changes, most pronounced in the medial compartment.Patient had prior medial meniscus.Patient had an apparent tear of the posterior horn of the medial meniscus at the meniscal root is mated.Postsurgical change is a less likely consideration.The body segment of the medial meniscus is peripherally extruded.The lateral meniscus demonstrates no evidence of tear.Reportedly the anterior and posterior cruciate ligaments appeared intact.The medial collateral ligament appears intact.The lateral collateral ligament complex demonstrates no abnormality.The patellar articular cartilage demonstrates mild diffuse thinning land irregularity, predominantly involving the lateral facet.The medial comprtment articular cartilage demonstrates diffuse thinning and irregularity.The lateral compartment articular cartilage demonstrated thinning and irregularity.On an unknown date after unknown latency, the sulfamethoxazole/trimethoprim (bactrim) for some mild cellulitis.Her main concern is the continued bleeding she had been having from the medial portal site.The portal site was not currently draining.There was a tiny spot of blood on a band aid that was placed over the site.There was no sign of infection.She was also complained of persistent pain in the knee.The medial portal was steri-stripped and the knee wrapped with an ace.Pt was reassured that the bleeding looks like it had stopped, continued wrapping the knee for several more days, the sulfamethoxazole/trimethoprim (bactrim) as prescribed.Corrective treatment: anti inflammatory drug (unspecified), bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depomedrol), dexamethasone (decadron) for joint swelling/ swelling has increased, joint stiffness, joint pain, sores; celecoxib, bupivacaine hydrochloride (marcaine) at a dose of 4 mg, methylprednisolone acetate (depomedrol), dexamethasone (decadron) for peripheral tear of medical meniscus; anti inflammatory drug (unspecified) for muscle pain, tingling, rashes; naproxen (naprosyn), put a heating pad on her left hip and rested, ice, brace for patient is mobile but has difficulty standing, unable to bear weight, difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee discoloration, numbness going up into the left hip/numbness in thigh area, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain, fluid was aspirated; celocoxlb,physical/ occupational therapy,anti inflammatory drug (unspecified), bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depomedrol), dexamethasone (decadron) for left knee pain (severe,sharp); not reported for rest events outcome: unknown for mild cellulitis anterior knee, rashes, weight changes, sores, tingling, muscle pain, osteochondroma of left tibia, environmental allergies, elevated crp/ slightly elevated or high normal crp, joint swelling/ swelling has increased, joint pain, joint stiffness, peripheral tear of medical meniscus; celocoxlb,physical/ occupational therapy,anti inflammatory drug (unspecified),marcaine, depomedrol, decadron, celecoxib (celebrex) for left knee pain (severe,sharp), not recovered for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for left knee pain (severe,sharp), peripheral tear of medical meniscus, joint swelling/ swelling has increased, joint stiffness, joint pain, device malfunction.Additional information was received on 10-jan-2018 from patient.Events of burning above and around injection, elevated crp, pain in hip and ankle were added along with its details.Concomitant medications and medical history was added.Verbatim updated for the events of left knee pain to left knee pain/pain above and around injection site; left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site; excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed to excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left); numbness going up into the left hip to numbness going up into the left hip/numbness in thigh area; difficult to walk due to pain in hip/difficulty ambulating for long to difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk.Product start date updated.Start date updated for the events of difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee pain/pain above and around injection site and left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site.Clinical course updated.Text was amended accordingly follow up was received on 18-jan-2018.Global ptc number was added.Additional information was received on 04-may-2018 from the physician.This case became medically confirmed.The additional events of left knee pain (severe,sharp), joint pain, joint swelling, joint stiffness, had sores, environmental allergies, numbness going up into the left hip/numbness in thigh area/leg numbness, muscle pain, weight changes, rashes, peripheral tear of medical meniscus and osteochondroma of left tibia were added with details.The seriousness criteria of the event of device malfunction updated to required intervention.Patient's medical history and family history was added.Clinical course updated.Text was amended accordingly.Additional information was received on 09-may-2018 from physician.Expiration date of synvisc one.Concomitant medications were added.Event mild cellulitis anterior knee was added.Verbatim of event burning above and around injection updated to burning above and around injection/ burning in the knee area; unable to bear weight updated to unable to bear weight/ cant put weight on the leg; joint swelling updated to joint swelling/ swelling has increased; numbness going up into the left hip/numbness in thigh area/leg numbness updated to numbness going up into the left hip/numbness in thigh area/leg numbness/ very little feeling in left thigh/ numb; difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently updated to difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently/ issues walking due to swelling; elevated crp updated to elevated crp/ slightly elevated or high normal crp.Clinical course updated.Text was amended accordingly.

Event Description

Device malfunction [device malfunction].Mild cellulitis anterior knee [cellulitis knee].Patient is mobile but has difficulty standing [difficulty in standing].Unable to bear weight/ cant put weight on the leg~ [weight bearing difficulty].Difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently/ issues walking due to swelling [unable to walk].Has lost her quality of life [impaired quality of life].Fluid was aspirated/ knee aspiration [effusion (l) knee].Left knee pain (severe,sharp) [knee pain].Joint swelling/ swelling has increased [joint swelling].Joint stiffness [joint stiffness].Pain in hip and ankle/joint pain/left knee that is painful [joint pain].Peripheral tear of medical meniscus/ root avulsion tear of medial meniscus [tear of medial cartilage or meniscus of knee, current].Sores [pain].Environmental allergies [environmental allergy].Osteochondroma of left tibia [osteochondroma].Tingling [tingling].Muscle pain [muscle pain].Weight changes [weight abnormal].Left knee discoloration [skin discoloration].Numbness going up into the left hip/numbness in thigh area/leg numbness/ very little feeling in left thigh/ numb [numbness].Excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left) [unilateral leg pain] ([irradiating pain]).Elevated crp/ slightly elevated or high normal crp [c-reactive protein increased].Left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site~ [injection site swelling].Left knee pain/pain~ above and around injection site~ [injection site pain].Burning above and around injection/ burning in the knee area [injection site burning].Rashes [rash].Case narrative: based on additional information received on 04-may-2018 from the physician, this case became medically confirmed.This unsolicited case from united states was received on 15-dec-2017 from a patient.This case concerns a 55 year old female patient who received treatment with synvisc one and later after unknown latency patient is mobile but has difficulty standing, unable to bear weight/ cant put weight on the leg (latency: 2 days), left knee discoloration, mild cellulitis anterior knee, has lost her quality of life, numbness going up into the left hip/numbness in thigh area, fluid was aspirated; after 2 days had difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently/ issues walking due to swelling, pain in hip/ left knee that is painful and ankle, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain above and around injection site, burning above and around injection/ burning in the knee area; after 55 days had elevated crp/ slightly elevated or high normal crp, after unknown latency had joint pain, joint swelling/ swelling has increased, joint stiffness, had sores, environmental allergies numbness going up into the left hip/numbness in thigh area/leg numbness/ very little feeling in left thigh/ numb, muscle pain, weight changes, rashes, and after 85 days had peripheral tear of medical meniscus, osteochondroma of left tibia and after 112 days had left knee pain (severe,sharp).Also device malfunction was identified for the reported lot number.Patient had past treatment with synvisc one.The medical history included psoriasis, injury to the left meniscus requiring surgery in the beginning of (b)(6) 2017, knee arthroscopy 2017, sinus surgery 2005, hysterectomy 2007, knee surgery 2008, bladder 2007, 2011; trochanteric bursitis, sinusitis, gerd (acid reflux).Patient's family history included father: arthritis, copd, mother: cancer, hypertensive disorder; grandparents: diagnosed with unknown disease; sister, brother: arthritis; children: diagnosed with unknown disease; maternal grand father: diagnosed with unknown disease; maternal grand mother: diagnosed with unknown disease.She had strong family history of hip arthritis.She had onset of pain in her late 20's and had injury in (b)(6) 2017 with a fall.She did have a scope on that knee in (b)(6) 2017.Patient had postoperative bleeding.She has had an mri that shows arthritis.Patient was not currently pregnant.Patient had no previous broken bones from a simple fall.Patient had arthritis, high blood pressure, sinusitis, bladder.Patient had allergy to drugs: cefalexin monohydrate (keflex), hydrocodone bitartrate/paracetamol (vicodin) and erythromycin (e-mycin) (slight case of hives).Concomitant medications include esomeprazole (nexium) for reflux; alprazolam (xanax) for insomnia and anxiety; naproxen sodium (aleve) and aleve, amoxicillin, clobetasol topical foam, topical cream, scalp solution, methylprednisolone acetate (depo-medrol), ergocalciferol (vitamin d2), lidocaine, bupivacaine hydrochloride (marcaine), oxycodone hydrochloride/paracetamol (percocet), methylprednisolone (medrol (pak)), sulfamethoxazole/trimethoprim.Patient did not smoke or used tobacco.Patient consumed alcohol socially (1 drink).Patient exercised regularly: 2-3 times per week but did not participate in recreational activities.On (b)(60 2017, patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (bilateral injection) in knee (batch/lot number: 7rsl021; expiry date: may-2020).Patient received bilateral injection without a lot of success.The synvisc-one that she got was reportedly part the bad back that did have some bacterial contamination although she has had no microscopic evidence of infection.Patient did not do any heavy physical activity after injection.The day after the synvisc-one injection nurse recommended complete bed rest, which helped it improve a little bit.Patient went to bed at night of (b)(6) 2017.On (b)(6) 2017, after 2 days of receiving synvisc one injection, patient woke up around 4 pm.There was a sharp pain in leg (left) and hip.It was reported that when patient got up, she could barely walk and unable to bear weight.Patient had severe swelling, pain, burning above and around injection site, pain in hip and ankle, numbness in thigh area.Patient experienced excruciating pain going up and down her left leg and into the hip and left knee swelling which had not resolved.It was reported that patient had swelling in the left knee.On (b)(6) 2017, the x-ray of knee (bilateral) showed evidence of osteoarticular abnormality but no fracture and no dislocation.Medial joint space narrowing and patellofemoral joint space narrowing.On an unknown date in (b)(6) 2017, patient had numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain patient was able to ambulate for only short periods of time and was unable to perform her job and has lost her quality of life.Her right knee was fine.It was difficult to walk due to pain in hip.Patient took naproxen, put a heating pad on her left hip and rested.It was reported that the pain was radiating from left ankle to left hip and the nurse recommended rest and to stay off her feet.Patient had an appointment two weeks later, patient underwent x-rays at that appointment and purchased a brace to assist her in bearing weight.Patient had swelling in the left knee and numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain.On an unknown date in (b)(6) 2017, after unknown latency fluid was aspirated and was being cultured and wbc sample was sent for analysis.After synvisc-one left knee pain was 10 out of 10 still on (b)(6) 2017.On the same day, patient had knee joint effusion, which showed no signs of infection within joint.Patient had mri on (b)(6) 2017.It was reported that patient was miserable and had thoughts of having her leg removed.There was no fever.On (b)(6) 2017, 55 days after receiving injection, patient had crp elevated (c-reactive protein).On an unknown date, after unknown latency, patient presented with severe left knee pain.It was reported that the injury was work related.Reportedly no pain was described as sharp, dull, burning.The injury was not a result of a motor vehicle accident: no.Patient was right handed.Patient has had physical or occupational therapy.Patient has had treatment elsewhere: pain scale: 7/10.The diagnostic testing for this problem included: x-ray, mr1.It was reported that patient was seen in follow up for her left knee.The pain had gone from to a 7 following the injection and walking has gotten better as well.Her crp is 6.7 which is in the normal range which is encouraging.She wanted to try to lose weight and understands that her major issue is not meniscal pathology, but degenerative change present.Her left knee was tender anteriorly as well as medially, a little less tender than she was few weeks ago when we gave an injection.She described the pain as a bone pain running down the tibia towards the ankle.It was reported that for osteoarthritis of left knee, patient would have to work on weight loss and she should have 40 pound weight lot and do physical therapy as well.Patient having psoriasis certainly could explain her elevated crps.It was reported that patient's left knee was tender medially and had pain with range of motion.There was some soft tissue swelling and redness there well.Patient complained of pain with weight-bearing, pain on range of motion, also had numbness down into her foot which is probably not related to the knee.There might be more of a peripheral neuropathy.It was reported that x-rays of the knee taken including a flexion view really do not show much in the way of degenerative change, certainly nothing that would recommend surgery for.Patient had osteochondroma of the left tibia.There was also evidence of possible medial meniscus tear from the mri that she had done last year.On (b)(6) 2018, 85 days after starting treatment patient had peripheral tear of medial meniscus (current injury, left knee, initial encounter), osteochondroma of left tibia, osteoarthritis of left knee and leg numbness.Patient would be seen back in three months time to check her progress.The preventive medicinal care included: bmi care goal follow up plan bmt management, immunizations, screening / special tests and bone density test.This patient was seen in followup for her left knee.She did have repeat lab work where her crp has actually dropped from 8 to 7.4 from (b)(6).It was reported that patient would have a rheumatologic profile drawn two years ago and said it came back normal.She has had to use a cane intermittently.Her sed rate was unremarkable.Patient was recommended that knee would be injected.She felt like she had a meniscal tear that might need attention.It was reported that based on what her x-rays, mr1 and workup the arthritis 1 was the bigger culprit going forward.It was reported that patient would like for her to repeat the crp to see which direction they were going and to do it at the same office because there had been some inconsistency and certainly no concern in regarding any persistent or lingering infection.Patient was told by physician to come in for her left knee.Patient would like to get cortisone injection next week as she was going out of town.On an unknown date, after unknown latency, patient had fatigue, weight change, environmental allergies, back pain, joint pain/swelling, joint stiffness, muscle pain, gastric reflux, rash/sores, tingling numbness.Patient denied any hematology, urology, cardiology and respiratory pathology.Patient was followed for left foot plantar fasciitis.Patient was prescribed an exercise program.Patient did not have pain until recently.Her pain was the same as her last flare-up.She admitted not wearing supportive shoes as often as she should.It was reported that after discussing the risks and benefits of treatment patient elected to have an injection of cortisone into their left foot.This was performed using sterile technique and patient tolerated the procedure well.On an unknown date, patient had left heel pain.She has had it for several months, it has gotten to the point where it was very painful and significantly uncomfortable for her and it hurts all the time with every step.It was reported that patient was having difficulty walking at work.She did have morning pain.The symptoms began spontaneously.The quality of pain was moderate.The injury was not work related and the pain was described as sharp dull.The injury was not a result of a motor vehicle accident.Patient did not have physical or occupational therapy.Patient did not have treatment elsewhere.The pain scale was 6/10.Medications taken for this problem included anti inflammatory.On an unknown date, patient had a moderate knee effusion is identified.No baker cyst was noted.Imaged extensor mechanism demonstrates no abnormality.A 0.6 cm near fluid signal intensity focus in the posterior aspect of the interspinous region of the proximal tibia probably represents a degenerative cyst.The finding was consistent with meniscal root avulsion tear of the poster or horn of the medial meniscus, peripheral extrusion of the body segment of the medial meniscus.Patient had compartmental arthritic changes, most pronounced in the medial compartment.Patient had prior medial meniscus.Patient had an apparent tear of the posterior horn of the medial meniscus at the meniscal root is mated.Postsurgical change is a less likely consideration.The body segment of the medial meniscus is peripherally extruded.The lateral meniscus demonstrates no evidence of tear.Reportedly the anterior and posterior cruciate ligaments appeared intact.The medial collateral ligament appears intact.The lateral collateral ligament complex demonstrates no abnormality.The patellar articular cartilage demonstrates mild diffuse thinning land irregularity, predominantly involving the lateral facet.The medial compartment articular cartilage demonstrates diffuse thinning and irregularity.The lateral compartment articular cartilage demonstrated thinning and irregularity.On an unknown date after unknown latency, the sulfamethoxazole/trimethoprim (bactrim) for some mild cellulitis.Her main concern is the continued bleeding she had been having from the medial portal site.The portal site was not currently draining.There was a tiny spot of blood on a band aid that was placed over the site.There was no sign of infection.She was also complained of persistent pain in the knee.The medial portal was steri-stripped and the knee wrapped with an ace.Pt was reassured that the bleeding looks like it had stopped, continued wrapping the knee for several more days, the sulfamethoxazole/trimethoprim (bactrim) as prescribed.On (b)(6) 2018 patient reported to the clinic stating that her left knee is painful and has an altered gait.The patient stated that she does not want an injection but would like to discuss an oral steroid.The patient was given a medrol-dosepak.Corrective treatment: anti inflammatory drug (unspecified), bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depomedrol), dexamethasone (decadron) for joint swelling/ swelling has increased, joint stiffness, joint pain, sores; celecoxib, bupivacaine hydrochloride (marcaine) at a dose of 4 mg, methylprednisolone acetate (depomedrol), dexamethasone (decadron) for peripheral tear of medical meniscus; anti inflammatory drug (unspecified) for muscle pain, tingling, rashes; naproxen (naprosyn), put a heating pad on her left hip and rested, ice, brace for patient is mobile but has difficulty standing, unable to bear weight, difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee discoloration, numbness going up into the left hip/numbness in thigh area, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain, fluid was aspirated; celocoxlb,physical/ occupational therapy,anti inflammatory drug (unspecified), bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depomedrol), dexamethasone (decadron) for left knee pain (severe,sharp); not reported for rest events.Outcome: unknown for mild cellulitis anterior knee, rashes, weight changes, sores, tingling, muscle pain, osteochondroma of left tibia, environmental allergies, elevated crp/ slightly elevated or high normal crp, joint swelling/ swelling has increased, joint pain, joint stiffness, peripheral tear of medical meniscus; celocoxlb,physical/ occupational therapy,anti inflammatory drug (unspecified),marcaine, depomedrol, decadron, celecoxib (celebrex) for left knee pain (severe,sharp), not recovered for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with (b)(4).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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for left knee pain (severe,sharp), peripheral tear of medical meniscus, joint swelling/ swelling has increased, joint stiffness, joint pain, device malfunction.Additional information was received on 10-jan-2018 from patient.Events of burning above and around injection, elevated crp, pain in hip and ankle were added along with its details.Concomitant medications and medical history was added.Verbatim updated for the events of left knee pain to left knee pain/pain above and around injection site; left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site; excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed to excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left); numbness going up into the left hip to numbness going up into the left hip/numbness in thigh area; difficult to walk due to pain in hip/difficulty ambulating for long to difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk.Product start date updated.Start date updated for the events of difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee pain/pain above and around injection site and left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site.Clinical course updated.Text was amended accordingly.Follow up was received on 18-jan-2018.Global ptc number was added.Additional information was received on 04-may-2018 from the physician.This case became medically confirmed.The additional events of left knee pain (severe,sharp), joint pain, joint swelling, joint stiffness, had sores, environmental allergies, numbness going up into the left hip/numbness in thigh area/leg numbness, muscle pain, weight changes, rashes, peripheral tear of medical meniscus and osteochondroma of left tibia were added with details.The seriousness criteria of the event of device malfunction updated to required intervention.Patient's medical history and family history was added.Clinical course updated.Text was amended accordingly.Additional information was received on 09-may-2018 from physician.Expiration date of synvisc one.Concomitant medications were added.Event mild cellulitis anterior knee was added.Verbatim of event burning above and around injection updated to burning above and around injection/ burning in the knee area; unable to bear weight updated to unable to bear weight/ cant put weight on the leg; joint swelling updated to joint swelling/ swelling has increased; numbness going up into the left hip/numbness in thigh area/leg numbness updated to numbness going up into the left hip/numbness in thigh area/leg numbness/ very little feeling in left thigh/ numb; difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently updated to difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently/ issues walking due to swelling; elevated crp updated to elevated crp/ slightly elevated or high normal crp.Clinical course updated.Text was amended accordingly.Additional information received on 21-aug-2018 from health care professional.Event verbatim updated for pain in hip and ankle/joint pain to pain in hip and ankle/joint pain/left knee that is painful and event details added.Clinical course updated.Text amended accordingly.

Event Description

Device malfunction [device malfunction] mild cellulitis anterior knee [cellulitis knee] patient is mobile but has difficulty standing [difficulty in standing] unable to bear weight/ cant put weight on the leg~ [weight bearing difficulty] difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently/ issues walking due to swelling [unable to walk] has lost her quality of life [impaired quality of life] fluid was aspirated/ knee aspiration [effusion (l) knee] left knee pain (severe, sharp) [knee pain] joint swelling/ swelling has increased [joint swelling] joint stiffness [joint stiffness] pain in hip and ankle/joint pain/left knee that is painful [joint pain] peripheral tear of medical meniscus/ root avulsion tear of medial meniscus [tear of medial cartilage or meniscus of knee, current] sores [pain] environmental allergies [environmental allergy] osteochondroma of left tibia [osteochondroma] tingling [tingling] muscle pain [muscle pain] weight changes [weight abnormal] left knee discoloration [skin discoloration] numbness going up into the left hip/numbness in thigh area/leg numbness/ very little feeling in left thigh/ numb [numbness] excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left) [unilateral leg pain] ([irradiating pain]) elevated crp/ slightly elevated or high normal crp [c-reactive protein increased] left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site~ [injection site swelling] left knee pain/pain~ above and around injection site~ [injection site pain] burning above and around injection/ burning in the knee area [injection site burning] rashes [rash].Case narrative: based on additional information received on 04-may-2018 from the physician, this case became medically confirmed.This unsolicited case from united states was received on 15-dec-2017 from a patient.This case concerns a 55 year old female patient who received treatment with synvisc one and later after unknown latency patient is mobile but has difficulty standing, unable to bear weight/ cant put weight on the leg (latency: 2 days), left knee discoloration, mild cellulitis anterior knee, has lost her quality of life, numbness going up into the left hip/numbness in thigh area, fluid was aspirated; after 2 days had difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently/ issues walking due to swelling, pain in hip/ left knee that is painful and ankle, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain above and around injection site, burning above and around injection/ burning in the knee area; after 55 days had elevated crp/ slightly elevated or high normal crp, after unknown latency had joint pain, joint swelling/ swelling has increased, joint stiffness, had sores, environmental allergies numbness going up into the left hip/numbness in thigh area/leg numbness/ very little feeling in left thigh/ numb, muscle pain, weight changes, rashes, and after 85 days had peripheral tear of medical meniscus, osteochondroma of left tibia and after 112 days had left knee pain (severe, sharp).Also device malfunction was identified for the reported lot number.Patient had past treatment with synvisc one.The medical history included psoriasis, injury to the left meniscus requiring surgery in the beginning of (b)(6) 2017, knee arthroscopy 2017, sinus surgery 2005, hysterectomy 2007, knee surgery 2008, bladder 2007, 2011; trochanteric bursitis, sinusitis, gerd (acid reflux).Patient's family history included father: arthritis, copd, mother: cancer, hypertensive disorder; grandparents: diagnosed with unknown disease; sister, brother: arthritis; children: diagnosed with unknown disease; maternal grand father: diagnosed with unknown disease; maternal grand mother: diagnosed with unknown disease.She had strong family history of hip arthritis.She had onset of pain in her late 20s and had injury in (b)(6) 2017 with a fall.She did have a scope on that knee in (b)(6) 2017.Patient had postoperative bleeding.She has had an mri that shows arthritis.Patient was not currently pregnant.Patient had no previous broken bones from a simple fall.Patient had arthritis, high blood pressure, sinusitis, bladder.Patient had allergy to drugs: cefalexin monohydrate (keflex), hydrocodone bitartrate/paracetamol (vicodin) and erythromycin (e-mycin) (slight case of hives).Concomitant medications include esomeprazole (nexium) for reflux; alprazolam (xanax) for insomnia and anxiety; naproxen sodium (aleve) and aleve, amoxicillin, clobetasol topical foam, topical cream, scalp solution, methylprednisolone acetate (depo-medrol), ergocalciferol (vitamin d2), lidocaine, bupivacaine hydrochloride (marcaine), oxycodone hydrochloride/paracetamol (percocet), methylprednisolone (medrol (pak)), sulfamethoxazole/trimethoprim.Patient did not smoke or used tobacco.Patient consumed alcohol socially (1 drink).Patient exercised regularly: 2-3 times per week but did not participate in recreational activities.On (b)(6) 2017, patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (bilateral injection) in knee (batch/lot number: 7rsl021; expiry date: may-2020).Patient received bilateral injection without a lot of success.The synvisc-one that she got was reportedly part the bad back that did have some bacterial contamination although she has had no microscopic evidence of infection.Patient did not do any heavy physical activity after injection.The day after the synvisc-one injection nurse recommended complete bed rest, which helped it improve a little bit.Patient went to bed at night of (b)(6) 2017.On (b)(6) 2017, after 2 days of receiving synvisc one injection, patient woke up around 4 pm.There was a sharp pain in leg (left) and hip.It was reported that when patient got up, she could barely walk and unable to bear weight.Patient had severe swelling, pain, burning above and around injection site, pain in hip and ankle, numbness in thigh area.Patient experienced excruciating pain going up and down her left leg and into the hip and left knee swelling which had not resolved.It was reported that patient had swelling in the left knee.On (b)(6) 2017, the x-ray of knee (bilateral) showed evidence of osteoarticular abnormality but no fracture and no dislocation.Medial joint space narrowing and patellofemoral joint space narrowing.On an unknown date in (b)(6) 2017, patient had numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain patient was able to ambulate for only short periods of time and was unable to perform her job and has lost her quality of life.Her right knee was fine.It was difficult to walk due to pain in hip.Patient took naproxen, put a heating pad on her left hip and rested.It was reported that the pain was radiating from left ankle to left hip and the nurse recommended rest and to stay off her feet.Patient had an appointment two weeks later, patient underwent x-rays at that appointment and purchased a brace to assist her in bearing weight.Patient had swelling in the left knee and numbness going up into the left hip, with no numbness below left knee and sharp shooting pain in left thigh area, left knee discoloration and left knee pain.On an unknown date in (b)(6) 2017, after unknown latency fluid was aspirated and was being cultured and wbc sample was sent for analysis.After synvisc-one left knee pain was 10 out of 10 still on (b)(6) 2017.On the same day, patient had knee joint effusion, which showed no signs of infection within joint.Patient had mri on (b)(6) 2017.It was reported that patient was miserable and had thoughts of having her leg removed.There was no fever.On (b)(6) 2017, 55 days after receiving injection, patient had crp elevated (c-reactive protein).On an unknown date, after unknown latency, patient presented with severe left knee pain.It was reported that the injury was work related.Reportedly no pain was described as sharp, dull, burning.The injury was not a result of a motor vehicle accident: no.Patient was right handed.Patient has had physical or occupational therapy.Patient has had treatment elsewhere: pain scale: 7/10.The diagnostic testing for this problem included: x-ray, mr1.It was reported that patient was seen in follow up for her left knee.The pain had gone from to a 7 following the injection and walking has gotten better as well.Her crp is 6.7 which is in the normal range which is encouraging.She wanted to try to lose weight and understands that her major issue is not meniscal pathology, but degenerative change present.Her left knee was tender anteriorly as well as medially, a little less tender than she was few weeks ago when we gave an injection.She described the pain as a bone pain running down the tibia towards the ankle.It was reported that for osteoarthritis of left knee, patient would have to work on weight loss and she should have 40 pound weight lot and do physical therapy as well.Patient having psoriasis certainly could explain her elevated crps.It was reported that patient's left knee was tender medially and had pain with range of motion.There was some soft tissue swelling and redness there well.Patient complained of pain with weight-bearing, pain on range of motion, also had numbness down into her foot which is probably not related to the knee.There might be more of a peripheral neuropathy.It was reported that x-rays of the knee taken including a flexion view really do not show much in the way of degenerative change, certainly nothing that would recommend surgery for.Patient had osteochondroma of the left tibia.There was also evidence of possible medial meniscus tear from the mri that she had done last year.On (b)(6) 2018, 85 days after starting treatment patient had peripheral tear of medial meniscus (current injury, left knee, initial encounter), osteochondroma of left tibia, osteoarthritis of left knee and leg numbness.Patient would be seen back in three months time to check her progress.The preventive medicinal care included: bmi care goal follow up plan bmt management, immunizations, screening / special tests and bone density test.This patient was seen in followup for her left knee.She did have repeat lab work where her crp has actually dropped from 8 to 7.4 from dec to feb.It was reported that patient would have a rheumatologic profile drawn two years ago and said it came back normal.She has had to use a cane intermittently.Her sed rate was unremarkable.Patient was recommended that knee would be injected.She felt like she had a meniscal tear that might need attention.It was reported that based on what her x-rays, mr1 and workup the arthritis 1 was the bigger culprit going forward.It was reported that patient would like for her to repeat the crp to see which direction they were going and to do it at the same office because there had been some inconsistency and certainly no concern in regarding any persistent or lingering infection.Patient was told by physician to come in for her left knee.Patient would like to get cortisone injection next week as she was going out of town.On an unknown date, after unknown latency, patient had fatigue, weight change, environmental allergies, back pain, joint pain/swelling, joint stiffness, muscle pain, gastric reflux, rash/sores, tingling numbness.Patient denied any hematology, urology, cardiology and respiratory pathology.Patient was followed for left foot plantar fasciitis.Patient was prescribed an exercise program.Patient did not have pain until recently.Her pain was the same as her last flare-up.She admitted not wearing supportive shoes as often as she should.It was reported that after discussing the risks and benefits of treatment patient elected to have an injection of cortisone into their left foot.This was performed using sterile technique and patient tolerated the procedure well.On an unknown date, patient had left heel pain.She has had it for several months, it has gotten to the point where it was very painful and significantly uncomfortable for her and it hurts all the time with every step.It was reported that patient was having difficulty walking at work.She did have morning pain.The symptoms began spontaneously.The quality of pain was moderate.The injury was not work related and the pain was described as sharp dull.The injury was not a result of a motor vehicle accident.Patient did not have physical or occupational therapy.Patient did not have treatment elsewhere.The pain scale was 6/10.Medications taken for this problem included anti inflammatory.On an unknown date, patient had a moderate knee effusion is identified.No baker cyst was noted.Imaged extensor mechanism demonstrates no abnormality.A 0.6 cm near fluid signal intensity focus in the posterior aspect of the interspinous region of the proximal tibia probably represents a degenerative cyst.The finding was consistent with meniscal root avulsion tear of the poster or horn of the medial meniscus, peripheral extrusion of the body segment of the medial meniscus.Patient had compartmental arthritic changes, most pronounced in the medial compartment.Patient had prior medial meniscus.Patient had an apparent tear of the posterior horn of the medial meniscus at the meniscal root is mated.Postsurgical change is a less likely consideration.The body segment of the medial meniscus is peripherally extruded.The lateral meniscus demonstrates no evidence of tear.Reportedly the anterior and posterior cruciate ligaments appeared intact.The medial collateral ligament appears intact.The lateral collateral ligament complex demonstrates no abnormality.The patellar articular cartilage demonstrates mild diffuse thinning land irregularity, predominantly involving the lateral facet.The medial compartment articular cartilage demonstrates diffuse thinning and irregularity.The lateral compartment articular cartilage demonstrated thinning and irregularity.On an unknown date after unknown latency, the sulfamethoxazole/trimethoprim (bactrim) for some mild cellulitis.Her main concern is the continued bleeding she had been having from the medial portal site.The portal site was not currently draining.There was a tiny spot of blood on a band aid that was placed over the site.There was no sign of infection.She was also complained of persistent pain in the knee.The medial portal was steri-stripped and the knee wrapped with an ace.Pt was reassured that the bleeding looks like it had stopped, continued wrapping the knee for several more days, the sulfamethoxazole/trimethoprim (bactrim) as prescribed.On (b)(6) 2018 patient reported to the clinic stating that her left knee is painful and has an altered gait.The patient stated that she does not want an injection but would like to discuss an oral steroid.The patient was given a medrol-dosepak.Corrective treatment: anti inflammatory drug (unspecified), bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depomedrol), dexamethasone (decadron) for joint swelling/ swelling has increased, joint stiffness, joint pain, sores; celecoxib, bupivacaine hydrochloride (marcaine) at a dose of 4 mg, methylprednisolone acetate (depomedrol), dexamethasone (decadron) for peripheral tear of medical meniscus; anti inflammatory drug (unspecified) for muscle pain, tingling, rashes; naproxen (naprosyn), put a heating pad on her left hip and rested, ice, brace for patient is mobile but has difficulty standing, unable to bear weight, difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee discoloration, numbness going up into the left hip/numbness in thigh area, excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left), left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site, left knee pain/pain, fluid was aspirated; celocoxlb,physical/ occupational therapy,anti inflammatory drug (unspecified), bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depomedrol), dexamethasone (decadron) for left knee pain (severe, sharp); not reported for rest events.Outcome: unknown for mild cellulitis anterior knee, rashes, weight changes, sores, tingling, muscle pain, osteochondroma of left tibia, environmental allergies, elevated crp/ slightly elevated or high normal crp, joint swelling/ swelling has increased, joint pain, joint stiffness, peripheral tear of medical meniscus; celocoxlb,physical/ occupational therapy,anti inflammatory drug (unspecified), marcaine, depomedrol, decadron, celecoxib (celebrex) for left knee pain (severe, sharp), not recovered for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for left knee pain (severe,sharp), peripheral tear of medical meniscus, joint swelling/ swelling has increased, joint stiffness, joint pain, device malfunction.Additional information was received on 10-jan-2018 from patient.Events of burning above and around injection, elevated crp, pain in hip and ankle were added along with its details.Concomitant medications and medical history was added.Verbatim updated for the events of left knee pain to left knee pain/pain above and around injection site; left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site; excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed to excruciating pain going up and down her left leg/patient is miserable and has thoughts of having her leg removed/sharp pain in leg (left); numbness going up into the left hip to numbness going up into the left hip/numbness in thigh area; difficult to walk due to pain in hip/difficulty ambulating for long to difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk.Product start date updated.Start date updated for the events of difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk, left knee pain/pain above and around injection site and left knee swelling/swelling in the left knee/left knee was over double the size of the right knee/severe swelling above and around injection site.Clinical course updated.Text was amended accordingly.Follow up was received on 18-jan-2018.Global ptc number was added.Additional information was received on 04-may-2018 from the physician.This case became medically confirmed.The additional events of left knee pain (severe,sharp), joint pain, joint swelling, joint stiffness, had sores, environmental allergies, numbness going up into the left hip/numbness in thigh area/leg numbness, muscle pain, weight changes, rashes, peripheral tear of medical meniscus and osteochondroma of left tibia were added with details.The seriousness criteria of the event of device malfunction updated to required intervention.Patient's medical history and family history was added.Clinical course updated.Text was amended accordingly.Additional information was received on 09-may-2018 from physician.Expiration date of synvisc one.Concomitant medications were added.Event mild cellulitis anterior knee was added.Verbatim of event burning above and around injection updated to burning above and around injection/ burning in the knee area; unable to bear weight updated to unable to bear weight/ cant put weight on the leg; joint swelling updated to joint swelling/ swelling has increased; numbness going up into the left hip/numbness in thigh area/leg numbness updated to numbness going up into the left hip/numbness in thigh area/leg numbness/ very little feeling in left thigh/ numb; difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently updated to difficult to walk due to pain in hip/difficulty ambulating for long/could barely walk/ hip/back hurt due to walking differently/ issues walking due to swelling; elevated crp updated to elevated crp/ slightly elevated or high normal crp.Clinical course updated.Text was amended accordingly.Additional information received on 21-aug-2018 from health care professional.Event verbatim updated for pain in hip and ankle/joint pain to pain in hip and ankle/joint pain/left knee that is painful and event details added.Clinical course updated.Text amended accordingly.Follow-up information was received on 21-aug-2018 and 04-sep-2018.No new information was received.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7185900
• MDR Text Key: 98008697
• Report Number: 2246315-2017-00518
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2018

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: Other
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/10/2018; 05/04/2018; 05/04/2018
• Supplement Dates FDA Received: 01/30/2018; 05/14/2018; 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALEVE (NAPROXEN SODIUM),UNKNOWN; ALEVE (NAPROXEN SODIUM),UNKNOWN; ALEVE (NAPROXEN SODIUM),UNKNOWN; ALEVE(CON.); ALEVE(CON.); AMOXICILLIN (AMOXICILLIN),CAPSULE; AMOXICILLIN (AMOXICILLIN),CAPSULE; AMOXICILLIN (AMOXICILLIN),CAPSULE; BUPIVACAINE (BUPIVACAINE),INJECTION; BUPIVACAINE (BUPIVACAINE),INJECTION; BUPIVACAINE (BUPIVACAINE),INJECTION; CLOBETASOL (CLOBETASOL),UNKNOWN; CLOBETASOL (CLOBETASOL),UNKNOWN; CLOBETASOL (CLOBETASOL),UNKNOWN; DEPO-MEDROL (METHYLPREDNISOLONE ACETATE),INJECTION; DEPO-MEDROL (METHYLPREDNISOLONE ACETATE),INJECTION; DEPO-MEDROL (METHYLPREDNISOLONE ACETATE),INJECTION; E-MYCIN(PREV.); E-MYCIN(PREV.); ESOMEPRAZOLE (ESOMEPRAZOLE),CAPSULE; ESOMEPRAZOLE (ESOMEPRAZOLE),CAPSULE; ESOMEPRAZOLE (ESOMEPRAZOLE),CAPSULE; KEFLEX(PREV.); KEFLEX(PREV.); LIDOCAINE (LIDOCAINE),INJECTION; LIDOCAINE (LIDOCAINE),INJECTION; LIDOCAINE (LIDOCAINE),INJECTION; METHYLPREDNISOLONE (METHYLPREDNISOLONE),TABLET; METHYLPREDNISOLONE (METHYLPREDNISOLONE),TABLET; METHYLPREDNISOLONE (METHYLPREDNISOLONE),TABLET; NAPROXEN (NAPROXEN),UNKNOWN; NAPROXEN (NAPROXEN),UNKNOWN; NAPROXEN (NAPROXEN),UNKNOWN; NAPROXEN(CON.); NAPROXEN(CON.); NEXIUM(CON.); NEXIUM(CON.); OXYCODONE HYDROCHLORIDE,PARACETAMOL,TABLET; OXYCODONE HYDROCHLORIDE,PARACETAMOL,TABLET; OXYCODONE HYDROCHLORIDE,PARACETAMOL,TABLET; SULFAMETHOXAZOLE (SULFAMETHOXAZOLE),UNKNOWN; SULFAMETHOXAZOLE (SULFAMETHOXAZOLE),UNKNOWN; SULFAMETHOXAZOLE (SULFAMETHOXAZOLE),UNKNOWN; SYNVISC ONE(PREV.); SYNVISC ONE(PREV.); VICODIN(PREV.); VICODIN(PREV.); VITAMIN D2 (ERGOCALCIFEROL),CAPSULE; VITAMIN D2 (ERGOCALCIFEROL),CAPSULE; VITAMIN D2 (ERGOCALCIFEROL),CAPSULE; XANAX (ALPRAZOLAM),UNKNOWN; XANAX (ALPRAZOLAM),UNKNOWN; XANAX (ALPRAZOLAM),UNKNOWN; XANAX(CON.); XANAX(CON.)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Female