| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
|
| Patient Problems
Nausea (1970); Pain (1994); Vomiting (2144); Injury (2348); Arthralgia (2355); Joint Swelling (2356); Numbness (2415); No Code Available (3191)
|
| Event Date 11/18/2017 |
|
Event Type
Injury
|
|
Event Description
|
|
This case was cross referenced with cases: (b)(4) (cluster).This unsolicited case from united states was received on (b)(6) 2018 from patient this case concerns a (b)(6) male patient who received treatment with synvisc one and after 1 day had 2 dvts, shooting pain from the knee down/ shooting pain in my ankle, calf was like a hard charley horse, couldn't feel anything all the way to the foot, right knee swelling; after unknown latency left leg was feeling crazy, blood pressure was up, foot was swollen.Also, device malfunction was identified for the reported lot number.No concurrent conditions were reported.Patient has been taking synvisc-one for 3 years.Patient wife has been getting synvisc-one for 5 years.We were used to having some swelling and discomfort when you first get it but we did not typically have a lot of issues.On (b)(6) 2017, prior getting the synvisc-one injection, everything was normal.Patient had an appointment with the doctor for an annual physician and patient checked out ok.The doctor said that patient was good for another 100.000 miles and laughed about that.Patient had no issues.Patient did not actually want to get the synvisc shot, but patient wife who got them every 6 months, talked patient into getting it.Patient did not typically get them until he need them.Patient was not in pain or anything but decided to get the shot.Patient had surgery and accidents before.Patient have crushed his elbow and broken bones since patient have worked in construction most my life, but this pain was different than that pain.Patient was of good health and hygiene.Patient know that he got something injected in me to numb the knee before the synvisc-one was injected.The synvisc-one was prepared in front of me while i was there in the office.Patient does not have diabetes and do not have any allergies to any bird proteins.Patient did not have any prosthetics.On (b)(6) 2017 (friday), patient received treatment with intra articular synvisc one injection once (lot number: 7rsl021; dose and expiration date: not reported) for knee pain in both knees.It was reported that the right knee was fine afterwards and patient had no problems with it.Patient did ice and heat my knee like patient always do.Patient followed the directions and did what i was supposed to like always do.The next morning ((b)(6) 2017), patient right knee was fine and had minute swelling, but not much (latency: 1 day).The left leg was very different.Patient had shooting pain from the knee down.It was terrible pain.Patient could not stand it.That saturday afternoon on (b)(6) 2017, patient went to the er (emergency room).Patient just could not stand the pain anymore.They did 'this and that' and patient had a scan and they found 2 clots, that they called 2 dvts (deep vein thrombosis).Patient calf was like a hard charley horse and patient could not feel anything all the way to the foot.Patient got medicine to calm the clot and pain down and that helped some.On (b)(6) 2017, the pain came back with revenge.The medicine wore off.The pain pills they patient was given did not work.In the er, they gave patient a drip of something that lasted a long time for the pain and the clots.On (b)(6) 2017, patient was ok.Patient know that he was floating on sunday like my feet were not touching the ground.It was like i was in la la land while patient was on those pain meds.On (b)(6) 2017, the medications wore off and the pain started again.The pain was getting worse and worse and worse.Patient was in tears at this point and almost screaming.The pain was so bad that patient could not get up out of the chair.On an unknown date in (b)(6) 2017, latency unknown, patient left leg was feeling crazy and went to the er again.Patient blood pressure was up because of all the pain that was in.It was decided to admit patient into the hospital.Patient had to go to the er on (b)(6) 2017.Patient was in the hospital from (b)(6) 2017.After patient was discharged from the hospital, patient still was in pain and for 3 weeks patient needed a roller with wheels to get around.Going to the bathroom was a project and was difficult.Patient was able to get a urinal to use from the hospital that patient could do in the bed.During this time patient was also off work and worked 32 hours a week.Patient was off of work from (b)(6) 2017 until (b)(6) 2018.Patient got all 'stoved up' being inside for so long and needed to move.Patient suffered every day.Patient was going to therapy 3 days a week.They were trying to stimulate my nerves.At this point, patient leg and calves were ok.Patient knee still hurts and foot was still bad.Patient still have no feeling in heel or ball of my feet.The feeling in the top of my foot has come back.With the bottom of my foot, if patient did not see you touch it, then patient did not know that you did.Patient was having pain like patient never have experienced before.Patient had surgery and accidents before, but this was different pain.Patient have crushed his elbow and broken bones since i have worked in construction most my life, but this pain is different than that pain.The doctor said that the clots must have blocked the nerves and caused them not to work.Some of the pain patient was feeling was like when foot falls asleep and you feel like nails on it when you try to step on it.Patient got that feeling without stepping on it at all.Patient get a shooting feeling on my foot without stepping on it.The doctor decided to put me on gabapentin 300mg at first but patient was now on 1500 mg daily.Patient was also on some kind of blood thinner and take 5 mg.Patient know that it was working because his arms and hands turn blue all the time so it was doing what it should be doing.Patient foot was just not the same.Patient go to step and since patient cannot feel the bottom of my foot, lose balance.Patient foot was swollen some too.Patient have to use a cane.Calf was like a hard charley horsewhen patient go to the therapist, they use tuning forks, do lots of poking of it to re-stimulate the nerve and they use rubber bands too.Patient was still having issues with my foot.Patient did not have shooting pain as much anymore.When patient do have it, it was typically in calf, but it goes away quickly.Recently patient had the shooting pain in my ankle and have never had that before.Patient do still have knee pain.Patient said that you could tell how old i am by how i walk.Patient left foot has always gone to the left, but now patient drag it.It was reported that knee x-rayed fine.The doctor said that patient still have space in my knee and that it was not bone on bone.They did blood work as well to determine if patient had an injection.Patient knees were not aspirated.Patient was told to ice it and do heat and the swelling in knee eventually went down.They were considering doing a nerve study with patient so that they could determine why patient have a lack of feeling, but they want to wait a little bit to see if the therapy would re-stimulate my knee.Patient don't know if he want many more needles in and a nerve study uses needles.Patient did not know if he would get another synvisc-one injection, but his wife would get it.Patient had to go to the er three times.Patient was taken by ambulance to the er one of those times.Patient had x-rays done and other scans.Corrective treatment: medicine (unspecified) for 2 dvts; gabapentin for left leg was feeling crazy; roller with wheels to get around, ice it and do heat for shooting pain from the knee down/ shooting pain in my ankle; elevate it for foot is swollen; ice it and do heat for right knee swelling; not reported for rest events outcome: unknown for 2 dvts, blood pressure was up; not recovered for rest 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: hospitalization for device malfunction, left leg was feeling crazy, blood pressure was up, shooting pain from the knee down/ shooting pain in my ankle; disability for shooting pain from the knee down/ shooting pain in my ankle; important medical event for 2 dvts pharmacovigilance comment: sanofi company comment for dated 2-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later was hospitalized due to severe leg pain and high blood pressure and also had 2 dvt's.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
|
| |
|
Event Description
|
|
Device malfunction [device malfunction] 2 dvts/ blood clots [deep vein thrombosis] left leg was feeling crazy [limb discomfort] blood pressure was up [blood pressure increased] shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee [knee pain] ([condition worsened], [radiating pain]) right knee swelling [swelling of r knee] pain preventing him from walking [difficulty in walking] foot is swollen [swelling of feet] calf was like a hard charley horse [charley horse] couldn't feel anything all the way to the foot; numbness in the foot [loss of sensation] pins and needles sensation [pins and needles] aspartate aminotransferase high [aspartate aminotransferase increased] albumin low [albumin low] fasting glucose high [glucose blood increased] sodium level decreased [sodium blood decreased] eosinophil percentage decreased [eosinophil percentage decreased] egfr low [estimated glomerular filtration rate decreased] lymphocyte percentager decreased [lymphocyte percentage decreased] monocyte percentage increased [monocyte percentage increased] neutrophil count increased [neutrophil count increased] neutrophil percentage increased [neutrophil percentage increased] red cell distribution width increased [red cell distribution width increased] wbc count increased [white blood cell count increased] nausea and vomiting with pain [nausea] vomiting with pain [vomiting].Case narrative: based on the additional information received on 05-sep-2018, the case is now medically confirmed.This case was cross referenced with cases: (b)(4).This unsolicited case from united states was received on 26-jan-2018 from patient.This case concerns a 72 year old male patient (167 cm and 109 kg) who received treatment with synvisc one and after 1 day had 2 dvts/ blood clots, shooting pain from the knee down/ shooting pain in my ankle throbbing pain in left knee, calf was like a hard charley horse, couldn't feel anything all the way to the foot; numbness in the foot, right knee swelling, fasting glucose high, eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased and nausea and vomiting with pain ; pins and needles sensation, aspartate aminotransferase high, sodium level decreased, monocyte percentage increased, wbc count increased (latencies: 4 days); albumin low (latency: 5 days); pain preventing him from walking (latency: 6 days) ; after unknown latency left leg was feeling crazy, blood pressure was up, foot was swollen, numbness in the foot.Also, device malfunction was identified for the reported lot number.The patient's past medical history included swelling, discomfort, surgery with back, rotator cuff surgery, accident, upper limb fracture, multiple fractures, neoplasm malignant with rectal remission, cardiac disorder with leaky aortic valve, gastrooesophageal reflux disease, hypertension, arthritis, appendicectomy, tonsillectomy, non-tobacco user, abstains from alcohol, hernia repair and neuropathy peripheral.The patient's family history included cardiac disorder with father and sister had heart problems and diabetes mellitus with mother.The patient's past vaccination(s) was not provided.No concurrent conditions were reported.Patient has been taking synvisc-one for 3 years.Patient wife has been getting synvisc-one for 5 years.We were used to having some swelling and discomfort when you first get it but we did not typically have a lot of issues.On (b)(6) 2017, prior getting the synvisc-one injection, everything was normal.Patient had an appointment with the doctor for an annual physician and patient checked out ok.The doctor said that patient was good for another 100.000 miles and laughed about that.Patient had no issues.Patient did not actually want to get the synvisc shot, but patient wife who got them every 6 months, talked patient into getting it.Patient did not typically get them until he need them.Patient was not in pain or anything but decided to get the shot.Patient had surgery and accidents before.Patient have crushed his elbow and broken bones since patient have worked in construction most my life, but this pain was different than that pain.Patient was of good health and hygiene.Patient know that he got something injected in me to numb the knee before the synvisc-one was injected.The synvisc-one was prepared in front of me while i was there in the office.Patient does not have diabetes and do not have any allergies to any bird proteins.Patient did not have any prosthetics.Concomitant medications included acetylsalicylic acid (aspirin (e.C.)) for cardiac disorder; citalopram (citalopram) for depression; glucosamine (glucosamine) for nutritional supplementation; levothyroxine (levothyroxine) for thyroid disorder; metoprolol tartrate (metoprolol tartrate); pantoprazole (pantoprazole) for gastrooesophageal reflux disease; fish oil (fish oil) for cardiac disorder; metoprolol tartrate (lopressor); omeprazole (protonix [omeprazole]); spironolactone (spironolactone); and levothyroxine sodium (synthroid).On (b)(6) 2017 (friday), patient received treatment with intra articular synvisc one injection once (lot number: 7rsl021; dose and expiration date: not reported) for knee pain in both knees.It was reported that the right knee was fine afterwards and patient had no problems with it.Patient did ice and heat my knee like patient always do.Patient followed the directions and did what i was supposed to like always do.The next morning (b)(6) 2017), patient right knee was fine and had minute swelling, but not much (latency: 1 day).The left leg was very different.Patient had shooting pain from the knee down.It was terrible pain.Patient could not stand it.That saturday afternoon on (b)(6) 2017, patient went to the er (emergency room).Patient just could not stand the pain anymore.They did 'this and that' and patient had a ultrasound scan and they found 2 clots (left anterior tibial vein and left peroneal vein), that they called 2 dvts (deep vein thrombosis).Also, x-ray was done on (b)(6) 2017 and mild degenerative changes were found in left knee.Patient calf was like a hard charley horse and patient could not feel anything all the way to the foot.Also, he reported that he had throbbing pain to the left knee that radiated back to the knee and into his calf as well as down the front of his shin.The pain exacerbated with bending of his knee and flexion of the foot.On flexing foot forward he had pain to the calf and posterior knee.Patient reported sweating from pain with nausea and vomiting due to pain patient got medicine to calm the clot and pain down and that helped some.It was reported that there were no signs of septic arthritis.Patient also reported og nausea and vomiting with pain.As per the lab values of (b)(6) 2017 it was reported that patient had fasting glucose high, eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased on sunday (b)(6) 2017, the pain came back with revenge.He had excruciating pain to his left leg and it was worse when he walked.The medicine wore off.The pain pills they patient was given did not work.In the er, they gave patient a drip of something that lasted a long time for the pain and the clots.Also, he was given im morphine which did help with his pain.On monday (b)(6) 2017, patient was ok.Patient know that he was floating on sunday like my feet were not touching the ground.It was like i was in lala land while patient was on those pain meds.On tuesday (b)(6) 2017, the medications wore off and the pain started again.The pain was getting worse and worse and worse.Patient was in tears at this point and almost screaming.The pain was so bad that patient could not get up out of the chair.Patient reported pain to left heel and foot as numbness and increased pain with pressure or movement.Also, patient had numbness sin foot that felt asleep but once moved caused a pin and needles sensation.Also, on (b)(6) 2017patient had aspartate aminotransferase high, sodium level decreased, monocyte percentage increased, wbc count increased.On an unknown date in (b)(6) 2017, latency unknown, patient left leg was feeling crazy and went to the er again.Patient blood pressure was up because of all the pain that was in.It was decided to admit patient into the hospital.Patient had to go to the er on 18 and (b)(6) 2017.Patient was in the hospital from (b)(6) 2017.On 22-nov-17, albumin low.On (b)(6) 2017 it was reported that patient complained of pain to the left calf and left foot and in the heel.Pain felt in the skin level as reported by the patient and if he would run finger along his foot his skin would burn and tingle.The pin and needles sensation had prevented him from walking as putting pressure all on skin on the floor significantly aggravated it.He stated that since treatment with anti-inflammatories, his pain had improved over the course of time.Patient was also treated with steroids.After patient was discharged from the hospital, patient still was in pain and for 3 weeks patient needed a roller with wheels to get around.Going to the bathroom was a project and was difficult.Patient was able to get a urinal to use from the hospital that patient could do in the bed.During this time patient was also off work and worked 32 hours a week.Patient was off of work from (b)(6) 2017 until (b)(6) 2018.Patient got all 'stoved up' being inside for so long and needed to move.Patient suffered every day.Patient was going to therapy 3 days a week.They were trying to stimulate my nerves.At this point, patient leg and calves were ok.Patient knee still hurts and foot was still bad.Patient still have no feeling in heel or ball of my feet.The feeling in the top of my foot has come back.With the bottom of my foot, if patient did not see you touch it, then patient did not know that you did.Patient was having pain like patient never have experienced before.Patient had surgery and accidents before, but this was different pain.Patient have crushed his elbow and broken bones since i have worked in construction most my life, but this pain is different than that pain.The doctor said that the clots must have blocked the nerves and caused them not to work.Some of the pain patient was feeling was like when foot falls asleep and you feel like nails on it when you try to step on it.Patient got that feeling without stepping on it at all.Patient get a shooting feeling on my foot without stepping on it.The doctor decided to put me on gabapentin 300mg at first but patient was now on 1500 mg daily.Patient was also on some kind of blood thinner and take 5 mg.Patient know that it was working because his arms and hands turn blue all the time so it was doing what it should be doing.Patient foot was just not the same.Patient go to step and since patient cannot feel the bottom of my foot, lose balance.Patient foot was swollen some too.Patient have to use a cane.Calf was like a hard charley horsewhen patient go to the therapist, they use tuning forks, do lots of poking of it to re-stimulate the nerve and they use rubber bands too.Patient was still having issues with my foot.Patient did not have shooting pain as much anymore.When patient do have it, it was typically in calf, but it goes away quickly.Recently patient had the shooting pain in my ankle and have never had that before.Patient do still have knee pain.Patient said that you could tell how old i am by how i walk.Patient left foot has always gone to the left, but now patient drag it.It was reported that knee x-rayed fine.The doctor said that patient still have space in my knee and that it was not bone on bone.They did blood work as well to determine if patient had an injection.Patient knees were not aspirated.Patient was told to ice it and do heat and the swelling in knee eventually went down.They were considering doing a nerve study with patient so that they could determine why patient have a lack of feeling, but they want to wait a little bit to see if the therapy would re-stimulate my knee.Patient don't know if he want many more needles in and a nerve study uses needles.Patient did not know if he would get another synvisc-one injection, but his wife would get it.Patient had to go to the er three times.Patient was taken by ambulance to the er one of those times.Patient had x-rays done and other scans.Patient was discharged from the hospital on (b)(6) 2017 and was asked to come on the follow up date of (b)(6) 2017.Corrective treatment: medicine (unspecified) for 2 dvts/ blood clots; gabapentin for left leg was feeling crazy; roller with wheels to get around, ice it and do heat for shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee; elevate it for foot is swollen; ice it and do heat for right knee swelling; not reported for rest events.Outcome: unknown for 2 dvts/ blood clots, pain preventing him from walking, for pins and needles sensation, albumin low; recovered for glucose high, sodium level decreased and wbc count increased; not recovered for rest events.Seriousness criteria: hospitalization for device malfunction, left leg was feeling crazy, blood pressure was up, shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee; intervention required for right knee swelling; disability for pain preventing him from walking; medically significant for shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee.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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Follow up was received on 13-mar-2018.Gptc number added.Text amended accordingly.Follow-up information was received on 28-mar-2018.No new information was received.Additional information was received on 05-sep-2018 from healthcare professional.New event of pain preventing him from walking, pins and needles sensation, aspartate aminotransferase high, albumin low, fasting glucose high, sodium level decreased, eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, monocyte percentage increased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased , nausea and vomiting with pain and wbc count increased were added with details.New symptom of pain radiates to the back of his knee and into his calf as well as down the front of his shin was added.Event verbatim updated for 2 dvts to 2 dvts/ blood clots, shooting pain from the knee down/ shooting pain in my ankle to shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee, couldn't feel anything all the way to the foot to couldn't feel anything all the way to the foot; numbness in the foot, medical history and concomitant medication were updated.Clinical course was updated and text amended accordingly.Follow up information was received on13-sep-2018.No new information received.Follow up information was received on 20-sep-2018.No new information received.
|
| |
|
Event Description
|
|
Device malfunction [device malfunction] permanent disabling injuries [injury] compression neuropathy [neuropathy] ([limb discomfort]) 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain [deep vein thrombosis] ([pain]) blood pressure was up [blood pressure increased] pain preventing him from walking [difficulty in walking] shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee [knee pain] ([condition worsened], [radiating pain]) right knee swelling [swelling of r knee] foot is swollen [swelling of feet] calf was like a hard charley horse [charley horse] couldn't feel anything all the way to the foot; numbness in the foot [loss of sensation] pins and needles sensation [pins and needles] aspartate aminotransferase high [aspartate aminotransferase increased] albumin low [albumin low] fasting glucose high [glucose blood increased] sodium level decreased [sodium blood decreased] eosinophil percentage decreased [eosinophil percentage decreased] egfr low [estimated glomerular filtration rate decreased] lymphocyte percentager decreased [lymphocyte percentage decreased] monocyte percentage increased [monocyte percentage increased] neutrophil count increased [neutrophil count increased] neutrophil percentage increased [neutrophil percentage increased] red cell distribution width increased [red cell distribution width increased] wbc count increased [white blood cell count increased] vomiting with pain [vomiting] nausea and vomiting with pain [nausea].Case narrative: based on the additional information received on 05-sep-2018, the case is now medically confirmed.This case was cross referenced with cases: (b)(4).This unsolicited case from united states was received on 26-jan-2018 from patient this case concerns a 72 year old male patient (167 cm and 109 kg) who received treatment with synvisc one and after 1 day had 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain, shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee, calf was like a hard charley horse, couldn't feel anything all the way to the foot; numbness in the foot, right knee swelling, fasting glucose high, eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased and nausea and vomiting with pain ; pins and needles sensation, aspartate aminotransferase high, sodium level decreased, monocyte percentage increased, wbc count increased, , compression neuropathy(latencies: 4 days); albumin low (latency: 5 days); pain preventing him from walking (latency: 6 days) ; after unknown latency blood pressure was up, foot was swollen, numbness in the foot, permanent disabling injuries.Also, device malfunction was identified for the reported lot number.The patient's past medical history included swelling, discomfort, surgery with back, rotator cuff surgery, accident, upper limb fracture, multiple fractures, neoplasm malignant with rectal remission, cardiac disorder with leaky aortic valve, gastrooesophageal reflux disease, hypertension, arthritis, appendicectomy, tonsillectomy, non-tobacco user, abstains from alcohol, hernia repair and neuropathy peripheral.The patient's family history included cardiac disorder with father and sister had heart problems and diabetes mellitus with mother.The patient's past vaccination(s) was not provided.No concurrent conditions were reported.Patient has been taking synvisc-one for 3 years.Patient wife has been getting synvisc-one for 5 years.We were used to having some swelling and discomfort when you first get it but we did not typically have a lot of issues.On (b)(6) 2017, prior getting the synvisc-one injection, everything was normal.Patient had an appointment with the doctor for an annual physician and patient checked out ok.The doctor said that patient was good for another 100.000 miles and laughed about that.Patient had no issues.Patient did not actually want to get the synvisc shot, but patient wife who got them every 6 months, talked patient into getting it.Patient did not typically get them until he need them.Patient was not in pain or anything but decided to get the shot.Patient had surgery and accidents before.Patient have crushed his elbow and broken bones since patient have worked in construction most my life, but this pain was different than that pain.Patient was of good health and hygiene.Patient know that he got something injected in me to numb the knee before the synvisc-one was injected.The synvisc-one was prepared in front of me while i was there in the office.Patient does not have diabetes and do not have any allergies to any bird proteins.Patient did not have any prosthetics.Concomitant medications included acetylsalicylic acid (aspirin (e.C.)) for cardiac disorder; citalopram (citalopram) for depression; glucosamine (glucosamine) for nutritional supplementation; levothyroxine (levothyroxine) for thyroid disorder; metoprolol tartrate (metoprolol tartrate); pantoprazole (pantoprazole) for gastrooesophageal reflux disease; fish oil (fish oil) for cardiac disorder; metoprolol tartrate (lopressor); omeprazole (protonix [omeprazole]); spironolactone (spironolactone); and levothyroxine sodium (synthroid).On (b)(6) 2017 (friday), patient received treatment with intra articular synvisc one injection once (lot number: 7rsl021; dose and expiration date: not reported) for knee pain and chronic osteoarthritis in both knees.It was reported that the right knee was fine afterwards and patient had no problems with it.Patient did ice and heat my knee like patient always do.Patient followed the directions and did what i was supposed to like always do.The next morning ((b)(6) 2017), patient right knee was fine and had minute swelling, but not much (latency: 1 day).The left leg was very different.Patient had shooting pain from the knee down.It was terrible pain.Patient could not stand it.That saturday afternoon on (b)(6) 2017, patient went to the er (emergency room).Patient just could not stand the pain anymore.They did 'this and that' and patient had a ultrasound scan and they found 2 clots (left anterior tibial vein and left peroneal vein), that they called 2 dvts (deep vein thrombosis).It was also reported that patient had deep vein thrombosis in the left anterior tibial vein and left perineal pain.It was also reported that due to acute and excruciating pain, patient was required to have two additional emergency department visits.Also, x-ray was done on (b)(6) 2017 and mild degenerative changes were found in left knee.Patient calf was like a hard charley horse and patient could not feel anything all the way to the foot.Also, he reported that he had throbbing pain to the left knee that radiated back to the knee and into his calf as well as down the front of his shin.The pain exacerbated with bending of his knee and flexion of the foot.On flexing foot forward he had pain to the calf and posterior knee.Patient reported sweating from pain with nausea and vomiting due to pain patient got medicine to calm the clot and pain down and that helped some.It was reported that there were no signs of septic arthritis.Patient also reported og nausea and vomiting with pain.As per the lab values of (b)(6) 2017 it was reported that patient had fasting glucose high, eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased on sunday (b)(6) 2017, the pain came back with revenge.He had excruciating pain to his left leg and it was worse when he walked.The medicine wore off.The pain pills they patient was given did not work.In the er, they gave patient a drip of something that lasted a long time for the pain and the clots.Also, he was given im morphine which did help with his pain.On monday (b)(6) 2017, patient was ok.Patient know that he was floating on sunday like my feet were not touching the ground.It was like i was in lala land while patient was on those pain meds.On (b)(6) 2017, due to unresolved pain, he was admitted to the hospital.On tuesday 21-nov-2017, the medications wore off and the pain started again.The pain was getting worse and worse and worse.Patient was in tears at this point and almost screaming.The pain was so bad that patient could not get up out of the chair.Patient reported pain to left heel and foot as numbness and increased pain with pressure or movement.Also, patient had numbness sin foot that felt asleep but once moved caused a pin and needles sensation.Also, on (b)(6) 2017 patient had aspartate aminotransferase high, sodium level decreased, monocyte percentage increased, wbc count increased.He was hospitalized for four days and was closely monitored and evaluated by the specialists in the cardiology and orthopedic departments which led to a compression neuropathy diagnosis.On an unknown date in (b)(6) 2017, latency unknown, patient left leg was feeling crazy and went to the er again.Patient blood pressure was up because of all the pain that was in.It was decided to admit patient into the hospital.Patient had to go to the er on (b)(6) 2017.Patient was in the hospital from (b)(6) 2017.On 22-nov-17, albumin low.On (b)(6) 2017, it was reported that patient complained of pain to the left calf and left foot and in the heel.Pain felt in the skin level as reported by the patient and if he would run finger along his foot his skin would burn and tingle.The pin and needles sensation had prevented him from walking as putting pressure all on skin on the floor significantly aggravated it.He stated that since treatment with anti-inflammatories, his pain had improved over the course of time.Patient was also treated with steroids.After patient was discharged from the hospital, patient still was in pain and for 3 weeks patient needed a roller with wheels to get around.Going to the bathroom was a project and was difficult.Patient was able to get a urinal to use from the hospital that patient could do in the bed.During this time patient was also off work and worked 32 hours a week.Patient was off of work from(b)(6) 2017 until (b)(6) 2018.Patient got all 'stoved up' being inside for so long and needed to move.Patient suffered every day.Patient was going to therapy 3 days a week.They were trying to stimulate my nerves.At this point, patient leg and calves were ok.Patient knee still hurts and foot was still bad.Patient still have no feeling in heel or ball of my feet.The feeling in the top of my foot has come back.With the bottom of my foot, if patient did not see you touch it, then patient did not know that you did.Patient was having pain like patient never have experienced before.Patient had surgery and accidents before, but this was different pain.Patient have crushed his elbow and broken bones since i have worked in construction most my life, but this pain is different than that pain.The doctor said that the clots must have blocked the nerves and caused them not to work.Some of the pain patient was feeling was like when foot falls asleep and you feel like nails on it when you try to step on it.Patient got that feeling without stepping on it at all.Patient get a shooting feeling on my foot without stepping on it.The doctor decided to put me on gabapentin 300mg at first but patient was now on 1500 mg daily.Patient was also on some kind of blood thinner and take 5 mg.Patient know that it was working because his arms and hands turn blue all the time so it was doing what it should be doing.Patient foot was just not the same.Patient go to step and since patient cannot feel the bottom of my foot, lose balance.Patient foot was swollen some too.Patient have to use a cane.Calf was like a hard charley horse.When patient go to the therapist, they use tuning forks, do lots of poking of it to re-stimulate the nerve and they use rubber bands too.Patient was still having issues with my foot.Patient did not have shooting pain as much anymore.When patient do have it, it was typically in calf, but it goes away quickly.Recently patient had the shooting pain in my ankle and have never had that before.Patient do still have knee pain.Patient said that you could tell how old i am by how i walk.Patient left foot has always gone to the left, but now patient drag it.It was reported that knee x-rayed fine.The doctor said that patient still have space in my knee and that it was not bone on bone.They did blood work as well to determine if patient had an injection.Patient knees were not aspirated.Patient was told to ice it and do heat and the swelling in knee eventually went down.They were considering doing a nerve study with patient so that they could determine why patient have a lack of feeling, but they want to wait a little bit to see if the therapy would re-stimulate my knee.Patient don't know if he want many more needles in and a nerve study uses needles.Patient did not know if he would get another synvisc-one injection, but his wife would get it.Patient had to go to the er three times.Patient was taken by ambulance to the er one of those times.Patient had x-rays done and other scans.Patient was discharged from the hospital on (b)(6) 2017 and was asked to come on the follow up date of (b)(6) 2017.On the unknown date, it was reported that patient sustained severe and permanent, disabling injuries which was not resolved.Corrective treatment: medicine (unspecified) for 2 dvts/ blood clots; gabapentin for left leg was feeling crazy; roller with wheels to get around, ice it and do heat for shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee; elevate it for foot is swollen; ice it and do heat for right knee swelling; not reported for rest events.Outcome: unknown for compression neuropathy, pain preventing him from walking, for pins and needles sensation, albumin low; recovered for glucose high, sodium level decreased and wbc count increased; not recovered for 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain, permanent disabling injuries and rest events.Seriousness criteria: hospitalization for device malfunction, left leg was feeling crazy, blood pressure was up, shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee, 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain, compression neuropathy; intervention required for right knee swelling; disability for pain preventing him from walking, permanent disabling injury; medically significant for shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee.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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Follow up was received on 13-mar-2018.Gptc number added.Text amended accordingly.Follow-up information was received on 28-mar-2018.No new information was received.Additional information was received on 05-sep-2018 from healthcare professional.New event of pain preventing him from walking, pins and needles sensation, aspartate aminotransferase high, albumin low, fasting glucose high, sodium level decreased, eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, monocyte percentage increased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased, nausea and vomiting with pain and wbc count increased were added with details.New symptom of pain radiates to the back of his knee and into his calf as well as down the front of his shin was added.Event verbatim updated for 2 dvts to 2 dvts/ blood clots, shooting pain from the knee down/ shooting pain in my ankle to shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee, couldn't feel anything all the way to the foot to couldn't feel anything all the way to the foot; numbness in the foot, medical history and concomitant medication were updated.Clinical course was updated, and text amended accordingly.Follow up information was received on13-sep-2018.No new information received.Follow up information was received on 20-sep-2018.No new information received.Additional information was received on 27-feb-2019 from the lawyer.Verbatim of 2 dvts/ blood clots updated to 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain.Event of compression neuropathy was added.Seriousness criteria for 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain was added as hospitalization.Event of permanent disabling injury was added.Outcome for 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain was updated to not recovered from unknown.Event of left leg was feeling crazy was made symptom to compression neuropathy.Clinical course updated.Text amended accordingly.
|
| |
|
Event Description
|
|
Device malfunction [device malfunction] permanent disabling injuries [injury] compression neuropathy [nerve compression] ([peripheral neuropathic pain], [limb discomfort], [numbness in leg], [weakness], [paraesthesia]) 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain/deep vein thrombosis/2 clots in lower leg [deep vein thrombosis] ([radiating pain], [pain in extremity]) blood pressure was up [blood pressure increased] pain preventing him from walking/walker user/walking is slow and unsteady/gait is antalgic [difficulty in walking] shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee/severe pain in the left knee/knee pain/joint line tenderness [knee pain] ([condition worsened]) right knee swelling/unilateral swelling [swelling of r knee] couldn't feel anything all the way to the foot; numbness in the foot [loss of sensation] aspartate aminotransferase high [aspartate aminotransferase increased] albumin low [albumin low] fasting glucose high [glucose blood increased] sodium level decreased [sodium blood decreased] eosinophil percentage decreased [eosinophil percentage decreased] egfr low [estimated glomerular filtration rate decreased] lymphocyte percentager decreased [lymphocyte percentage decreased] monocyte percentage increased [monocyte percentage increased] neutrophil count increased [neutrophil count increased] neutrophil percentage increased [neutrophil percentage increased] red cell distribution width increased [red cell distribution width increased] wbc count increased [white blood cell count increased] vomiting with pain [vomiting] left tibial mononeuropathy [mononeuropathy] sleep is poor due to the shocking pain in his left foot [poor sleep] mood is depressed [depressed mood] the left foot is cooler than the right over its anterior aspect [cold feet] he bruises easily [increased tendency to bruise] diminished weight bearing on the left and wide based [weight bearing difficulty] 4/5 weakness of toe flexors and ankle plantar flexors [weakness in extremity] can not stand on the toes of the left foot [difficulty in standing] position sense is diminished in toes [loss of proprioception] lesion of the left tibial nerve [peripheral nerve lesion] grossly limited with pain [joint range of motion decreased] plantar fascitis/sharp shooting severe pain in bottom of foot/hypersensitivity of plantar surface of foot [plantar fasciitis] limited on daily activities [activities of daily living impaired] sinus rhythm [sinus rhythm] sinus bradycardia [sinus bradycardia] creatinine high [creatinine increased] basophil count decreased [basophil count decreased] foot is swollen [swelling of feet] calf was like a hard charley horse [charley horse] nausea and vomiting with pain [nausea] case narrative: initial information received on 05-sep-2018 regarding an unsolicited valid serious case received from a physician and patient from united states.This case involves a 72 years old male patient (170 cm and 106 kg) who experienced device malfunction (latency: 1 day), permanent disabling injuries(latency: unknown), compression neuropathy (latency: 5 days), 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain/deep vein thrombosis (latency: 1 day), blood pressure was up (latency: unknown), pain preventing him from walking/walker user/walking is slow and unsteady/gait is antalgic (latency: 6 days), shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee/severe pain in the left knee/knee pain/joint line tenderness (latency: 1 day), right knee swelling/unilateral swelling (latency: 1 day), couldn't feel anything all the way to the foot; numbness in the foot (latency: 1 day) , pins and needles sensation/intermittent shocking that involves the medial sole and arch of the left foot/pin is diminished over the left sole and toes as well as distal posterior foreleg, aspartate aminotransferase high (latency: 4 days), albumin low (latency: 5 days), fasting glucose high (latency: 1 day), sodium level decreased (latency: 4 days), eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased (latency: 1 day), monocyte percentage increased, wbc count increased (latency: 4 days), vomiting with pain (latency: 1 day), nausea and vomiting with pain (latency: 1 day), left tibial mononeuropathy, sleep is poor due to the shocking pain in his left foot, mood is depressed, the left foot is cooler than the right over its anterior aspect, he bruises easily (latency: unknown), diminished weight bearing on the left and wide based, 4/5 weakness of toe flexors and ankle plantar flexors, cannot stand on the toes of the left foot, position sense is diminished in toes, lesion of the left tibial nerve, lesion of the left tibial nerve and neuropathic pain, plantar fascitis/sharp shooting severe pain in bottom of foot/hypersensitivity of plantar surface of foot, limited on daily activities (latency: unknown), sinus rhythm (latency: 1 month 24 days), sinus bradycardia (latency: 8 months 10 days), creatinine high (latency: 1 month 16 days), basophil count decreased (latency: 5 days), foot is swollen (latency: unknown), calf was like a hard charley horse (latency: 1 day), while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Patient has been taking hylan g-f 20, sodium hyaluronate injection for 3 years.Patient wife has been getting hylan g-f 20, sodium hyaluronate injection for 5 years.On 15-nov-2017, prior getting the hylan g-f 20, sodium hyaluronate injection, everything was normal.Patient was not in pain or anything but decided to get the shot.Patient know that he got something injected in me to numb the knee before the hylan g-f 20, sodium hyaluronate injection was injected.The patient's past medical history/concurrent conditions included myalgia (due to statins), myositis, hyperlipidaemia, hypothyroidism, bronchitis acute, onychomycosis of toe nail, fever, rotator cuff strain, acute sinusitis, snoring, lbp (lower back pain), leukocytosis, inappropriate diet and eating habits, lack of physical exercise/physical inactivity, positive depression screening, risk of falls, stress, obesity/obesity, morbid (moderate obesity with weight loss), fatigue, anxiety, overweight, rectal cancer with rectal cancer surgery (1980), left leg dvt, bilateral carotid disease, bicuspid aortic valve, aortic valve stenosis, bilateral carotid disease, bicuspid aortic valve, aortic valve stenosis, dyslipidemia, mitral valve disorder, tricuspid valve disorders specified as non-rheumatic, shoulder surgery, surgery on arms, allergy to simvastatin, hypertensive heart disease, left leg edema, swelling, discomfort, crushed his elbow, broken bones accident, cancer with rectal remission, cardiac disorder with leaky aortic valve, acid reflux/gastrooesophageal reflux disease/gerd, hypertension, arthritis, appendicectomy, tonsillectomy, abstains from alcohol, hernia repair, peripheral neuropathy/left leg neuropathic pain, thyroid disease, high cholesterol, coronary artery disease, cancer rectal, colectomy, back surgery, neck surgery, heart surgery and rt rotator cuff repair/rotator cuff surgery.The patient family history included coronary artery disease, cardiovascular disease, dementia and cancer.The patient's father had cerebrovascular accident, hypertension, diabetes mellitus, alzheimer's disease and dyslipidemia.Patient's mother had hypertension, diabetes mellitus, dyslipidemia, hypotension and breast cancer.His sister had diabetes mellitus.Patient was a former smoker (quit 21 years ago; end date: 25-nov-1995) and occasional drinker but currently abstains from alcohol and never drinks.Concomitant medications included acetylsalicylic acid (aspirin), fish oil for cardiac disorder; citalopram for depression; glucosamine for nutritional supplementation; levothyroxine for thyroid disorder; metoprolol tartrate; pantoprazole for gastrooesophageal reflux disease; metoprolol tartrate (lopressor); omeprazole (protonix); spironolactone; levothyroxine sodium (synthroid); ranolazine (ranexa); rosuvastatin calcium; prasugrel hcl; pantoprazole sodium; citalopram hydrobromide (celexa); nebivolol hydrochloride (bystolic); gabapentin; acetylsalicylic acid (ecotrin); chondroitin sulfate; glucosamine hydrochloride (osteo bi-flex); cascara sagrada (rhamnus purshiana); bacopa monnieri herb, camellia sinensis leaf, curcuma longa rhizome, silybum marianum seed, withania somnifera root (protandim); apixaban (eliquis), spironolactone (aldactone).On 17-nov-2017, patient received hylan g-f 20, sodium hyaluronate via intra articular route once (lot number: 7rsl021; dose: unk) for bilateral knee osteoarthritis.Patient right knee was fine afterwards with no problems.Patient did ice and heat, followed the directions.On 18-nov-2017, patient right knee was fine with minute swelling (latency: 1 day).Left leg was different.Patient had shooting pain from knee down which was terrible and he could not stand.In afternoon, patient went to er (emergency room) and could not stand the pain anymore.Patient had ultrasound and they found 2 clots (left anterior tibial vein and left peroneal vein), that they called 2 dvts (deep vein thrombosis).Patient also had deep vein thrombosis in the left anterior tibial vein and left perineal pain.Due to acute and excruciating pain, patient was required to have two additional emergency department visits.X-ray was also done and mild degenerative changes were found in left knee.Patient calf was like a hard charley horse and patient could not feel anything all way to foot.Also, patient had throbbing pain to left knee radiating back to knee and into calf as well as down the front of his shin.The pain exacerbated with bending of knee and flexion of foot.On flexing foot forward he had pain to the calf and posterior knee.Patient sweated from pain with nausea and vomiting due to pain and got medicine to calm the clot and pain down that helped him.There were no signs of septic arthritis.Patient also had nausea and vomiting with pain.On 18-nov-2017 patient had fasting glucose high, eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased.On 19-nov-2017, the pain came back with revenge.He had excruciating pain to his left leg and it was worse when he walked.The medicine wore off.The pain pills did not work.In the er, patient was given a drip of something that lasted a long time for pain and clots.Also, he was given im morphine which did help with his pain.On 20-nov-2017, patient was ok.Patient was floating on sunday like his feet were not touching ground.On 21-nov-2017, due to unresolved pain, he was admitted to hospital.On 21-nov-2017, the medications wore off and the pain started again.The pain was getting worse.Patient was in tears and almost screaming.The pain was so bad that patient could not get up out of chair.Patient hd pain to left heel and foot as numbness and increased pain with pressure or movement.Also, patient had numbness in foot that felt asleep but once moved caused a pin and needles sensation.On 21-nov-2017, patient had aspartate aminotransferase high, sodium level decreased, monocyte percentage increased, wbc count increased, basophil count decreased.He was hospitalized for four days and was closely monitored and evaluated by the specialists in cardiology and orthopedic departments which led to a compression neuropathy diagnosis.On an unknown date in nov-2017, patient left leg was feeling crazy and went to er.Patient blood pressure was up.Patient had to go to the er on 18 and 19-nov-2017.Patient was in the hospital from 21 to 25-nov-2017.On 22-nov-17, albumin low.On 23-nov-2017, it was reported that patient complained of pain to the left calf and left foot and in he heel.Pain felt in skin level and if he would run finger along his foot his skin would burn and tingle.The pin and needles sensation had prevented him from walking as putting pressure all on skin on floor.Since treatment with anti-inflammatories, his pain had improved.Patient was treated with steroids.Secondary to this, the patient developed a non-serious compression neuropathy, associated with left leg pain and severe pain from the knee down to the foot; numbness in leg and foot; paresthesia of foot and burning sensation in ball of left foot and weakness.The patient developed a sharp shooting severe pain in bottom of foot and hypersensitivity of planter surface of foot.The pain affected left foot and ankle and was not associated with swelling.The patient's daily activities got limited and became a walker user.After patient was discharged from the hospital, patient still was in pain and needed a roller with wheels to get around.Patient was able to get a urinal to use from hospital.On 02-jan-2018, patient had high creatinine.Patient was off work and worked 32 hours a week from 20-nov-2017 until 08-jan-2018.Patient got all 'stoved up' being inside for so long and needed to move.Patient was going to therapy 3 days a week.They were trying to stimulate my nerves.At this point, patient leg and calves were ok.Patient knee still hurt and foot was bad.Patient had no feeling in heel or ball of feet.The feeling in the top of my foot has come back.With the bottom of my foot, if patient did not see you touch it, then patient did not know that you did.Patient was having pain like patient never have experienced before.Patient had surgery and accidents before, but this was different pain.The clots must have blocked the nerves and caused them not to work.Some of the pain patient was feeling was like when foot falls asleep and you feel like nails on it when you try to step on it.Patient got that feeling without stepping on it at all.Patient got a shooting feeling on my foot without stepping on it.The doctor decided to put me on gabapentin 300 mg at first but patient was now on 1500 mg daily.Patient was also on some kind of blood thinner and take 5 mg.Patient know that it was working because his arms and hands turn blue all time.Patient foot was just not the same.Patient go to step and since patient cannot feel the bottom of my foot, lose balance.Patient foot was swollen too and he used cane.When patient go to the therapist, they use tuning forks, do lots of poking of it to re-stimulate the nerve and they use rubber bands too.Patient was still having issues with foot.Patient did not have shooting pain anymore.Recently patient had shooting pain in his ankle and have never had that before.Patient do still have knee pain.Patient drag his left foot.It was reported that knee x-rayed fine.Patient had space in his knee and not bone on bone.They did blood work as well to determine if patient had an injection.Patient knees were not aspirated.Patient iced and do heat and swelling in knee eventually went down.They were considering doing a nerve study with patient so that they could determine why patient have a lack of feeling, but they wanted to wait a little bit to see if the therapy would re-stimulate his knee.Patient did not know if he would get another hylan g-f 20, sodium hyaluronate injection, but his wife would get it.Patient had to go to the er three times.Patient was taken by ambulance to the er one of those times.Patient had x-rays done and other scans.Patient was discharged from the hospital on 25-nov-2017 and was asked to come on the follow up date of 04-dec-2017.On the unknown date, it was reported that patient sustained severe and permanent, disabling injuries which was not resolved.On 04-dec-2017, patient presented in the healthcare facility and stated that had significant pain in thigh, the calf and knee area was in emergency room around 18-nov-2017 and ultimately diagnosed with left lower extremity and was placed om some medication after admission, patient gradually improved in the thigh and the calf, but the left foot was numb.On the same day, patient had blood pressure of 142/78 mmhg.On 18-dec-2017, patient reported he had return of feeling except in bottom of left foot.On 02-jan-2018, patient was better and pain was better.On the same day, his cholesterol level was 213 mg/dl (high), creatinine was 1.37 mg/dl (high), gfr was 51 (low) and ldl was 147 mg/dl (high).On 10-jan-2018, his blood pressure was 106/65 mmhg (low) and pulse rate was 91 (high) and had sinus rhythm.On 13-jul-2018, cholesterol was 202 mg/dl (high), ldl was 161 mg/dl (high) and non-hdl was 162 mg/dl (high).On 12-jan-2018, it was reported that patient no longer had sharp, shooting pain in foot, paresthesia continued to diminish and symptoms were more of plantar fasciitis.During his visit on 26-jan-2018 in the hospital, he was observed with pain 6.0-6/10 pain.He was also observed with mildly gait antalgic.In his both knees, medial joint line tenderness was observed.It was also observed that both knees were grossly limited and with pain.On 08-feb-2018, patient reported that sensation in lower leg and foot was returning but the heel was still numb.On 13-jul-2018, patient had high ldl cholesterol, total chol/hdl ratio.On 27-jul-2018, ecg revealed sinus bradycardia.On 05-sep-2018, patient reported significantly decreased hypersensitivity of planter surface of foot and said that rubbing bottom of foot with various surfaces had decreased the intensity of sharp pains.On 24-jun-2019, respiration rate 20, pulse rate 71 bpm, blood pressure 121/77 mm/hg and pain level 5/10.On 24-jun-2019, in the evening patient developed severe pain in the left knee.On an unknown date, patient had problems with the left calf and foot and diagnosed as a symptom of left tibial mononeuropathy.As of unknown date, patient had numbness of the left sole and toes.There was residual intermittent shocking that involved the medial sole and arch of the left foot and gabapentin 1200 mg a day helped him with his symptoms.As of unknown date, patient walking was slow and unsteady and had pain in left foot when he walked barefoot.Patient had to wear orthotics when weight bearing.As of unknown date, patient had residual neuropathic pain as a result of deep vein thrombosis that included lesion of left tibial nerve.Corrective treatment: gabapentin (neurotonin) for compression neuropathy; apixaban (eliquis) for 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain/deep vein thrombosis/2 clots in lower leg; walking aid user for pain preventing him from walking/walker user/walking is slow and unsteady/gait is antalgic; roller with wheels to get around, ice it and do heat, hydrocodon and morphine for shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee/severe pain in the left knee/knee pain/joint line tenderness; icing, heat and steroids for right knee swelling/unilateral swelling; elevation for foot is swollen.Outcome: not recovered/not resolved for shooting pain from the knee down/ shooting pain in my ankle/ throbbing pain in left knee/severe pain in the left knee/knee pain/joint line tenderness, pain got worse; pain exacerbated with bending of knee and flexion of foot; on flexing foot forward he has pain to calf and posterior knee; excruciating pain; worse when he walks, foot is swollen, calf was like a hard charley horse, couldn't feel anything all the way to the foot; numbness in the foot, eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, monocyte percentage increased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased, permanent disabling injuries; recovered/resolved for aspartate aminotransferase high, albumin low, fasting glucose high, sodium level decreased, , wbc count increased; recovering/resolving for compression neuropathy, left leg pain/severe pain from the knee down to the foot/significant pain in the thigh/left calf pain, plantar fascitis/sharp shooting severe pain in bottom of foot/hypersensitivity of plantar surface of foot, limited on daily activities; unknown for rest all events a pharmaceutical technical complaint (ptc) was initiated on 26-jan-2018 for synvisc one with lot number 7rsl021 and global ptc number: 52282 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received in the form of investigation summary on 26-jan-2018.Ptc results and number was added.Follow-up information was received on 28-mar-2018.No new information received.Additional information was received on 05-sep-2018 from healthcare professional.New event of pain preventing him from walking, pins and needles sensation, aspartate aminotransferase high, albumin low, fasting glucose high, sodium level decreased, eosinophil percentage decreased, egfr low, lymphocyte percentage decreased, monocyte percentage increased, neutrophil count increased, neutrophil percentage increased, red cell distribution width increased, nausea and vomiting with pain and wbc count increased were added with details.Event verbatim updated.Medical history and concomitant medication updated.Clinical course updated, and text amended accordingly.Follow up information was received on13-sep-2018.No new information received.Follow up information was received on 20-sep-2018.No new information received.Additional information was received on 27-feb-2019 from the lawyer.Verbatim updated.Seriousness criteria for 2 dvts/ blood clots/ deep vein thrombosis in the left anterior tibial vein/left perineal pain was added as hospitalization.Event of permanent disabling injury was added.Outcome updated.Event of left leg was feeling crazy was made symptom to compression neuropathy.Clinical course updated.Text amended accordingly.Additional information was received on 28-jun-2019 from healthcare professional.Labs added.New events added.Concomitant and medical history added.Upon internal review on 12-jun-2019, all the information from case (b)(4) has been merged into this case.Clinical course updated.Text amended accordingly.
|
| |
|
Search Alerts/Recalls
|
|
