| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Atrial Fibrillation (1729); Unspecified Infection (1930); Pain (1994); Thyroid Problems (2102); Arthralgia (2355); Disability (2371); Joint Disorder (2373); No Code Available (3191)
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| Event Date 01/01/2017 |
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Event Type
Injury
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Event Description
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This unsolicited case from united states was received on (b)(6) 2018 from the physician.This case concerns a female patient with unspecified age who received treatment with synvisc one injection and after unknown latency the patient developed an infection in her knee.No relevant medical history, past drugs and concurrent condition was reported.On an unknown date, the patient received treatment with intra-articular synvisc one injection at the once (dose, indication, lot number and expiration date: not reported).On an unknown date, after unknown latency of receiving the injection, the patient developed an infection in her knee requiring hospitalization.The preliminary investigation revealed that the cause of the infection was due to contarnination of the synvisc one.Corrective treatment: not reported a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: in-patient hospitalization pharmacovigilance comment: sanofi company comment dated 08-feb-2018: this case concerns a female patient who received injection synvsic one and was hospitalized with knee infection.The role of synvisc one cannot be denied for the occurrence of the event based upon the temporal relationship.However, the information regarding patient's medical history, concurrent conditions, concomitant medications and other risk factors will aid in comprehensive assessment of this case.
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Event Description
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This unsolicited case from united states was received on 08-feb-2018 from the physician.This case concerns a 78 years old female patient who received treatment with synvisc one injection and after unknown latency had high cholesterol or triglycerides, high blood pressure, developed an infection in her knee, bacterial arthritis, developed infection, become ill, atrial fibrillation (irregular heartbeat), underactive thyroid and persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee, crepitation with flexion-extensiion of the knee.Also, device malfunction was identified for the reported lot number.Patient was allergic to eggs (egg derived), codeine (incoherent or faint), penicillins (syncope), some avain products (aches).Patient never smoked and was occasional alcohol drinker.Patient had claustrophobia.She had synvisc that was administered over 3 weeks and it did not work as well.It was reported that her arthritis just might be getting worse in the synvisc that was not working as well.Patient had knee pain (right), unilateral primary osteoarthritis of right knee, right knee joint varus deformity.On (b)(6) 2017, patient had an appointment with md.The same day, patient's physical examination of right knee revealed there was an acquired varus deformity.No effusion or discoloration of the right knee was noted.There was full extension to around 20 degree of flexion.There was no instability in flexion or extension.Patellar was stable.The same day, patient underwent right knee 3 view x-ray: an acquired varus deformity.There were degenerative changes present in the joint with narrowing of the medical compartment and some patellofemoral disease.No acute bone injury was noted.The patient was prescribed synvisc one injection into the right knee.Patient was ambulatory with walker.Concomitant medications included latanoprost, bumetanide (bumex), levothyroxine sodium (synthroid), pantoprazole sodium (protonix), ranitidine hydrochloride (zantac), diclofenac potassium (voltaren), rosuvastatin calcium (crestor), terconazole (terazol 7), rivaroxaban (xarelto).On (b)(6) 2017, patient arrived for synvisc one injection into the right knee.The patient tolerated the procedure well.The same day, physical exam: no acquired varus deformity, no effusion and discoloration of knee.There was tenderness over the medial joint line, range of motion remained the same.It was confirmed that patient did not have history of prior adverse reaction, active infections or relevant allergies.No effusion, erythema or warmth.Skin was clear.Skin was prepped with betadine.Topical anesthesia was achieved with ethyl chloride.The same day, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (indication: not reported; lot number: 6rsl037a and expiration date: 31-aug-2019).On (b)(6) 2017, patient returned to office with complaints of some persistent pain present in the right knee.She might have a little inflammatory reaction as a result of synvisc one.The same day, patient received 2 cc of bupivacaine hydrochloride (marcaine) and 40 mg of triamcinolone acetonide (kenalog) injection in the right knee joint.Patient was instructed to avoid strenuous activity for next 24-48 hours to use ice, nsaids or tylenol for pain as needed.On (b)(6) 2017, patient presented with low back pain, hip pain (right and left), inflammation of sacroiliac joint (patient was prescribed with diclofenac/voltaren 1 % topical gel, 2 g four times a day), degeneration of lumbar intervertebral disc (prescribed with oral medrol pack 4 mg tablets) and lumbar spondylosis.Physical examination revealed full range of motion the joints of the lower extremities.There was absolutely no weakness on manual muscle testing of the muscles of the lower extremity specifically the hip flexors, quadriceps, hamstring, doorsi and plantar flexors.There was no edema, discoloration lower extremity and good pulses were noted.There was tenderness to palpation of the lumbosacral junction as well as over the area the sacroiliac joint on the left.Same day, patient underwent lumbar-spine x-ray that revealed levoscoliosis.There was severe and advanced degenerative disc disease/arthritic changes present at multiple levels in the lumbar spine as well as degenerative changes seen in the facet joints.There appeared to be perhaps an old compression fracture superior end plate of l3.Patient also underwent pelvis x-ray revealed no acute bony injury.X-rays do reveal significant sclerosis along the left sacroiliac joint.X-ray revealed what appears to be some chronic irritation and inflammation of the sacroiliac joint on the left.Patient was offered physical therapy but she wanted to hold off.Patient was not having any radicular complaints and neurological examination was completely within normal limits.On (b)(6) 2017, patient presented with chronic low back pain and knee pain, lumbar spondylosis, spinal stenosis of lumbar region.Patient was not having any radicular complaints at this time and no change in bowel or bladder function.She was on anticoagulants and so could not take any nsaids.Physical examination revealed no effusion discoloration.There was mild varus deformity, full extension to about 110 degree of flexion.There was no instability.There was pain over the medial joint line.There was some crepitance with flexion-extension of the knee.Patient received 2 cc of bupivacaine hydrochloride (marcaine) and 40 mg of methylprednisolone acetate (depo-medrol) into the right knee joint, for symptomatic relief of the discomfort, tolerated well.On (b)(6) 2017, patient was having reoccurrence of pain in the right knee.Patient was also having acquired genu varum (varus deformity), lumbar spondyl, degeneration of lumbar intervertebral disc and compression fracture of at l3 of lumbar spine (unknown old or new).Patient would like to go ahead and peruse synvisc one injection into the right knee.There had been no fall and no injury.Patient had persistent pain in the lumbar spine and was treated symptomatically and mri was recommended.Patient had persistent back pain without a radicular component.Physical exam revealed no effusion or discoloration.There was pain over the medial joint line.No ligamentous instability.Range of motion was full.Neurovascular status was intact.Estimated extremities were concerned there was a negative straight leg raising test bilaterally.There was no focal neurological deficit or manual muscle testing of the muscles of lower extremity.Right knee x-ray revealed significant arthritic changes with a varus deformity and narrowing of the medical compartment as well as patellofemoral disease.Patient was treated with bupivacaine hydrochloride (marcaine) and triamcinolone acetonide (kenalog), tolerated well.It was reported that patient had degenerative changes present at all levels of the lumbar spine, had some foraminal stenosis.Patient got a degenerative grade 1 spondylolisthesis at l4-l5.On (b)(6) 2017, patient received intra-articular synvisc one injection at a dose of 6ml once (lot/batch number: 7rsl021; expiry date: 31-may-2020; indication: not reported) injection in the right knee, tolerated well.The patient developed an infection in her knee requiring hospitalization.The preliminary investigation revealed that the cause of the infection was due to contamination of the synvisc one.The patient was hospitalized on (b)(6) 2017.The patient's primary diagnosis was bacterial arthritis and other diagnosis included atrial fibrillation (irregular heartbeat), high blood pressure, high cholesterol or triglycerides, underactive thyroid.On (b)(6) 2017, at 02:07 am, patient underwent x-ray knee 3 view left and results were moderate soft tissue swelling and suprapatellar joint effusion, without definite acute bony abnormality.Moderate tricompartmental degenerative changes most pronounced in the medial compartment.The same day, at 03:00 hours, patient's body fluid culture: no growth after 5 days and gram stain results showed many wbcs, no organisms seen, anaerobic culture showed no anaerobes isolated, aerobic bacterial culture showed no growth, afb culture stain: no acid fast bacilli was seen and fungus culture, afb culture and smear was in progress.The same day, at 09:22 hours, anaerobic culture showed no anaerobes isolated, aerobic bacterial culture showed no growth, afb culture stain: no acid fast bacilli was seen, gram stain results showed many wbcs, no organisms seen and fungus culture and afb culture and smear was in progress.On (b)(6) 2017, patient was discharged.On (b)(6) 2017, pulse rate was 81 and bp was 131/69.On (b)(6) 2017, bp was 130/68.On (b)(6) 2017, pulse rate was 80 and bp was 127/79.On (b)(6) 2017, pulse rate was 82 and bp was 139/94.On (b)(6) 2017, pulse rate was 73 and bp was 146/79.On (b)(6) 2017, pulse rate was 79 and bp was 128/48.On (b)(6) 2017, pulse rate was 72 and bp was 125/64.On (b)(6) 2018, patient's vitals were blood pressure: 150/86, temperature: 99.3 f, pulse: 110, respiration: 16.Corrective treatment: triamcinolone acetonide (kenalog) and bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depo-medrol), hydrocodone, paracetamol (acetaminophen) for persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee; rivaroxaban (xarelto), rosuvastatin calcium (crestor) for underactive thyroid; not reported for rest of the events outcome: recovering/resolving for developed an infection in her knee, bacterial arthritis, developed infection , become ill, device malfunction; unknown for persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee, atrial fibrillation (irregular heartbeat), underactive thyroid, crepitation with flexion-extension of the knee, high blood pressure, high cholesterol or triglycerides an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: in-patient hospitalization for device malfunction, developed an infection in her knee, bacterial arthritis, developed infection , become ill; required intervention for persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee; important medical event for atrial fibrillation (irregular heartbeat) additional information was received on 28-feb-2018 from patient's consel.Event verbatim of developed an infection in her knee was updated to developed an infection in her knee, bacterial arthritis, developed infection , become ill, onset date was updated and outcome was updated from unknown to recovering/resolving and moderate soft tissue swelling and suprapatellar joint effusion were added as symptoms for the same.Additional events of persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee, atrial fibrillation (irregular heartbeat), device malfunction, underactive thyroid, crepitation with flexion-extension of the knee, high blood pressure and high cholesterol or triglycerides and their details were added.Therapy details of the suspect product were updated.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 28-feb-2018 : this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced bacterial arthritis and atrial fibrillation.A temporal relationship can be established with the product administration for the event of bacterial arthritis.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the event to the product cannot be excluded.The causality for atrial fibrillation has as unlikely as gthere is no pharmacological plausibility of the event occuring due to synvic.
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Manufacturer Narrative
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Lot no.And expiration date for synvisc one received on 07-mar-2017: 6rsl037a and 31-aug-2019.
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Event Description
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Developed an infection in her knee, bacterial arthritis, developed infection , become ill [arthritis bacterial] ([swelling of r knee], [joint effusion]) device malfunction [device malfunction] atrial fibrillation (irregular heartbeat) [atrial fibrillation] persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee [knee pain] underactive thyroid [thyroid function decreased] crepitation with flexion-extensiion of the knee [joint crepitation] high blood pressure [blood pressure increased] high cholesterol or triglycerides [triglyceride increased] case narrative: this case was cross referenced with case id: (b)(4).(duplicate).This unsolicited case from united states was received on 08-feb-2018 from the physician.This case concerns a 78 years old female patient who received treatment with synvisc one injection and after unknown latency had high cholesterol or triglycerides, high blood pressure, developed an infection in her knee, bacterial arthritis, developed infection, become ill, atrial fibrillation (irregular heartbeat), underactive thyroid and persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee, crepitation with flexion-extensiion of the knee.Also, device malfunction was identified for the reported lot number.Patient was allergic to eggs (egg derived), codeine (incoherent or faint), penicillins (syncope), some avain products (aches).Patient never smoked and was occasional alcohol drinker.Patient had claustrophobia.She had synvisc that was administered over 3 weeks and it did not work as well.It was reported that her arthritis just might be getting worse in the synvisc that was not working as well.Patient had knee pain (right), unilateral primary osteoarthritis of right knee, right knee joint varus deformity.On (b)(6) 2017, patient had an appointment with md.The same day, patient's physical examination of right knee revealed there was an acquired varus deformity.No effusion or discoloration of the right knee was noted.There was full extension to around 20 degree of flexion.There was no instability in flexion or extension.Patellar was stable.The same day, patient underwent right knee 3 view x-ray: an acquired varus deformity.There were degenerative changes present in the joint with narrowing of the medical compartment and some patellofemoral disease.No acute bone injury was noted.The patient was prescribed synvisc one injection into the right knee.Patient was ambulatory with walker.Concomitant medications included latanoprost, bumetanide (bumex), levothyroxine sodium (synthroid), pantoprazole sodium (protonix), ranitidine hydrochloride (zantac), diclofenac potassium (voltaren), rosuvastatin calcium (crestor), terconazole (terazol 7), rivaroxaban (xarelto).On (b)(6) 2017, patient arrived for synvisc one injection into the right knee.The patient tolerated the procedure well.The same day, physical exam: no acquired varus deformity, no effusion and discoloration of knee.There was tenderness over the medial joint line, range of motion remained the same.It was confirmed that patient did not have history of prior adverse reaction, active infections or relevant allergies.No effusion, erythema or warmth.Skin was clear.Skin was prepped with betadine.Topical anesthesia was achieved with ethyl chloride.The same day, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (indication: not reported; lot number: 6rsl037a and expiration date: 31-aug-2019).On (b)(6) 2017, patient returned to office with complaints of some persistent pain present in the right knee.She might have a little inflammatory reaction as a result of synvisc one.The same day, patient received 2 cc of bupivacaine hydrochloride (marcaine) and 40 mg of triamcinolone acetonide (kenalog) injection in the right knee joint.Patient was instructed to avoid strenuous activity for next 24-48 hours to use ice, nsaids or tylenol for pain as needed.On (b)(6) 2017, patient presented with low back pain, hip pain (right and left), inflammation of sacroiliac joint (patient was prescribed with diclofenac/voltaren 1 % topical gel, 2 g four times a day), degeneration of lumbar intervertebral disc (prescribed with oral medrol pack 4 mg tablets) and lumbar spondylosis.Physical examination revealed full range of motion the joints of the lower extremities.There was absolutely no weakness on manual muscle testing of the muscles of the lower extremity specifically the hip flexors, quadriceps, hamstring, doorsi and plantar flexors.There was no edema, discoloration lower extremity and good pulses were noted.There was tenderness to palpation of the lumbosacral junction as well as over the area the sacroiliac joint on the left.Same day, patient underwent lumbar-spine x-ray that revealed levoscoliosis.There was severe and advanced degenerative disc disease/arthritic changes present at multiple levels in the lumbar spine as well as degenerative changes seen in the facet joints.There appeared to be perhaps an old compression fracture superior end plate of l3.Patient also underwent pelvis x-ray revealed no acute bony injury.X-rays do reveal significant sclerosis along the left sacroiliac joint.X-ray revealed what appears to be some chronic irritation and inflammation of the sacroiliac joint on the left.Patient was offered physical therapy but she wanted to hold off.Patient was not having any radicular complaints and neurological examination was completely within normal limits.On (b)(6) 2017, patient presented with chronic low back pain and knee pain, lumbar spondylosis, spinal stenosis of lumbar region.Patient was not having any radicular complaints at this time and no change in bowel or bladder function.She was on anticoagulants and so could not take any nsaids.Physical examination revealed no effusion discoloration.There was mild varus deformity, full extension to about 110 degree of flexion.There was no instability.There was pain over the medial joint line.There was some crepitance with flexion-extension of the knee.Patient received 2 cc of bupivacaine hydrochloride (marcaine) and 40 mg of methylprednisolone acetate (depo-medrol) into the right knee joint, for symptomatic relief of the discomfort, tolerated well.On (b)(6) 2017, patient was having reoccurrence of pain in the right knee.Patient was also having acquired genu varum (varus deformity), lumbar spondyl, degeneration of lumbar intervertebral disc and compression fracture of at l3 of lumbar spine (unknown old or new).Patient would like to go ahead and peruse synvisc one injection into the right knee.There had been no fall and no injury.Patient had persistent pain in the lumbar spine and was treated symptomatically and mri was recommended.Patient had persistent back pain without a radicular component.Physical exam revealed no effusion or discoloration.There was pain over the medial joint line.No ligamentous instability.Range of motion was full.Neurovascular status was intact.Estimated extremities were concerned there was a negative straight leg raising test bilaterally.There was no focal neurological deficit or manual muscle testing of the muscles of lower extremity.Right knee x-ray revealed significant arthritic changes with a varus deformity and narrowing of the medical compartment as well as patellofemoral disease.Patient was treated with bupivacaine hydrochloride (marcaine) and triamcinolone acetonide (kenalog), tolerated well.It was reported that patient had degenerative changes present at all levels of the lumbar spine, had some foraminal stenosis.Patient got a degenerative grade 1 spondylolisthesis at l4-l5.On (b)(6) 2017, patient received intra-articular synvisc one injection at a dose of 6ml once (lot/batch number: 7rsl021; expiry date: 31-may-2020; indication: not reported) injection in the right knee, tolerated well.The patient developed an infection in her knee requiring hospitalization.The preliminary investigation revealed that the cause of the infection was due to contamination of the synvisc one.The patient was hospitalized on (b)(6) 2017.The patient's primary diagnosis was bacterial arthritis and other diagnosis included atrial fibrillation (irregular heartbeat), high blood pressure, high cholesterol or triglycerides, underactive thyroid.On (b)(6) 2017, at 02:07 am, patient underwent x-ray knee 3 view left and results were moderate soft tissue swelling and suprapatellar joint effusion, without definite acute bony abnormality.Moderate tricompartmental degenerative changes most pronounced in the medial compartment.The same day, at 03:00 hours, patient's body fluid culture: no growth after 5 days and gram stain results showed many wbcs, no organisms seen, anaerobic culture showed no anaerobes isolated, aerobic bacterial culture showed no growth, afb culture stain: no acid fast bacilli was seen and fungus culture, afb culture and smear was in progress.The same day, at 09:22 hours, anaerobic culture showed no anaerobes isolated, aerobic bacterial culture showed no growth, afb culture stain: no acid fast bacilli was seen, gram stain results showed many wbcs, no organisms seen and fungus culture and afb culture and smear was in progress.On (b)(6) 2017, patient was discharged.On (b)(6) 2017, pulse rate was 81 and bp was 131/69.On (b)(6) 2017, bp was 130/68.On (b)(6) 29-nov-2017, pulse rate was 80 and bp was 127/79.On 30-nov-2017, pulse rate was 82 and bp was 139/94.On(b)(6) 2017, pulse rate was 73 and bp was 146/79.On (b)(6) 2017, pulse rate was 79 and bp was 128/48.On (b)(6) 2017, pulse rate was 72 and bp was 125/64.On (b)(6) 2018, patient's vitals were blood pressure: 150/86, temperature: 99.3 f, pulse: 110, respiration: 16.Corrective treatment: triamcinolone acetonide (kenalog) and bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depo-medrol), hydrocodone, paracetamol (acetaminophen) for persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee; rivaroxaban (xarelto), rosuvastatin calcium (crestor) for underactive thyroid; not reported for rest of the events outcome: recovering/resolving for developed an infection in her knee, bacterial arthritis, developed infection , become ill, device malfunction; unknown for persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee, atrial fibrillation (irregular heartbeat), underactive thyroid, crepitation with flexion-extension of the knee, high blood pressure, high cholesterol or triglycerides a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 52593 an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: in-patient hospitalization for device malfunction, developed an infection in her knee, bacterial arthritis, developed infection , become ill; required intervention for persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee; medically significant events of atrial fibrillation (irregular heartbeat) and for device malfunction.Additional information was received on 28-feb-2018 from patient's counsel.Event verbatim of developed an infection in her knee was updated to developed an infection in her knee, bacterial arthritis, developed infection , become ill, onset date was updated and outcome was updated from unknown to recovering/resolving and moderate soft tissue swelling and suprapatellar joint effusion were added as symptoms for the same.Additional events of persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee, atrial fibrillation (irregular heartbeat), device malfunction, underactive thyroid, crepitation with flexion-extension of the knee, high blood pressure and high cholesterol or triglycerides and their details were added.Therapy details of the suspect product were updated.Clinical course was updated and text amended accordingly.Follow up information was received on 06-mar-2018.Global ptc number was added.Follow up information was received on 06-mar-2018 and 15-mar-2018 processed together with clock start date 06-mar-2018.No new information received.Follow up information was received on 15-oct-2018 from a lawyer.Verbatim of symptom suprapatellar joint effusion updated to suprapatellar joint effusion/ fluid build up.No significant information received.
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Event Description
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Developed an infection in her knee, bacterial arthritis, developed infection , become ill [arthritis bacterial] ([swelling of r knee], [joint effusion], [device malfunction], [difficulty in standing], [burning sensation]) knee pain was more severe and disabling than before [disability nos] atrial fibrillation (irregular heartbeat) [atrial fibrillation] underactive thyroid [thyroid function decreased] crepitation with flexion-extensiion of the knee/crepitus [joint crepitation] high blood pressure [blood pressure increased] high cholesterol or triglycerides [triglyceride increased] right knee range of motion restricted [joint range of motion decreased] trouble waking with her right knee [difficulty in walking] pain is sharp with sitting, standing and walking [pain upon movement] persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee/pain all the time/severe pain [knee pain] could not walk/cannot move/ could not sit [unable to walk].Case narrative: this case was cross referenced with case id: (b)(4).This unsolicited legal case from united states was received on 08-feb-2018 from the physician.This case concerns a 78 years old female patient who received treatment with synvisc one injection and after unknown latency had high cholesterol or triglycerides, high blood pressure, developed an infection in her knee, bacterial arthritis, developed infection, become ill, atrial fibrillation (irregular heartbeat), underactive thyroid and persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee/severe pain, crepitation with flexion-extensiion of the knee/ crepitus, joint range of motion restricted, trouble walking with her right knee, pain more severe and disabling than before and pain is sharp with sitting, standing and walking.Also, device malfunction was identified for the reported lot number.Patient was allergic to eggs (egg derived), codeine (incoherent or faint), penicillins (syncope), some avain products (aches).Patient never smoked and was occasional alcohol drinker.Patient had claustrophobia.She had synvisc that was administered over 3 weeks and it did not work as well.It was reported that her arthritis just might be getting worse in the synvisc that was not working as well.Patient had knee pain (right), unilateral primary osteoarthritis of right knee, right knee joint varus deformity.On 24-feb-2017, patient had an appointment with md.The same day, patient's physical examination of right knee revealed there was an acquired varus deformity.No effusion or discoloration of the right knee was noted.There was full extension to around 20 degree of flexion.There was no instability in flexion or extension.Patellar was stable.The same day, patient underwent right knee 3 view x-ray: an acquired varus deformity.There were degenerative changes present in the joint with narrowing of the medical compartment and some patellofemoral disease.No acute bone injury was noted.The patient was prescribed synvisc one injection into the right knee.Patient was ambulatory with walker.Concomitant medications included latanoprost, bumetanide (bumex), levothyroxine sodium (synthroid), pantoprazole sodium (protonix), ranitidine hydrochloride (zantac), diclofenac potassium (voltaren), rosuvastatin calcium (crestor), terconazole (terazol 7), rivaroxaban (xarelto).On (b)(6) 2017, patient arrived for synvisc one injection into the right knee.The patient tolerated the procedure well.The same day, physical exam: no acquired varus deformity, no effusion and discoloration of knee.There was tenderness over the medial joint line, range of motion remained the same.It was confirmed that patient did not have history of prior adverse reaction, active infections or relevant allergies.No effusion, erythema or warmth.Skin was clear.Skin was prepped with betadine.Topical anesthesia was achieved with ethyl chloride.The same day, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (indication: not reported; lot number: 6rsl037a and expiration date: 31-aug-2019).On (b)(6) 2017, patient returned to office with complaints of some persistent pain present in the right knee.She might have a little inflammatory reaction as a result of synvisc one.The same day, patient received 2 cc of bupivacaine hydrochloride (marcaine) and 40 mg of triamcinolone acetonide (kenalog) injection in the right knee joint.Patient was instructed to avoid strenuous activity for next 24-48 hours to use ice, nsaids or tylenol for pain as needed.On (b)(6) 2017, patient presented with low back pain, hip pain (right and left), inflammation of sacroiliac joint (patient was prescribed with diclofenac/voltaren 1 % topical gel, 2 g four times a day), degeneration of lumbar intervertebral disc (prescribed with oral medrol pack 4 mg tablets) and lumbar spondylosis.Physical examination revealed full range of motion the joints of the lower extremities.There was absolutely no weakness on manual muscle testing of the muscles of the lower extremity specifically the hip flexors, quadriceps, hamstring, doorsi and plantar flexors.There was no edema, discoloration lower extremity and good pulses were noted.There was tenderness to palpation of the lumbosacral junction as well as over the area the sacroiliac joint on the left.Same day, patient underwent lumbar-spine x-ray that revealed levoscoliosis.There was severe and advanced degenerative disc disease/arthritic changes present at multiple levels in the lumbar spine as well as degenerative changes seen in the facet joints.There appeared to be perhaps an old compression fracture superior end plate of l3.Patient also underwent pelvis x-ray revealed no acute bony injury.X-rays do reveal significant sclerosis along the left sacroiliac joint.X-ray revealed what appears to be some chronic irritation and inflammation of the sacroiliac joint on the left.Patient was offered physical therapy but she wanted to hold off.Patient was not having any radicular complaints and neurological examination was completely within normal limits.On (b)(6) 2017, patient presented with chronic low back pain and knee pain, lumbar spondylosis, spinal stenosis of lumbar region.Patient was not having any radicular complaints at this time and no change in bowel or bladder function.She was on anticoagulants and so could not take any nsaids.Physical examination revealed no effusion discoloration.There was mild varus deformity, full extension to about 110 degree of flexion.There was no instability.There was pain over the medial joint line.There was some crepitance with flexion-extension of the knee.Patient received 2 cc of bupivacaine hydrochloride (marcaine) and 40 mg of methylprednisolone acetate (depo-medrol) into the right knee joint, for symptomatic relief of the discomfort, tolerated well.On (b)(6) 2017, patient was having reoccurrence of pain in the right knee.Patient was also having acquired genu varum (varus deformity), lumbar spondyl, degeneration of lumbar intervertebral disc and compression fracture of at l3 of lumbar spine (unknown old or new).Patient would like to go ahead and peruse synvisc one injection into the right knee.There had been no fall and no injury.Patient had persistent pain in the lumbar spine and was treated symptomatically and mri was recommended.Patient had persistent back pain without a radicular component.Physical exam revealed no effusion or discoloration.There was pain over the medial joint line.No ligamentous instability.Range of motion was full.Neurovascular status was intact.Estimated extremities were concerned there was a negative straight leg raising test bilaterally.There was no focal neurological deficit or manual muscle testing of the muscles of lower extremity.Right knee x-ray revealed significant arthritic changes with a varus deformity and narrowing of the medical compartment as well as patellofemoral disease.Patient was treated with bupivacaine hydrochloride (marcaine) and triamcinolone acetonide (kenalog), tolerated well.It was reported that patient had degenerative changes present at all levels of the lumbar spine, had some foraminal stenosis.Patient got a degenerative grade 1 spondylolisthesis at l4-l5.On (b)(6) 2017, patient received intra-articular synvisc one injection at a dose of 6ml once (lot/batch number: 7rsl021; expiry date: 31-may-2020; indication: not reported) injection in the right knee, tolerated well.The patient developed an infection in her knee requiring hospitalization.The preliminary investigation revealed that the cause of the infection was due to contamination of the synvisc one.The day she had injected in her right knee she could not sit, stand, or walk and was in severe pain.On an unknown date, the patient stated that she walked with a walker and did not before the last synvisc injection and had pain all the time.The pain was sharp with sitting, standing, and walking (latency: unknown) and had burning sensation in her right knee intermittently.She had trouble walking with her right knee.The patient was hospitalized on (b)(6) 2017.The patient's primary diagnosis was bacterial arthritis and other diagnosis included atrial fibrillation (irregular heartbeat), high blood pressure, high cholesterol or triglycerides, underactive thyroid.On (b)(6) 2017, at 02:07 am, patient underwent x-ray knee 3 view left and results were moderate soft tissue swelling and suprapatellar joint effusion, without definite acute bony abnormality.Moderate tricompartmental degenerative changes most pronounced in the medial compartment.The same day, at 03:00 hours, patient's body fluid culture: no growth after 5 days and gram stain results showed many wbcs, no organisms seen, anaerobic culture showed no anaerobes isolated, aerobic bacterial culture showed no growth, afb culture stain: no acid fast bacilli was seen and fungus culture, afb culture and smear was in progress.The same day, at 09:22 hours, anaerobic culture showed no anaerobes isolated, aerobic bacterial culture showed no growth, afb culture stain: no acid fast bacilli was seen, gram stain results showed many wbcs, no organisms seen and fungus culture and afb culture and smear was in progress.On (b)(6) -2017, patient was discharged.On (b)(6) 2017, pulse rate was 81 and bp was 131/69.On (b)(6) 2017, bp was 130/68.On (b)(6) 2017, pulse rate was 80 and bp was 127/79.On (b)(6) 2017, pulse rate was 82 and bp was 139/94.On (b)(6) 2017, pulse rate was 73 and bp was 146/79.On (b)(6) 2017, pulse rate was 79 and bp was 128/48.On (b)(6) 2017, pulse rate was 72 and bp was 125/64.On (b)(6) 2018, patient's vitals were blood pressure: 150/86, temperature: 99.3 f, pulse: 110, respiration: 16, x-ray showed there was tricompartmental osteoarthritis with joint space narrowing, osteophytes and subchondrai sclerosis.On (b)(6) 2018, patient reported for follow up for pain in right knee.Patient reported that after receiving the injection, her knee pain was more severe and disabling than before (latency: unknown) and she had trouble waking with her right knee (latency: unknown).She further mentioned that she had been to the physiotherapist but it did not help her at all.Corrective treatment: norco, triamcinolone acetonide (kenalog) and bupivacaine hydrochloride (marcaine), methylprednisolone acetate (depo-medrol), hydrocodone, paracetamol (acetaminophen) for persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee; rivaroxaban (xarelto), rosuvastatin calcium (crestor) for underactive thyroid; not reported for rest of the events outcome: recovering/resolving for developed an infection in her knee, bacterial arthritis, developed infection , become ill, device malfunction; unknown for trouble walking with her right knee, pain more severe and disabling than before and pain is sharp with sitting, standing and walking, persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee, atrial fibrillation (irregular heartbeat), underactive thyroid, crepitation with flexion-extension of the knee/ crepitus, high blood pressure, high cholesterol or triglycerides.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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: in-patient hospitalization, intervention required, medically significant, disability for pain more severe and disabling than before, developed an infection in her knee, bacterial arthritis, developed infection, become ill; medically significant for atrial fibrillation (irregular heartbeat).Additional information was received on 28-feb-2018 from patient's counsel.Event verbatim of developed an infection in her knee was updated to developed an infection in her knee, bacterial arthritis, developed infection , become ill, onset date was updated and outcome was updated from unknown to recovering/resolving and moderate soft tissue swelling and suprapatellar joint effusion were added as symptoms for the same.Additional events of persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee, atrial fibrillation (irregular heartbeat), device malfunction, underactive thyroid, crepitation with flexion-extension of the knee, high blood pressure and high cholesterol or triglycerides and their details were added.Therapy details of the suspect product were updated.Clinical course was updated and text amended accordingly.Follow up information was received on 06-mar-2018.Global ptc number was added.Follow up information was received on 06-mar-2018 and 15-mar-2018 processed together with clock start date 06-mar-2018.No new information received.Follow up information was received on 15-oct-2018 from a lawyer.Verbatim of symptom suprapatellar joint effusion updated to suprapatellar joint effusion/ fluid build up.No significant information received.Upon internal review on (b)(6) 2018, case (b)(4) was found to be duplicate of this case.Hence related case id was added.Additional information was received on 14-jan-2019 from a lawyer.Symptom added for cannot move/ could not sit/ could not walk and could not stand and event of joint range of motion decreased.Seriousness criteria updated.Arthralgia updated as symptom of event developed an infection in her knee, bacterial arthritis, developed infection, become ill (arthritis bacterial).Verbatim updated for the event of crepitation with flexion-extensiion of the knee/crepitus.Lab added.Clinical course was updated and text amended accordingly.Additional information received on 25-jan-2019 from lawyer.Event of trouble walking with her right knee, pain more severe and disabling than before and pain is sharp with sitting, standing and walking added.Verbatim updated from persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee/pain all the time to persistent pain in the right knee, discomfort, pain over the medial joint line, recurrence of pain in the right knee/pain all the time/severe pain; corrective treatment of norco added.Clinical course updated.Text amended accordingly.
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