| 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
Muscle Spasm(s) (1966); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Anxiety (2328); Hypoesthesia (2352); Arthralgia (2355); No Code Available (3191)
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| Event Date 11/22/2017 |
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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 19-dec-2017 from the patient.This case concerns (b)(6) year old female patient who received treatment with synvisc one injection and the same day patient was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker, couldn't bend or do anything, even lying down in bed it hurt/ pain and after unknown latency it really had been horrible (unevaluable event).No relevant medical history and concurrent condition was reported.Patient received the five injections at one time followed by three (about 15 years ago).Patient also received the synvisc-one two years ago.Patient denied having any prosthetic devices and any previous or concomitant treatment with immunosuppressants.Patient didn't know what an immunosuppressant was.Patient stated that she doesn't drink or smoke.Patient stated that she was not allergic to avian proteins, feathers, or eggs.On an unknown date (before (b)(6)), the patient received treatment with intraarticular synvisc one injection (dose, indication, frequency, lot number and expiration date: not reported)in both the knees.Patient has been on a walker for over a month and she was in bed a week after she received the injection in both knees because she could not walk.Patient stated that she had to miss thanksgiving.Patient stated that it "really had been horrible".When patient was asked the reason for her getting the injections in the knees and if it was for osteoarthritis she said that she "guesses so".Patient stated that she was seeing her physician every week since this happened and he gave patient the paperwork about the recall.When asked what the md had done since she received the synvisc, one patient stated that she would not let him touch her because patient was so nervous.Patient states that yesterday he "took out blood or liquid" out of the knee and sent it to the lab.When patient was asked when the pain started she said it started the same night she received the injection and patient couldn't even walk with a walker (latency: 0 day).Patient stated that she couldn't bend or do anything and that even lying down in bed it hurt (latency: 0 day).Patient stated that before she received the synvisc one she was walking fine.Patient states that she shouldn't have done it and that she "didn't need anything".Patient stated that she did not had a fever.When patient was asked if she was engaged in activities such as jogging or tennis soon after she received the synvisc-one patient laughed and said patient went to bed.Patient stated that she was in overall good health before she received the synvisc-one.Patient then stated that she should have gone to the doctor sooner but she couldn't walk and then when she went to get an mri her car broke down and then patient stated that she didn't get to the md until (b)(6) 2017.Patient stated that she was better and that she was able to walk a little around the house without a walker but she was still using a walker.Patient stated that her back has started up now because she was leaning on the walker.Patient states that this was the first time in the life that this had happened.Corrective treatment: walker for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker; paracetamol for even lying down in bed it hurt/ pain; not reported for rest outcome: unknown for all a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: disability for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker pharmacovigilance comment: sanofi company comment dated 26-dec-2017: this case concerns a patient who received treatment with synvisc one injection and later experienced to being unable to walk, mobility decreased and knee pain.Based on the available information, temporal relationship can be established between the events and the suspect product.However, information regarding injected lot number, injection technique used, past drugs, concomitant medications and other risk factors is required for further case assessment.Additionally, patient's underlying condition of osteoarthritis and advancing age might be the confounding factor in the occurrence of events.
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Event Description
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This unsolicited case from united states was received on 19-dec-2017 from the patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and the same day patient was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker, couldn't bend or do anything, even lying down in bed it hurt/ pain and after unknown latency it really had been horrible (unevaluable event).No relevant medical history and concurrent condition was reported.Patient received the five injections at one time followed by three (about 15 years ago).Patient also received the synvisc-one two years ago.Patient denied having any prosthetic devices and any previous or concomitant treatment with immunosuppressants.Patient didn't know what an immunosuppressant was.Patient stated that she doesn't drink or smoke.Patient stated that she was not allergic to avian proteins, feathers, or eggs.On an unknown date ((b)(6)), the patient received treatment with intraarticular synvisc one injection (dose, indication, frequency, lot number and expiration date: not reported) in both the knees.Patient has been on a walker for over a month and she was in bed a week after she received the injection in both knees because she could not walk.Patient stated that she had to miss (b)(6).Patient stated that it "really had been horrible".When patient was asked the reason for her getting the injections in the knees and if it was for osteoarthritis she said that she "guesses so".Patient stated that she was seeing her physician every week since this happened and he gave patient the paperwork about the recall.When asked what the md had done since she received the synvisc one patient stated that she would not let him touch her because patient was so nervous.Patient states that yesterday he "took out blood or liquid" out of the knee and sent it to the lab.When patient was asked when the pain started she said it started the same night she received the injection and patient couldn't even walk with a walker (latency: 0 day).Patient stated that she couldn't bend or do anything and that even lying down in bed it hurt (latency: 0 day).Patient stated that before she received the synvisc one she was walking fine.Patient states that she shouldn't have done it and that she "didn't need anything".Patient stated that she did not had a fever.When patient was asked if she was engaged in activities such as jogging or tennis soon after she received the synvisc-one patient laughed and said patient went to bed.Patient stated that she was in overall good health before she received the synvisc-one.Patient then stated that she should have gone to the doctor sooner but she couldn't walk and then when she went to get an mri her car broke down and then patient stated that she didn't get to the md until (b)(6) 2017.Patient stated that she was better and that she was able to walk a little around the house without a walker but she was still using a walker.Patient stated that her back has started up now because she was leaning on the walker.Patient states that this was the first time in the life that this had happened.Corrective treatment: walker for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker; paracetamol for even lying down in bed it hurt/ pain; not reported for rest outcome: unknown for all a pharmaceutical technical complaint (ptc) was initiated with ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker additional information was received on 29-dec-2017.The global ptc number with ptc result was added.Text was amended accordingly.Pharmacovigilance comment: sanofi company follow up comment dated 29-dec-2017: the follow up information received does not change the prior case assessment.This case concerns a patient who received treatment with synvisc one injection and later experienced to being unable to walk, mobility decreased and knee pain.Based on the available information, temporal relationship can be established between the events and the suspect product.However, information regarding injected lot number, injection technique used, past drugs, concomitant medications and other risk factors is required for further case assessment.Additionally, patient's underlying condition of osteoarthritis and advancing age might be the confounding factor in the occurrence of events.
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Event Description
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This unsolicited case from united states was received on 19-dec-2017 from the patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and the same day patient was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk, couldn't bend or do anything/in bed for 2 days, even lying down in bed it hurt/ pain/terrible pain and after unknown latency it really had been horrible (unevaluable event).No relevant medical history was reported.Patient received the five injections at one time followed by three (about 15 years ago).Patient also received the synvisc-one two years ago.Patient denied having any prosthetic devices and any previous or concomitant treatment with immunosuppressants.Patient didn't know what an immunosuppressant was.Patient stated that she doesn't drink or smoke.Patient stated that she was not allergic to avian proteins, feathers, or eggs.Patient had allergy to codeine- dizzy and fainted.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection once (dose, indication, lot number and expiration date: not reported) in both the knees.On the same day, after the injection, patient has been on a walker for over a month and she was in bed a week after she received the injection in both knees because she could not walk.Patient stated that she had to miss thanksgiving.Patient stated that it "really had been horrible".When patient was asked the reason for her getting the injections in the knees and if it was for osteoarthritis she said that she "guesses so".Patient stated that she was seeing her physician every week since this happened and he gave patient the paperwork about the recall.When asked what the md had done since she received the synvisc one patient stated that she would not let him touch her because patient was so nervous.Patient states that yesterday he "took out blood or liquid" out of the knee and sent it to the lab.When patient was asked when the pain started she said it started the same night she received the injection and patient couldn't even walk with a walker (latency: 0 day).It was reported that patient had terrible pain, unable to walk, patient was in bed for 2 days.Patient stated that she couldn't bend or do anything and that even lying down in bed it hurt (latency: 0 day).Patient stated that before she received the synvisc one she was walking fine.Patient states that she shouldn't have done it and that she "didn't need anything".Patient stated that she did not had a fever.When patient was asked if she was engaged in activities such as jogging or tennis soon after she received the synvisc-one patient laughed and said patient went to bed.Patient stated that she was in overall good health before she received the synvisc-one.Patient then stated that she should have gone to the doctor sooner but she couldn't walk and then when she went to get an mri her car broke down and then patient stated that she didn't get to the md until (b)(6) 2017.Patient stated that she was better and that she was able to walk a little around the house without a walker but she was still using a walker.Patient stated that her back has started up now because she was leaning on the walker.Patient states that this was the first time in the life that this had happened.Corrective treatment: walker for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk; none for couldn't bend or do anything/in bed for 2 days; paracetamol for even lying down in bed it hurt/ pain/terrible pain; not reported for really has been horrible outcome: unknown for really has been horrible; not recovered for even lying down in bed it hurt/ pain/terrible pain and couldn't bend or do anything/in bed for 2 days; recovering for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk a pharmaceutical technical complaint (ptc) was initiated with ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk additional information was received on 29-dec-2017.The global ptc number with ptc result was added.Text was amended accordingly.Additional information was received on 06-feb-2018 from patient.Verbatim was updated for the event of she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker to she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk; event lying down in bed it hurt/ pain to event lying down in bed it hurt/ pain/terrible pain.Product start date updated.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company follow up comment dated 6-feb-2018: the follow up information received does not change the prior case assessment.This case concerns a patient who received treatment with synvisc one injection and later experienced to being unable to walk, mobility decreased and knee pain.Based on the available information, temporal relationship can be established between the events and the suspect product.However, information regarding injected lot number, injection technique used, past drugs, concomitant medications and other risk factors is required for further case assessment.Additionally, patient's underlying condition of osteoarthritis and advancing age might be the confounding factor in the occurrence of events.
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Event Description
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This unsolicited case from united states was received on (b)(6) 2017 from the patient.This case concerns a 89 year old female patient who received treatment with synvisc one injection and the same day patient was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk, couldn't bend or do anything/in bed for 2 days, even lying down in bed it hurt/ pain/terrible pain and after unknown latency it really had been horrible (unevaluable event) and back pain, neutrophil percentage increased and synovial fluid cloudy.Patient received the five injections at one time followed by three (about 15 years ago).Patient's concomitant medications included levothyroxine sodium, hydrochlorothiazide, ceftazidime (fortaz) and clonidine hydrochloride.Patient also received the synvisc-one two years ago.Patient denied having any prosthetic devices and any previous or concomitant treatment with immunosuppressants.Patient didn't know what an immunosuppressant was.Patient stated that she doesn't drink or smoke.Patient stated that she was not allergic to avian proteins, feathers, or eggs.Patient had allergy to codeine- dizzy and fainted, allergy to adhesive tape, latex allergy, skin cancer, hypertension, cataract, arthritis, cardiac disease, hypothyroidism, kidney disorder, right knee arthroscopy, right shoulder surgery, right carpal tunnel surgery, right carpal tunnel surgery and left arm surgery.Patient was a non smoker and abstains from drugs and alcohol.Patient denies any medical history of brain ca, colon ca, lung ca, pancreatic ca, breast ca, ovarian ca, stomach ca, liver ca, cancerous growth/tumor/cyst, chemotherapy, other ca, stroke, hearing impaired, other ent problems, dysplastic moles, skin disease, osteoporosis, chronic back pain, development/growth disorders, other msk problems, diabetes, autoimmune disorders, endocrine disorders, gerd, esophagitis, hiatal hernia, diverticulitis, diverticulosis, ulcerative colitis, gastric ulcer, gi bleed, colon polyp, gallbladder problems, other gi problems, gu problems, gyn problems, asthma, chronic lung disease, tuberculosis, respiratory disease, epilepsy, chronic headaches, neurological disorders, depression, suicide attempts, psychiatric illness, anemia, bleeding disease, blood transfusion.Patient denies any surgical history of cardiovascular surgery, valvular surgery, peripheral vascular surgery, ent surgery, eye surgery, sinus surgery, septoplasty, lung surgery, cervical laminectomy, lumbar laminectomy, back surgery, shoulder surgery, foot surgery, knee surgery, gi surgery, ulcer surgery, appendectomy, colectomy, cholecystectomy, hernia surgery, hemorrhoidectomy, gu surgery, renal surgery, gyn surgery, uterine surgery, lumpectomy, mastectomy, hysterectomy, ovary removal, tubal ligation, neurologic surgery, thyroid surgery, hematologic-oncologic surgery.Patient had a history of back pain for years which actually had improved since about 2008.She had received injections but not since 2007 when the back pain actually improved.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection once (dose, indication, lot number and expiration date: not reported) in both the knees.Flexor and extensor tendon complexes were intact.Patellofemoral arthropathy.Caitilage flap patellar apex approximately 5mm.Intermediate to high grade chondromalacia central trochlea.Subchondral osteophyte.Hypertrophic suprapatellar plica.Chronic medial meniscus tear.Small remnant extruded.Mcl intact.Severe medial compartment arthrosis.Osteophytes.Remodeled articular surfaces.Cartilage delamination.Mild subchondral marrow reaction.Undersurface and free edge tear posterior horn, body and anterior horn lateral meniscus.Lcl intact.Mild lateral compartment arthrosis.Osteophytes.Intermediate grade chondromalacia.Chronic complete acl tear.Pcl intact and buckled.Moderate complex effusion.Debris within the capsule and popliteus reflection.Ruptured small baker's cyst.Due to the patient's failure and limited relief in response to the non-invasive treatment such as rest, ice, heat, activity modification and anti-inflammatory medications, the injection is medically reasonable and necessary to manage pain, which was performed by the providing physician.This injection will help relieve pain and improve function as well as decrease inflammation to the affected area.The site to be injected was prepped.The area of chief complaint was scanned using a 15-6 mhz probe.Views were taken in both the longitudinal and transverse planes.The affected area was scanned concentrating on the structures.Ultrasound examination reveals inflammation.This was easily seen in both the longitudinal and transverse scans.A needle filled with the solution noted was introduced into the site using a guided ultrasound throughout the procedure in order to evaluate accurate and appropriate needle placement in the structure.Needle guided ultasound was utilized to visualize the site and structures to be injected and treated which revealed edema and inflammation.The solution was injected slowly and meticulously into the area.The painful site was fully infiltrated.Following the injection, pressure was maintained at the site for approximately one minute.The patient was given instructions on post injection care and expectations and was warned of the possibility of steroidal flare post injection.The patient tolerated the procedure well.On the same day, after the injection, patient has been on a walker for over a month and she was in bed a week after she received the injection in both knees because she could not walk.Patient stated that she had to miss thanksgiving.Patient stated that it "really had been horrible".When patient was asked the reason for her getting the injections in the knees and if it was for osteoarthritis she said that she "guesses so".Patient stated that she was seeing her physician every week since this happened and he gave patient the paperwork about the recall.When asked what the md had done since she received the synvisc one patient stated that she would not let him touch her because patient was so nervous.Patient states that yesterday he "took out blood or liquid" out of the knee and sent it to the lab.When patient was asked when the pain started she said it started the same night she received the injection and patient couldn't even walk with a walker (latency: 0 day).It was reported that patient had terrible pain, unable to walk, patient was in bed for 2 days.Patient stated that she couldn't bend or do anything and that even lying down in bed it hurt (latency: 0 day).Patient stated that before she received the synvisc one she was walking fine.Patient states that she shouldn't have done it and that she "didn't need anything".Patient stated that she did not had a fever.When patient was asked if she was engaged in activities such as jogging or tennis soon after she received the synvisc-one patient laughed and said patient went to bed.Patient stated that she was in overall good health before she received the synvisc-one.Patient then stated that she should have gone to the doctor sooner but she couldn't walk and then when she went to get an mri her car broke down and then patient stated that she didn't get to the md until on(b)(6) 2017.Patient stated that she was better and that she was able to walk a little around the house without a walker but she was still using a walker.Patient stated that her back has started up now because she was leaning on the walker.Patient states that this was the first time in the life that this had happened.Patient ambulates with moderate to severe pain at any discharge with limp.Pain was severe with full knee range of motion, with knee passive range of motion.Patient denied pain in calf and thigh with hip interna/ external rotation.On an unknown date, after unknown latency, patient had back pain.She was now getting right sided back/buttock and into the right hamstring area, she had pain with arising and walking, and walking up steps.She also gets pain with lifting/carrying objects such as groceries.Corrective treatment: walker for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk; none for couldn't bend or do anything/in bed for 2 days; paracetamol for even lying down in bed it hurt/ pain/terrible pain; not reported for really has been horrible and back pain outcome: unknown for synovial fluid cloudy, neutrophil percentage increased, back pain, really has been horrible; not recovered for even lying down in bed it hurt/ pain/terrible pain and couldn't bend or do anything/in bed for 2 days; recovering for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk a pharmaceutical technical complaint (ptc) was initiated with ptc number: 51473.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk additional information was received on 29-dec-2017.The global ptc number with ptc result was added.Text was amended accordingly.Additional information was received on (b)(6) 2018 from patient.Additional event of back pain was added.Updated for the event of she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker to she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk; event lying down in bed it hurt/ pain to event lying down in bed it hurt/ pain/terrible pain.Product start date updated.Medical history and concomitant medications added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company follow up comment dated 6-feb-2018: the follow up information received does not change the prior case assessment.This case concerns a patient who received treatment with synvisc one injection and later experienced to being unable to walk, mobility decreased and knee pain.Based on the available information, temporal relationship can be established between the events and the suspect product.However, information regarding injected lot number, injection technique used, past drugs, concomitant medications and other risk factors is required for further case assessment.Additionally, patient's underlying condition of osteoarthritis and advancing age might be the confounding factor in the occurrence of events.
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Event Description
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She was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk/having trouble walking/slowed and stooped [unable to walk].Device malfunction [device malfunction].Lumbago with sciatica, right side/left side [sciatica] ([muscle weakness], [back pain], [lumbar radiculopathy], [muscle spasm]).Arthrocentesis aspiration [joint effusion].Neutrophil percentage increased [neutrophil percentage increased].Synovial fluid cloudy [synovial fluid analysis abnormal].Couldn't bend or do anything/in bed for 2 days [mobility decreased].Anxious [anxiety].Hypoesthesia in bilateral l4 distribution [hypoesthesia].Pain is exacerbated with walking [pain aggravated].Radiculopathy symptoms are affecting her adls and functional status [activities of daily living impaired].Decreased rom with back flexion and lateral flexion [joint range of motion decreased] hip bursitis [hip bursitis].Pain is present in the groin [groin pain].Neuropathic pain [neuropathic pain].Complex capsulosynovitis [synovitis].Really has been horrible [unevaluable event].Even lying down in bed it hurt/ pain/terrible pain/bilateral knee pain/ continued bilateral knee pain/pain in left and right hip/tenderness to palpitation in right hip [knee pain].Case narrative: this unsolicited case from united states was received on 19-dec-2017 from the patient.This case concerns a 89 year old female patient who received treatment with synvisc one injection and the same day she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk/having trouble walking/slowed and stooped, couldn't bend or do anything/in bed for 2 days, and after unknown latency it really had been horrible (unevaluable event) and neutrophil percentage increased, synovial fluid cloudy, pain is present in the groin, hypoesthesia in bilateral l4 distribution, arthrocentesis aspiration, anxious, pain radiated to her lower extremities, no further than the knees/pain in thigh, complex capsulosynovitis, lumbago with sciatica, right side/left side, neuropathic pain, hip bursitis, decreased rom with back flexion and lateral flexion, radiculopathy symptoms are affecting her adls and functional status, pain is exacerbated with walking (latency: unknown).A device malfunction was noted in the reported lot number.Patient received the five injections at one time followed by three (about 15 years ago).Patient had 3 hyaluronate sodium (orthovisc) injections (2017) which had adverse effects on the right knee due to ,medication being contaminated.Patient's concomitant medications included levothyroxine sodium, hydrochlorothiazide, ceftazidime (fortaz) and clonidine hydrochloride.Patient also received the synvisc-one two years ago.Patient denied having any prosthetic devices and any previous or concomitant treatment with immunosuppressants.Patient didn't know what an immunosuppressant was.Patient stated that she doesn't drink or smoke.Patient stated that she was not allergic to avian proteins, feathers, or eggs.Patient had allergy to codeine- dizzy and fainted, allergy to adhesive tape, latex allergy, skin cancer, hypertension, cataract, arthritis, cardiac disease, hypothyroidism, kidney disorder, right knee arthroscopy, right shoulder surgery, right carpal tunnel surgery, right carpal tunnel surgery and left arm surgery.Medical history included chronic back pain, moderate to severe l4-5, l3-4 and less l2-3 spondylostenosis, spondylotic disc protrusions, facet arthropathy and ligamentum flavum thickening contribute to central canal, recess and foraminal impingement, non-lateralizing soft disc herniation, sterile reactive endplate changes l3-4, l4-5, no acute fracture.Patient was a non smoker and abstains from drugs and alcohol.Patient denies any medical history of brain ca, colon ca, lung ca, pancreatic ca, breast ca, ovarian ca, stomach ca, liver ca, cancerous growth/tumor/cyst, chemotherapy, other ca, stroke, hearing impaired, other ent problems, dysplastic moles, skin disease, osteoporosis, chronic back pain, development/growth disorders, other msk problems, diabetes, autoimmune disorders, endocrine disorders, gerd, esophagitis, hiatal hernia, diverticulitis, diverticulosis, ulcerative colitis, gastric ulcer, gi bleed, colon polyp, gallbladder problems, other gi problems, gu problems, gyn problems, asthma, chronic lung disease, tuberculosis, respiratory disease, epilepsy, chronic headaches, neurological disorders, depression, suicide attempts, psychiatric illness, anemia, bleeding disease, blood transfusion.Patient denies any surgical history of cardiovascular surgery, valvular surgery, peripheral vascular surgery, ent surgery, eye surgery, sinus surgery, septoplasty, lung surgery, cervical laminectomy, lumbar laminectomy, back surgery, shoulder surgery, foot surgery, knee surgery, gi surgery, ulcer surgery, appendectomy, colectomy, cholecystectomy, hernia surgery, hemorrhoidectomy, gu surgery, renal surgery, gyn surgery, uterine surgery, lumpectomy, mastectomy, hysterectomy, ovary removal, tubal ligation, neurologic surgery, thyroid surgery, hematologic-oncologic surgery.Patient had a history of back pain for years which actually had improved since about 2008.She had received injections but not since 2007 when the back pain actually improved.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection once (dose, indication and expiration date: not reported; lot number: 7rsl021) in both the knees.Flexor and extensor tendon complexes were intact.Patellofemoral arthropathy.Cartilage flap patellar apex approximately 5mm.Intermediate to high grade chondromalacia central trochlea.Subchondral osteophyte.Hypertrophic suprapatellar plica.Chronic medial meniscus tear.Small remnant extruded.Mcl intact.Severe medial compartment arthrosis.Osteophytes.Remodeled articular surfaces.Cartilage delamination.Mild subchondral marrow reaction.Undersurface and free edge tear posterior horn, body and anterior horn lateral meniscus.Lcl intact.Mild lateral compartment arthrosis.Osteophytes.Intermediate grade chondromalacia.Chronic complete acl tear.Pcl intact and buckled.Moderate complex effusion.Debris within the capsule and popliteus reflection.Ruptured small baker's cyst.Due to the patient's failure and limited relief in response to the non-invasive treatment such as rest, ice, heat, activity modification and anti-inflammatory medications, the injection is medically reasonable and necessary to manage pain, which was performed by the providing physician.This injection will help relieve pain and improve function as well as decrease inflammation to the affected area.The site to be injected was prepped.The area of chief complaint was scanned using a 15-6 mhz probe.Views were taken in both the longitudinal and transverse planes.The affected area was scanned concentrating on the structures.Ultrasound examination reveals inflammation.This was easily seen in both the longitudinal and transverse scans.A needle filled with the solution noted was introduced into the site using a guided ultrasound throughout the procedure in order to evaluate accurate and appropriate needle placement in the structure.Needle guided ultrasound was utilized to visualize the site and structures to be injected and treated which revealed edema and inflammation.The solution was injected slowly and meticulously into the area.The painful site was fully infiltrated.Following the injection, pressure was maintained at the site for approximately one minute.The patient was given instructions on post injection care and expectations and was warned of the possibility of steroidal flare post injection.The patient tolerated the procedure well.On the same day, after the injection, patient has been on a walker for over a month and she was in bed a week after she received the injection in both knees because she could not walk.Patient stated that she had to miss thanksgiving.Patient stated that it "really had been horrible".When patient was asked the reason for her getting the injections in the knees and if it was for osteoarthritis she said that she "guesses so".Patient stated that she was seeing her physician every week since this happened and he gave patient the paperwork about the recall.When asked what the md had done since she received the synvisc one patient stated that she would not let him touch her because patient was so nervous.Patient states that yesterday he "took out blood or liquid" out of the knee and sent it to the lab.When patient was asked when the pain started she said it started the same night she received the injection and patient couldn't even walk with a walker (latency: 0 day).It was reported that patient had terrible pain, unable to walk, patient was in bed for 2 days.Patient stated that she couldn't bend or do anything and that even lying down in bed it hurt (latency: 0 day).Patient stated that before she received the synvisc one she was walking fine.Patient states that she shouldn't have done it and that she "didn't need anything".Patient stated that she did not had a fever.When patient was asked if she was engaged in activities such as jogging or tennis soon after she received the synvisc-one patient laughed and said patient went to bed.Patient stated that she was in overall good health before she received the synvisc-one.Patient then stated that she should have gone to the doctor sooner but she couldn't walk and then when she went to get an mri her car broke down and then patient stated that she didn't get to the md until (b)(6) 2017.Patient stated that she was better and that she was able to walk a little around the house without a walker but she was still using a walker.Patient stated that her back has started up now because she was leaning on the walker.Patient states that this was the first time in the life that this had happened.Patient ambulates with moderate to severe pain at any discharge with limp.Pain was severe with full knee range of motion, with knee passive range of motion.Patient denied pain in calf and thigh with hip internal/ external rotation.On an unknown date, after unknown latency, patient had back pain.She was now getting right sided back/buttock and into the right hamstring area, she had pain with arising and walking, and walking up steps.She also gets pain with lifting/carrying objects such as groceries.On (b)(6) 2017, on visit, it was reported patient had complex capsulosynovitis (onset date and latency: unknown).On (b)(6) 2018, during visit to pain management center, patient presented with left and right hip pain, described as moderate, aching pain, radiated into her lower extremities, no further than the knees (onset date and latency: unknown).Her vitals were reported as blood pressure (bp): 110/64 mm hg, (p) pulse: 68 bpm; respiratory rate: 15 bpm, (o2 sat) o2 saturation: 95 %; pain index: 3.It was reported that pain is exacerbated with walking and is alleviated by sitting.At that time pain was 6/10 on pain scale.Patient also presented with bilateral l3 l4 radiculopathy (onset date and latency: unknown).Symptoms were affecting her adls and functional state.Patient attempted nsaids and failed.Physical therapy exercises including mckenzie, ice/heat therapy and medications for her symptoms.Patient was anxious, seemed to be in moderate pain, gait: slowed and stooped, decreased range of motion and pain with back flexion and lateral flexion, lumbar spinous interspace pain, spasm of the left and right lumbar paraspinal muscles, hypoesthesia in bilateral l4 distribution.Assessment was given as: low back pain, lumbar radiculopathy, sciatica, muscle spasm.On (b)(6) 2018, during pain management center visit, vitals were bp: 119/86 mm hg, p: 58 bpm, r: 16 bpm, o2 sat: 97% and pain index: 7.It was reported that patient failed conservative treatment, multiple medications including nsaids and other counter medications.Patient had excruciating pain which daily living activities.All aspects were suffering despite lifestyle modifications.Anxiety levels had increased greatly.Patient had pain in duration of more than 3 months and had neuropathic pain.Patient had transforaminal epidural steroid injection/selective (tfesi) nerve root block with fluoroscopic guidance and methylprednisolone acetate for sciatica.On (b)(6) 2018, during visit, patient's vitals were bp: 140/90 mm hg, p: 50 bpm, r: 16 bpm, o2 sat: 95%, pain index: 6.Patient complained of pain in right hip, pain present in groin and right thigh, present positive fadir (femoral acetabular impingement) signs and tenderness to palpitation on the right hip.Pain was exacerbated with physical activity and walking.Patient was advised to have benefits from right trochanter bursa injection.Patient had ultrasound guided right greater trochanter bursa injection and arthrocentesis aspiration was ordered an patient had triamcinolone acetonide injection.On (b)(6) 2018, on visit vitals were bp: 109/71 mm hg, p: 56 bpm, r: 18 bpm, o2 sat: 96%, pain index: 5.It was reported that patient had 60% relief from trochanter bursa injection but the pain has returned.Patient was advised to repeat right lumbar tfesi which patient deferred at the time.Patient had started physical therapy again and wanted to continue before another epidural was asked to evaluate benefit of physical therapy, continue home exercises and stretching.Corrective treatment: walker for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk/having trouble walking/slowed and stooped; none for couldn't bend or do anything/in bed for 2 days; paracetamol and trochanter bursa injection, triamcinolone acetonide for even lying down in bed it hurt/ pain/terrible pain/bilateral knee pain/ continued bilateral knee pain/pain in left and right hip; unspecified nsaids for physical therapy for bilateral l3 l4 radiculopathy; transforaminal epidural steroid injection, methylprednisolone acetate for lumbago with sciatica, right side/left side; unspecified nsaids and over counter medications for back pain/low back pain; not reported for rest; arthrocentesis for arthrocentesis aspiration.Outcome: unknown for hip bursitis, decreased rom with back flexion and lateral flexion, radiculopathy symptoms are affecting her adls and functional status, pain is exacerbated with walking neuropathic pain, pain is present in the groin, hypoesthesia in bilateral l4 distribution, arthrocentesis aspiration, anxious, pain radiated to her lower extremities, no further than the knees/pain in thigh, complex capsulosynovitis, synovial fluid cloudy, neutrophil percentage increased, really has been horrible; recovering for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk; not recovered for rest.A pharmaceutical technical complaint (ptc) was initiated with 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.Seriousness criterion: disability for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk/having trouble walking/slowed and stooped, device malfunction; intervention required for lumbago with sciatica and arthrocentesis aspiration.Additional information was received on 29-dec-2017.The global ptc number with ptc result was added.Text was amended accordingly.Additional information was received on 02-apr-2018 from patient.Additional event of back pain was added.Verbatim was updated for the event of she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker to she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk; event lying down in bed it hurt/ pain to event lying down in bed it hurt/ pain/terrible pain.Product start date updated.Medical history and concomitant medications added.Clinical course was updated and text was amended accordingly.Additional information was received on 27-apr-2018 from other non-health care professional.Additional event of device malfunction was added.Lot number updated.Clinical course was updated and text was amended accordingly.Additional information was received on 21-aug-2018 from physician.Medical history updated.Verbatim of event she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk/having trouble walking was updated to she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk/having trouble walking/slowed and stooped, events of pain is present in the groin, hypoesthesia in bilateral l4 distribution, arthrocentesis aspiration, anxious, complex capsulosynovitis, lumbago with sciatica, right side/left side, neuropathic pain were added with details.Seriousness criteria was updated.Clinical course updated.Text amended accordingly.
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Event Description
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This unsolicited case from united states was received on (b)(6) 2017 from the patient.This case concerns a 89 year old female patient who received treatment with synvisc one injection and the same day patient was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk, couldn't bend or do anything/in bed for 2 days, even lying down in bed it hurt/ pain/terrible pain and after unknown latency it really had been horrible (unevaluable event) and back pain, neutrophil percentage increased and synovial fluid cloudy.A device malfunction was noted in the reported lot number.Patient received the five injections at one time followed by three (about 15 years ago).Patient's concomitant medications included levothyroxine sodium, hydrochlorothiazide, ceftazidime (fortaz) and clonidine hydrochloride.Patient also received the synvisc-one two years ago.Patient denied having any prosthetic devices and any previous or concomitant treatment with immunosuppressants.Patient didn't know what an immunosuppressant was.Patient stated that she doesn't drink or smoke.Patient stated that she was not allergic to avian proteins, feathers, or eggs.Patient had allergy to codeine- dizzy and fainted, allergy to adhesive tape, latex allergy, skin cancer, hypertension, cataract, arthritis, cardiac disease, hypothyroidism, kidney disorder, right knee arthroscopy, right shoulder surgery, right carpal tunnel surgery, right carpal tunnel surgery and left arm surgery.Patient was a non smoker and abstains from drugs and alcohol.Patient denies any medical history of brain ca, colon ca, lung ca, pancreatic ca, breast ca, ovarian ca, stomach ca, liver ca, cancerous growth/tumor/cyst, chemotherapy, other ca, stroke, hearing impaired, other ent problems, dysplastic moles, skin disease, osteoporosis, chronic back pain, development/growth disorders, other msk problems, diabetes, autoimmune disorders, endocrine disorders, gerd, esophagitis, hiatal hernia, diverticulitis, diverticulosis, ulcerative colitis, gastric ulcer, gi bleed, colon polyp, gallbladder problems, other gi problems, gu problems, gyn problems, asthma, chronic lung disease, tuberculosis, respiratory disease, epilepsy, chronic headaches, neurological disorders, depression, suicide attempts, psychiatric illness, anemia, bleeding disease, blood transfusion.Patient denies any surgical history of cardiovascular surgery, valvular surgery, peripheral vascular surgery, ent surgery, eye surgery, sinus surgery, septoplasty, lung surgery, cervical laminectomy, lumbar laminectomy, back surgery, shoulder surgery, foot surgery, knee surgery, gi surgery, ulcer surgery, appendectomy, colectomy, cholecystectomy, hernia surgery, hemorrhoidectomy, gu surgery, renal surgery, gyn surgery, uterine surgery, lumpectomy, mastectomy, hysterectomy, ovary removal, tubal ligation, neurologic surgery, thyroid surgery, hematologic-oncologic surgery.Patient had a history of back pain for years which actually had improved since about 2008.She had received injections but not since 2007 when the back pain actually improved.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection once (dose, indication and expiration date: not reported; lot number: 7rsl021) in both the knees.Flexor and extensor tendon complexes were intact.Patellofemoral arthropathy.Caitilage flap patellar apex approximately 5mm.Intermediate to high grade chondromalacia central trochlea.Subchondral osteophyte.Hypertrophic suprapatellar plica.Chronic medial meniscus tear.Small remnant extruded.Mcl intact.Severe medial compartment arthrosis.Osteophytes.Remodeled articular surfaces.Cartilage delamination.Mild subchondral marrow reaction.Undersurface and free edge tear posterior horn, body and anterior horn lateral meniscus.Lcl intact.Mild lateral compartment arthrosis.Osteophytes.Intermediate grade chondromalacia.Chronic complete acl tear.Pcl intact and buckled.Moderate complex effusion.Debris within the capsule and popliteus reflection.Ruptured small baker's cyst.Due to the patient's failure and limited relief in response to the non-invasive treatment such as rest, ice, heat, activity modification and anti-inflammatory medications, the injection is medically reasonable and necessary to manage pain, which was performed by the providing physician.This injection will help relieve pain and improve function as well as decrease inflammation to the affected area.The site to be injected was prepped.The area of chief complaint was scanned using a 15-6 mhz probe.Views were taken in bothadhesive tape, latex allergy, skin cancer, hypertension, cataract, arthritis, cardiac disease, hypothyroidism, kidney disorder, right knee arthroscopy, right shoulder surgery, right carpal tunnel surgery, right carpal tunnel surgery and left arm surgery.Patient was a non smoker and abstains from drugs and alcohol.Patient denies any medical history of brain ca, colon ca, lung ca, pancreatic ca, breast ca, ovarian ca, stomach ca, liver ca, cancerous growth/tumor/cyst, chemotherapy, other ca, stroke, hearing impaired, other ent problems, dysplastic moles, skin disease, osteoporosis, chronic back pain, development/growth disorders, other msk problems, diabetes, autoimmune disorders, endocrine disorders, gerd, esophagitis, hiatal hernia, diverticulitis, diverticulosis, ulcerative colitis, gastric ulcer, gi bleed, colon polyp, gallbladder problems, other gi problems, gu problems, gyn problems, asthma, chronic lung disease, tuberculosis, respiratory disease, epilepsy, chronic headaches, neurological disorders, depression, suicide attempts, psychiatric illness, anemia, bleeding disease, blood transfusion.Patient denies any surgical history of cardiovascular surgery, valvular surgery, peripheral vascular surgery, ent surgery, eye surgery, sinus surgery, septoplasty, lung surgery, cervical laminectomy, lumbar laminectomy, back surgery, shoulder surgery, foot surgery, knee surgery, gi surgery, ulcer surgery, appendectomy, colectomy, cholecystectomy, hernia surgery, hemorrhoidectomy, gu surgery, renal surgery, gyn surgery, uterine surgery, lumpectomy, mastectomy, hysterectomy, ovary removal, tubal ligation, neurologic surgery, thyroid surgery, hematologic-oncologic surgery.Patient had a history of back pain for years which actually had improved since about 2008.She had received injections but not since 2007 when the back pain actually improved.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection once (dose, indication and expiration date: not reported; lot number: 7rsl021) in both the knees.Flexor and extensor tendon complexes were intact.Patellofemoral arthropathy.Caitilage flap patellar apex approximately 5mm.Intermediate to high grade chondromalacia central trochlea.Subchondral osteophyte.Hypertrophic suprapatellar plica.Chronic medial meniscus tear.Small remnant extruded.Mcl intact.Severe medial compartment arthrosis.Osteophytes.Remodeled articular surfaces.Cartilage delamination.Mild subchondral marrow reaction.Undersurface and free edge tear posterior horn, body and anterior horn lateral meniscus.Lcl intact.Mild lateral compartment arthrosis.Osteophytes.Intermediate grade chondromalacia.Chronic complete acl tear.Pcl intact and buckled.Moderate complex effusion.Debris within the capsule and popliteus reflection.Ruptured small baker's cyst.Due to the patient's failure and limited relief in response to the non-invasive treatment such as rest, ice, heat, activity modification and anti-inflammatory medications, the injection is medically reasonable and necessary to manage pain, which was performed by the providing physician.This injection will help relieve pain and improve function as well as decrease inflammation to the affected area.The site to be injected was prepped.The area of chief complaint was scanned using a 15-6 mhz probe.Views were taken in both the longitudinal and transverse planes.The affected area was scanned concentrating on the structures.Ultrasound examination reveals inflammation.This was easily seen in both the longitudinal and transverse scans.A needle filled with the solution noted was introduced into the site using a guided ultrasound throughout the procedure in order to evaluate accurate and appropriate needle placement in the structure.Needle guided ultasound was utilized to visualize the site and structures to be injected and treated which revealed edema and inflammation.The solution was injected slowly and meticulously into the area.The painful site was fully infiltrated.Following the injection, pressure was maintained at the site for approximately one minute.The patient was given instructions on post injection care and expectations and was warned of the possibility of steroidal flare post injection.The patient tolerated the procedure well.On the same day, after the injection, patient has been on a walker for over a month and she was in bed a week after she received the injection in both knees because she could not walk.Patient stated that she had to miss thanksgiving.Patient stated that it "really had been horrible".When patient was asked the reason for her getting the injections in the knees and if it was for osteoarthritis she said that she "guesses so".Patient stated that she was seeing her physician every week since this happened and he gave patient the paperwork about the recall.When asked what the md had done since she received the synvisc one patient stated that she would not let him touch her because patient was so nervous.Patient states that yesterday he "took out blood or liquid" out of the knee and sent it to the lab.When patient was asked when the pain started she said it started the same night she received the injection and patient couldn't even walk with a walker (latency: 0 day).It was reported that patient had terrible pain, unable to walk, patient was in bed for 2 days.Patient stated that she couldn't bend or do anything and that even lying down in bed it hurt (latency: 0 day).Patient stated that before she received the synvisc one she was walking fine.Patient states that she shouldn't have done it and that she "didn't need anything".Patient stated that she did not had a fever.When patient was asked if she was engaged in activities such as jogging or tennis soon after she received the synvisc-one patient laughed and said patient went to bed.Patient stated that she was in overall good health before she received the synvisc-one.Patient then stated that she should have gone to the doctor sooner but she couldn't walk and then when she went to get an mri her car broke down and then patient stated that she didn't get to the md until (b)(6) 2017.Patient stated that she was better and that she was able to walk a little around the house without a walker but she was still using a walker.Patient stated that her back has started up now because she was leaning on the walker.Patient states that this was the first time in the life that this had happened.Patient ambulates with moderate to severe pain at any discharge with limp.Pain was severe with full knee range of motion, with knee passive range of motion.Patient denied pain in calf and thigh with hip interna/ external rotation.On an unknown date, after unknown latency, patient had back pain.She was now getting right sided back/buttock and into the right hamstring area, she had pain with arising and walking, and walking up steps.She also gets pain with lifting/carrying objects such as groceries.Corrective treatment: walker for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk; none for couldn't bend or do anything/in bed for 2 days; paracetamol for even lying down in bed it hurt/ pain/terrible pain; not reported for really has been horrible and back pain outcome: unknown for synovial fluid cloudy, neutrophil percentage increased, back pain, really has been horrible; not recovered for even lying down in bed it hurt/ pain/terrible pain and couldn't bend or do anything/in bed for 2 days; recovering for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk a pharmaceutical technical complaint (ptc) was initiated with ptc number: 51473.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 criterion: disability for she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk, device malfunction additional information was received on (b)(6) 2017.The global ptc number with ptc result was added.Text was amended accordingly.Additional information was received on (b)(6) 2018 from patient.Additional event of back pain was added.Verbatim was updated for the event of she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker to she was in bed/could not walk/couldn't even walk with a walker/ leaning on the walker/unable to walk; event lying down in bed it hurt/ pain to event lying down in bed it hurt/ pain/terrible pain.Product start date updated.Medical history and concomitant medications added.Clinical course was updated and text was amended accordingly.Additional information was received on (b)(6) 2018 from other non-health care professional.Additional event of device malfunction was added.Lot number updated.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company follow up comment dated (b)(6) 2018: the follow up information received does not change the prior case assessment.This case concerns a patient who received treatment with synvisc one injection from recall lot and later experienced to being unable to walk, mobility decreased and knee pain.Based on the available information, temporal relationship can be established between the events and the suspect product.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.Additionally, patient's underlying condition of osteoarthritis and advancing age might be the confounding factor in the occurrence of events.
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Search Alerts/Recalls
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