| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Arthritis (1723); Bacterial Infection (1735); Fatigue (1849); Nausea (1970); Therapeutic Response, Decreased (2271); Discomfort (2330); Joint Disorder (2373); No Code Available (3191)
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| Event Date 11/07/2017 |
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Event Type
Injury
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Event Description
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This spontaneous case from united states was received on 23-jan-2018 from patient's husband.This case concerns a (b)(6) female patient who initiated treatment with synvisc one and after a few hours had inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now, couldn't move/couldn't get around the edge of the bed, was unable to bend the right knee/couldn't put weight on it, was screaming" with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth, had right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen, was unable to straighten out her right leg/can't straighten it/ couldn't straighten my leg; on the same day had to drag my foot when i walked with a walker, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 10 ml (frequency: not provided) for osteoarthritis and torn meniscus (batch/ lot number: 7rsl021 and expiry date: unknown).On the same day, after a few hours, patient was screaming with pain, inability to walk, unable to straighten out her right leg, right knee had swelling the size of a baseball, unable to bend the right knee.During the first week first week she used ice, elevation, slept in a low bed, and used a walker to go to the bathroom.Patient's hcp prescribed 600-800 motrin, elevation, ice, and she was wearing a molded knee brace.Patient reported that no circumference measurements had been taken of the right knee, she was unable to bare weight or walk after this injection, and had pain level of 10 after this injection, denied fever, had blood work but was not sure for what, turned wrong this weekend and hurt her knee, had not recovered from this injection.Action taken: unknown.Corrective treatment: molded knee brace, wheel chair for inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now, couldn't move/couldn't get around the edge of the bed; ice for unable to bend the right knee/couldn't put weight on it and unable to straighten out her right leg/can't straighten it/couldn't straighten my leg; ice, elevation, ibuprofen (motrin) for screaming" with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth, right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen.Outcome: not recovered for all events.Seriousness criteria: disability for device malfunction and inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now.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.Pharmacovigilance comment: sanofi company comment dated 28-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later was unable to walk and mobility decreased.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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This case is cross reference with case id: (b)(4).(cluster: patient husband).This spontaneous case from united states was received on 23-jan-2018 from patient's husband.This case concerns a 61 years old female patient who initiated treatment with synvisc one and after a few hours had inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now, couldn't move/couldn't get around the edge of the bed, unable to bend the right knee/couldn't put weight on it, was screaming" with pain/hurt her knee/worst pain/ in pain/had pain on the knee back and forth, had right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen, was unable to straighten out her right leg/can't straighten it/ couldn't straighten my leg/now her right knee will not straighten out; on the same day had to drag my foot when i walked with a walker, also, device malfunction was identified for the reported lot number, white blood cell count elevated (after unknown latency), c-reactive protein elevated (after unknown latency), "cannot sleep because (she) feels like a zombie (after unknown latency), nauseated (after unknown latency) and tired (after unknown latency) and needed to use a wheelchair (after unknown latency) and discomfort (after unknown latency).No concomitant medications and concurrent conditions were reported.The patient's medical history was significant for fluid in both ears (1 month ago) for which the patient was prescribed treatment with prednisone.The patient denied any prosthetic device or any allergy to proteins, feathers, or egg products, denied history of diabetes.The patient had past treatment with synvisc-one (injections and a couple of years prior to that she's had the synvisc 3 series injections from a different hcp; injections in the past were great and she told everyone with knee pain to get them, and now was afraid to get a synvisc-one injection again and is worried about the long term adverse effects).On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 10 ml (frequency: not provided) for osteoarthritis and torn meniscus (batch/ lot number: 7rsl021 and expiry date: unknown).It was reported that the patient had been avoiding surgery.On the same day, after a few hours, patient was screaming with pain, inability to walk, unable to straighten out her right leg, right knee had swelling the size of a baseball, unable to bend the right knee.During the first week first week she used ice, elevation, slept in a low bed, and used a walker to go to the bathroom.Patient's hcp prescribed 600-800 motrin, elevation, ice, and she was wearing a molded knee brace.Patient reported that no circumference measurements had been taken of the right knee, she was unable to bare weight or walk after this injection, and had pain level of 10 after this injection, denied fever, had blood work but was not sure for what, turned wrong this weekend and hurt her knee, had not recovered from this injection.It was reported that, patient had seen her orthopedist for follow-up assessment.She found out that she received the affected synvisc-one recall lot number product.Her follow-up bloodwork indicated that her white blood cell count and c-reactive protein (both on unknown dates, after unknown latencies) were both elevated (no laboratory values were reported).Intraarticular fluid from the affected right knee was aspirated by the orthopedist and laboratory results were "negative for any bacterial growth".On (b)(6)2018, she also received a cortisone injection which "worked a little" and later she underwent the bloodwork.She had an appointment scheduled for the second week of (b)(6) 2018.However, she would be calling the orthopedist to determine if the orthopedist would like to see her earlier.It was reported that, in the past, patient received immediate relief with synvisc-one injection(s).However, she had a much different experience after receiving the recalled synvisc-one lot number product.As mentioned in the initial ae report, she initially experienced discomfort after that injection (unknown date, after unknown latency).But by that evening, she was "screaming in pain".And "now her right knee would not straighten out".On an unknown date, after unknown latency, patient has felt nauseated and she "cannot babysit grandchildren as she cannot run around, cannot walk good because she feels tired (an unknown date, after unknown latency) and she needed to use a wheelchair".Moreover, as treatment, her orthopedist has recommended that she wear "one of two braces on (her) knee which had created problems with clothing".She does not want to gain weight (from lack of mobility).The patient was instructed to place ice on the knee.So she placed ice and also applied a cream arnica montana/boswellia serrata/eucalyptus/ilex/menthol/peppermint oil (cryoderm) to the knee, both of which have worked (even though the cream was not recommended by the orthopedist for such use).On an unknown date, after unknown latency, patient cannot sleep because she feels like a zombie.Action taken: unknown corrective treatment: molded knee brace, wheel chair for inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now, couldn't move/couldn't get around the edge of the bed; ice for u unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out; ice, elevation, ibuprofen (motrin) cortisone injection for right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen; ice, elevation, ibuprofen (motrin), arnica montana/boswellia serrata/eucalyptus/ilex/menthol/peppermint oil (cryoderm) and cortisone injection for screaming" with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth; ice and arnica montana/boswellia serrata/eucalyptus/ilex/menthol/peppermint oil (cryoderm) for unable to bend the right knee/couldn't put weight on it; not reported for "cannot sleep because (she) feels like a zombie, nauseated, discomfort, needed to use a wheelchair and tired, white blood cell count elevated, c-reactive protein elevated outcome: unknown for discomfort, needed to use a wheelchair, tired, nauseated, "cannot sleep because (she) feels like a zombie, white blood cell count elevated, c-reactive protein elevated; not recovered for rest all events seriousness criteria: disability for needed to use a wheelchair, device malfunction and inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now; required intervention for white blood cell count elevated and c-reactive protein elevated a global pharmaceutical technical complaint was initiated with ptc number: 52195 an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received on 06-feb-2018.The gptc number was added.Text was amended accordingly.Additional information was received on 28-feb-2018 from patient.Related case id added.Additional events of tired, white blood cell count elevated, c-reactive protein elevated, "cannot sleep because (she) feels like a zombie, nauseated and discomfort were added with details.Event unable to bend the right knee/couldn't put weight on it corrective treatment updated.Event verbatim updated from: unable to straighten out her right leg/can't straighten it/couldn't straighten my leg to unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out.Clinical course updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 28-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later was unable to walk,mobility decreased and is wheelchair user.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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Device malfunction [device malfunction] inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now/cannot run around and cannot walk/couldn't move/couldn't get around the edge of the bed [unable to walk] right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen [swelling of r knee] screaming" with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth [knee pain] ([condition aggravated]) drag my foot when i walked with a walker [foot discomfort] could not put weight on leg [weight bearing difficulty] unable to bend the right knee/couldn't put weight on it [joint range of motion decreased] nauseated [nauseated] tired [tiredness] unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out [joint stiffness] "cannot sleep because (she) feels like a zombie [feeling abnormal] c-reactive protien elevated [c-reactive protein increased] white blood cell count elevated [white blood cell count decreased] discomfort [discomfort] did not get releif with the injection [device ineffective].Case narrative: this case is related to case id: (b)(4).(same patient) this case is cross reference with case id: (b)(4).(cluster: patient husband).This spontaneous legal case from united states was received on 23-jan-2018 from patient's husband.This case concerns a 61 years old female patient who initiated treatment with synvisc one and after a few hours had inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now/couldn't move/couldn't get around the edge of the bed, unable to bend the right knee/couldn't put weight on it, on the same day had to drag my foot when i walked with a walker,was screaming" with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth, had right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen, was unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out also, device malfunction was identified for the reported lot number, white blood cell count elevated (after unknown latency), c-reactive protein elevated (after unknown latency), "cannot sleep because (she) feels like a zombie (after unknown latency), nauseated (after unknown latency) and tired (after unknown latency) and needed to use a wheelchair (after unknown latency), discomfort (after unknown latency).Concomittant medication included ibuprofen (ibuprofen), montelukast sodium (singulair), pravastatin sodium, levothyroxine sodium (synthroid), ranitidine hydrochloride (zantac), budesonide, formoterol fumarate (symbicort) and zolpidem tartrate (ambien) and concurrent conditions were reported.The patient's medical history was significant for fluid in both ears (1 month ago) for which the patient was prescribed treatment with prednisone.The patient denied any prosthetic device or any allergy to proteins, feathers, or egg products, denied history of diabetes.The patient had past treatment with synvisc-one (injections and a couple of years prior to that she's had the synvisc 3 series injections from a different hcp; injections in the past were great and she told everyone with knee pain to get them, and now was afraid to get a synvisc-one injection again and is worried about the long term adverse effects).Her past medical history included gerd, asthma, thyroid disease, lung disease, gallbladder/cholecystectomy and cesarean section and augmentin allergy.On (b)(6) 2017 , patient received treatment with intra articular synvisc one injection at a dose of 10 ml (frequency: not provided) for osteoarthritis and torn meniscus (batch/ lot number: 7rsl021 and expiry date: unknown).It was reported that the patient had been avoiding surgery.On the same day, after a few hours, patient was screaming with pain, inability to walk, unable to straighten out her right leg, right knee had swelling the size of a baseball, unable to bend the right knee.During the first week first week she used ice, elevation, slept in a low bed, and used a walker to go to the bathroom.Patient's hcp prescribed 600-800 motrin, elevation, ice, and she was wearing a molded knee brace.Patient reported that no circumference measurements had been taken of the right knee, she was unable to bare weight or walk after this injection, and had pain level of 10 after this injection, denied fever, had blood work but was not sure for what, turned wrong this weekend and hurt her knee, had not recovered from this injection.It was reported that, patient had seen her orthopedist for follow-up assessment.She found out that she received the affected synvisc-one recall lot number product.Her follow-up bloodwork indicated that her white blood cell count and c-reactive protein (both on unknown dates, after unknown latencies) were both elevated (no laboratory values were reported).Intraarticular fluid from the affected right knee was aspirated by the orthopedist and laboratory results were "negative for any bacterial growth".On (b)(6) 2018,patient presented to healthcare facilty and it was observed that by her she did not get any relief.On (b)(6) 2018, she also received a cortisone injection which "worked a little" and later she underwent the b loodwork.She had an appointment scheduled for the second week of (b)(6) 2018.However, she would be calling the orthopedist to determine if the orthopedist would like to see her earlier.It was reported that, in the past, patient received immediate relief with synvisc-one injection(s).However, she had a much different experience after receiving the recalled synvisc-one lot number product.As mentioned in the initial ae report, she initially experienced discomfort after that injection (unknown date, after unknown latency).But by that evening, she was "screaming in pain".And "now her right knee would not straighten out".On an unknown date, after unknown latency, patient has felt nauseated and she "cannot babysit grandchildren as she cannot run around, cannot walk good because she feels tired (an unknown date, after unknown latency) and she needed to use a wheelchair".Moreover, as treatment, her orthopedist has recommended that she wear "one of two braces on (her) knee which had created problems with clothing".She does not want to gain weight (from lack of mobility).The patient was instructed to place ice on the knee.So she placed ice and also applied a cream arnica montana/boswellia serrata/eucalyptus/ilex/menthol/peppermint oil (cryoderm) to the knee, both of which have worked (even though the cream was not recommended by the orthopedist for such use).On an unknown date, after unknown latency, patient cannot sleep because she feels like a zombie.Action taken: unknown.Corrective treatment: molded knee brace, wheel chair for inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now, couldn't move/couldn't get around the edge of the bed; ice for u unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out; ice, elevation, ibuprofen (motrin) cortisone injection for right knee arthritis ; ice, elevation, ibuprofen (motrin), arnica montana/boswellia serrata/eucalyptus/ilex/menthol/peppermint oil (cryoderm) and cortisone injection for screaming" with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth; ice and arnica montana/boswellia serrata/eucalyptus/ilex/menthol/peppermint oil (cryoderm) for unable to bend the right knee/couldn't put weight on it; not reported for "cannot sleep because (she) feels like a zombie, nauseated, discomfort, needed to use a wheelchair and tired, white blood cell count elevated, c-reactive protein elevated.Outcome: unknown for discomfort, tired, nauseated, "cannot sleep because (she) feels like a zombie, white blood cell count elevated, c-reactive protein elevated; not recovered for rest all events.Seriousness criteria: disability for device malfunction and inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now; required intervention for white blood cell count elevated and c-reactive protein elevated.A global pharmaceutical technical complaint 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.Additional information was received on 06-feb-2018.The gptc number was added.Text was amended accordingly.Additional information was received on 28-feb-2018 from patient.Related case id added.Additional events of tired, white blood cell count elevated, c-reactive protein elevated, "cannot sleep because (she) feels like a zombie, nauseated and discomfort were added with details.Event unable to bend the right knee/couldn't put weight on it corrective treatment updated.Event verbatim updated from: unable to straighten out her right leg/can't straighten it/couldn't straighten my leg to unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out.Clinical course updated.Text amended accordingly.Additional information was received on 07-feb-2019 from the lawyer.Case was upgraded to legal case.Medical history of gerd, asthma, thyroid disease, lung disease, gallbladder/cholecystectomy and cesarean section and augmentin allergy were added.Concomitant medications of ibuprofen, singulair, pravastatin sodium, synthroid, zantac, symbicort and ambien were added.Event of did not got relief was added.Verbatim for inability to walk/unable to walk after this injection was updated to inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now/cannot run around and cannot walk/couldn't move/couldn't get around the edge of the bed.Date of previous synvisc one was added.Clinical course updated.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction], possible methylobacterium thiocynatum infection/ possible infection in knee [joint infection] ([methylobacterium infection]), inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now/cannot run around and cannot walk/couldn't move/couldn't get around the edge of the bed/can barely walk [unable to walk], right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen [swelling of r knee], screaming with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth/pain was sharp, throbbing, burning and aching [aching (r) knee] ([injection site burning], [throbbing pain], [condition aggravated]), drag my foot when i walked with a walker [foot discomfort] , could not put weight on leg [weight bearing difficulty] , unable to bend the right knee/couldn't put weight on it [joint range of motion decreased], cannot sleep because (she) feels like a zombie [feeling abnormal], c-reactive protien elevated [c-reactive protein increased], white blood cell count elevated [white blood cell count decreased] , discomfort [discomfort], nauseated [nauseated], tired [tiredness], did not get relief with the injection [device ineffective], unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out [joint stiffness].Case narrative: this case is cross referenced with case (b)(4) (cluster: patient husband) and (b)(4) (same patient).Initial information received on 23-jan-2018 from united states regarding an unsolicited valid legal serious malfunction case received from a lawyer.This case concerns a 61 years old female patient (height 152.4 cm and weight 73.4kgs) who initiated treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and after a few hours had inability to inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now/cannot run around and cannot walk/couldn't move/couldn't get around the edge of the bed/can barely walk, unable to bend the right knee/couldn't put weight on it, on the same day had to drag my foot when i walked with a walker, screaming with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth/pain was sharp, throbbing, burning and aching, had right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen, was unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out, white blood cell count elevated (after unknown latency), c-reactive protein elevated (after unknown latency), "cannot sleep because (she) feels like a zombie (after unknown latency), nauseated (after unknown latency) and tired (after unknown latency), discomfort (after unknown latency), possible methylobacterium thiocynatum infection/ possible infection in knee (latency: 2 months 23 days).Additionally, device malfunction was identified for the reported lot number.The patient's medical history was significant for fluid in both ears (1 month ago) for which the patient was prescribed treatment with prednisone, gerd, arthritis, asthma, thyroid disease, mole removal-benign, biopsy-skin, gallbladder/cholecystectomy and cesarean section.Concurrent condition included allergy to augmentin (severe).The patient denied any prosthetic device or any allergy to proteins, feathers, or egg products, denied history of diabetes.The patient was an ex-smoker.She does not drink alcoholic beverages.Family history included lung disease (father) concomitant medication included ibuprofen (ibuprofen), montelukast sodium (singulair), pravastatin sodium, levothyroxine sodium (synthroid), ranitidine hydrochloride (zantac), budesonide, formoterol fumarate (symbicort) and zolpidem tartrate (ambien).Patient had got very good relief with hyaluronic acid injections in the past.On (b)(6) 2017, patient received treatment with intra articular injection of hylan g-f 20, sodium hyaluronate at a dose of 6 ml, once for osteoarthritis and torn meniscus (batch/ lot number: 7rsl021 and expiry date: unknown) into right knee under sterile conditions.At the time of her visit, patient described her pain as sharp, aching, on and off in character and related to activity and rated it 8 on scale of 10, and at its worst it, she rated it 10.It was reported that the patient had been avoiding surgery.On the same day, after a few hours, patient was screaming with pain, inability to walk, unable to straighten out her right leg, right knee had swelling the size of a baseball, unable to bend the right knee.On (b)(6) 2017, patient reported for follow up of her knee pain and complained of being in a lot of pain, could barely walk and knee was swollen.She was instructed to use ice and use ibuprofen.During the first week first week she used ice, elevation, slept in a low bed, and used a walker to go to the bathroom.Patient's hcp prescribed 600-800 motrin, elevation, ice, and she was wearing a molded knee brace.Patient reported that no circumference measurements had been taken of the right knee, she was unable to bare weight or walk after this injection, and had pain level of 10 after this injection, denied fever, had blood work but was not sure for what, turned wrong this weekend and hurt her knee, had not recovered from this injection.It was reported that, patient had seen her orthopedist for follow-up assessment.She found out that she received the affected synvisc-one recall lot number product.Her follow-up bloodwork indicated that her white blood cell count and c-reactive protein (both on unknown dates, after unknown latencies) were both elevated (no laboratory values were reported).Intraarticular fluid from the affected right knee was aspirated by the orthopedist and laboratory results were "negative for any bacterial growth".On (b)(6) 2018, patient presented to healthcare facility and it was observed that by her she did not get any relief with the injection.She reported her knee was worse and swollen.She rated her pain 8 on a scale of 10 and described it as sharp, throbbing, stabbing and aching.The pain at its worst is a 10 out of 10.The timing of the pain is intermittent, occurring at rest, awakening patient from sleep, related to activity.The same day, patient received steroid and analgesic medication for her right knee pain.An injection was performed into right knee under sterile conditions using 2cc of bethamethasone, 2cc of 1% lidocaine and 2cc of 0.25% marcaine.The patient was informed about the numbing agent and was told it would last 2-3 hours, but the cortisone may not begin to work for 3-4 days.Prior to injecting, 1-2 cc of normal appearing clear yellow fluid was aspirated from right knee and sent for culture.The reports of her knee fluid culture were suggestive of a possible methylobacterium thiocynatum infection (latency: 2 months 23 days).This event was assessed as serious due to seriousness criterion of medically significant.The patient had received the injection from the recall lot and was concerned about possible infection.The patient described her pain as sharp, aching, on and off in character and related to activity and rated it 8 on scale of 10, and at its worst it, she rated it 10.On 31-jan-2018, patients lab culture reports revealed possible infection in knee.On (b)(6) 2018, she also received a cortisone injection which "worked a little" and later she underwent the bloodwork.She had an appointment scheduled for the second week of (b)(6) 2018.However, she would be calling the orthopedist to determine if the orthopedist would like to see her earlier.It was reported that, in the past, patient received immediate relief with synvisc-one injection(s).However, she had a much different experience after receiving the recalled synvisc-one lot number product.As mentioned in the initial ae report, she initially experienced discomfort after that injection (unknown date, after unknown latency).But by that evening, she was "screaming in pain".And "now her right knee would not straighten out".On (b)(6) 2018, patient reported again for follow up of his right knee pain.She reported that she feels worse that the last visit and rated her pain 8 on a scale of 10.The pain was sharp, throbbing, burning and aching.She described the pain as constant.Further, the patient was using an unloader brace.She reported that the steroid injection provided her relief for 2-2.5 months and thought wanted to repeat it.She was administered a steroid and analgesic medicine.An injection was performed into right knee under sterile conditions using 2cc of bethamethasone, 2cc of 1% lidocaine and 2cc of 0.25% marcaine.On (b)(6) 2018, patient reported for follow up of her right knee pain.She rated her pain 7 out of 10 and at its worst it was at 9.She added that the pain was constant and related to activity.The cortisone injection provided her relief for about two months, after which her pain started coming back, so she was interested in receiving another injection.Reportedly synvisc one was from a contaminated lot and she had a reaction to it so she was apprehensive.The possibility of going back to another type of hyaluronic acid was discussed or about receiving the three series injection, with the patient.She received another cortisone injection in her knee under sterile conditions.An injection was performed into right knee under sterile conditions using 2cc of bethamethasone, 2cc of 1% lidocaine and 2cc of 0.25% marcaine.The patient was informed about the numbing agent and was told it would last 2-3 hours, but the cortisone may not begin to work for 3-4 days.On (b)(6) 2018, patient called stating she was still in pain and her right knee pain radiating up and down.The doctor reported that it was too soon for her to received another cortisone injection and asked if she would be willing to receive another hyaluronic injection.On (b)(6) 2018, patient reported for follow up of her right knee pain.She had received a cortisone injection, 10 weeks ago and reported that it helped reduce her pain for about 1.5 months.The patient rated it at 9 on a scale of 10.The pain at its worst was rated 10.She described it as sharp, stabbing, burning, aching and constant in nature.The same day, she received an intraarticular injection of viscosupplement medication in her right knee.The patient was counselled regarded her various options for treatment and the ultimate need for undergoing knee replacement.She finally decided to try a single injection of gel1.The patient tolerated the procedure well and aspiration was done prior to injecting the gel1, in her right knee under sterile conditions.On an unknown date, after unknown latency, patient has felt nauseated and she "cannot babysit grandchildren as she cannot run around, cannot walk good because she feels tired (an unknown date, after unknown latency) and she needed to use a wheelchair".Moreover, as treatment, her orthopedist has recommended that she wear "one of two braces on (her) knee which had created problems with clothing".She does not want to gain weight (from lack of mobility).The patient was instructed to place ice on the knee.So she placed ice and also applied a cream arnica montana/boswellia serrata/eucalyptus/ilex/menthol/peppermint oil (cryoderm) to the knee, both of which have worked (even though the cream was not recommended by the orthopedist for such use).On an unknown date, after unknown latency, patient cannot sleep because she feels like a zombie.Action taken: not applicable.Corrective treatment: molded knee brace, wheel chair for inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now/cannot run around and cannot walk/couldn't move/couldn't get around the edge of the bed/can barely walk; ice for u unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out; ice, elevation, ibuprofen (motrin) cortisone injection for right knee arthritis ; ice, elevation, ibuprofen (motrin), arnica montana/boswellia serrata/eucalyptus/ilex/menthol/peppermint oil (cryoderm) and cortisone injection for screaming" with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth; ice and arnica montana/boswellia serrata/eucalyptus/ilex/menthol/peppermint oil (cryoderm) for unable to bend the right knee/couldn't put weight on it; not reported for "cannot sleep because (she) feels like a zombie, nauseated, discomfort, and tired, white blood cell count elevated, c-reactive protein elevated outcome: unknown for possible methylobacterium thiocynatum infection/ possible infection in knee, discomfort, tired, nauseated, "cannot sleep because (she) feels like a zombie, white blood cell count elevated, c-reactive protein elevated; not recovered for rest all events seriousness criteria: disability for device malfunction and inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now/cannot run around and cannot walk/couldn't move/couldn't get around the edge of the bed/can barely walk; required intervention for white blood cell count elevated and c-reactive protein elevated; medically significant for possible methylobacterium thiocynatum infection/ possible infection in knee.A global pharmaceutical technical complaint 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.Additional information was received on 06-feb-2018.The gptc number was added.Text was amended accordingly.Additional information was received on 28-feb-2018 from patient.Related case id added.Additional events of tired, white blood cell count elevated, c-reactive protein elevated, "cannot sleep because (she) feels like a zombie, nauseated and discomfort were added with details.Event unable to bend the right knee/couldn't put weight on it corrective treatment updated.Event verbatim updated from: unable to straighten out her right leg/can't straighten it/couldn't straighten my leg to unable to straighten out her right leg/can't straighten it/couldn't straighten my leg/now her right knee will not straighten out.Clinical course updated.Text amended accordingly.Additional information was received on 07-feb-2019 from the lawyer.Case was upgraded to legal case.Medical history of gerd, asthma, thyroid disease, lung disease, gallbladder/cholecystectomy and cesarean section and augmentin allergy were added.Concomitant medications of ibuprofen, singulair, pravastatin sodium, synthroid, zantac, symbicort and ambien were added.Event of did not got relief was added.Verbatim for inability to walk/unable to walk after this injection was updated to inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now/cannot run around and cannot walk/couldn't move/couldn't get around the edge of the bed.Date of previous synvisc one was added.Clinical course updated.Text amended accordingly.Additional information received on 01-jul-2019 from lawyer.Patients weight and height added.Suspect product dose and frequency updated.Medical history of mole removal-benign, biopsy-skin, arthritis added.Event of possible methylobacterium thiocynatum infection/ possible infection in knee.Verbatim updated from screaming with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth to screaming with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth/pain was sharp, throbbing, burning and aching.Events of sharp, throbbing, burning and aching and burning added as symptoms of screaming with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth/pain was sharp, throbbing, burning and aching.Clinical course updated.Text amended accordingly.
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