| Lot Number 7RSL021 |
| Device Problem
Microbial Contamination of Device (2303)
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| Patient Problems
Arthritis (1723); Loss of Range of Motion (2032); Myalgia (2238); No Code Available (3191)
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| Event Date 11/01/2017 |
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Event Type
Injury
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Event Description
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Device malfunction [device malfunction], could not get up/could no longer move/could not get on/off toilet [mobility decreased], pain in his foot [foot pain], can only walk without it for about 10 to 15 minutes/difficulty moving/walking with an obvious limp [difficulty in walking], lots of limited motion/range of motion is limited with crepitus [joint range of motion decreased], antalgic gait [antalgic gait], crepitus [joint crepitation], mild degree of atrophy of the muscles surrounding the knee [muscle atrophy], unable to drive [impaired driving ability], feeling sleepy [sleepy], pain involving left shoulder [shoulder pain], rotator cuff tear in his left shoulder [rotator cuff tear], global weakness [weakness], still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness [knee pain], there is an effusion [knee effusion].Case narrative: upon internal review on 11-jan-2019, the case was upgraded to serious from non-serious (seriousness criteria of device malfunction as medically significant added).Based on additional information received on 10-may-2018, this case became medically confirmed.This spontaneous legal case from united states was received on (b)(6) 2017 from the patient.This case concerns a patient (b)(6) year old male who initiated treatment with synvisc one and after an unknown latency could not get up/could no longer move/could not get on/off toilet, had pain in his foot, can only walk without it for about 10 to 15 minutes, still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness, lots of limited motion/range of motion was limited with crepitus, antalgic gait, crepitus, mild degree of atrophy of the muscles surrounding the knee, unable to drive, there was an effusion, feeling sleepy, rotator cuff tear in his left shoulder, global weakness.Additionally, event of device malfunction was also there as recall lot was identified.The patient had penicillin allergy and was a non-smoker.The patient had history of hemorrhoids, inguinal hernia and kidney disease.The patient's mother had history of diabetes mellitus, malignant neoplasm and heart trouble.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, at 13:30, patient received treatment with intra articular synvisc one injection once at a dose of 6 ml for knee pain (batch/lot number: 7rsl021; expiration date: may-2020) for knee pain, joint pain, osteoarthritis and inflammation to bilateral knees and tolerated them very well.He would follow up as needed.At 14:02, patient's blood pressure was 147/52mmhg and heart rate was 100 beats/min.On an unknown date in (b)(6) 2017, after an unknown latency started experiencing excruciating pain at pain level 9 after 7 pm post injection.He laid down and could not get up; he used a cane and about half way, he could no longer move.Patient had to get a neighbor to help him get up, could not get on/off toilet.He called hcp to see if he needed to go to the emergency department.Patient used pain pills tramadol, tylenol, ice and rest.The pain started to relieve the day after injection but it never ever stopped hurting.He stated that if he was walking, he would stop and have pain in his foot.Patient denied doing any exercise.Denied knee swelling.He did not use a cane before injection but was using one now.Patient reported that he can only walk without it for about 10 to 15 minutes.Patient mentioned that the right knee was more painful than the left.On unknown dates, after unknown latencies, the patient experienced lots of limited motion/range of motion was limited with crepitus, antalgic gait, crepitus, mild degree of atrophy of the muscles surrounding the knee, unable to drive, there was an effusion, feeling sleepy, rotator cuff tear in his left shoulder, global weakness.On (b)(6) 2017, the patient called with complaints of severe pain, soreness and limited motion.The patient states his symptoms have improved since last night but is still painful.I lvm and have instructed the patient to take ibuprofen, ice and tramadol.On (b)(6) 2017, the called spoke on the phone and told that his symptoms were somewhat better but was still very painful.He was experiencing symptoms of joint pain, trouble moving the joint, feeling sleepy as well as shoulder pain and aches.He states these symptoms developed after the injections.He states that the right knee was the worse.The patient also states he was unable to drive barely 6 miles away from his home due to the pain and difficulty moving.He was aware of this recall.He has been informed to come into the office as soon as possible.The patient stated it was very difficult for him to drive so he may not be able to come in.However, he did want to make the appointment.On unknown dates, after unknown latencies, patient was walking with an obvious limp and antalgic gait.Patient utilized an assist device.The patient showed varus alignment.The patient was tender to palpation primarily along the medial joint line.There was an effusion.There was no erythema or warmth.Range of motion was limited and associated with crepitus.There was mild degree of atrophy of the muscles surrounding the knee.With valgus stress testing there was mild gapping medially consistent with loss of the medial joint space.Motor strength was 5 over 5 in all groups tested but was slightly inhibited by discomfort.Sensory examination was within normal limits.The patient was experiencing adverse event related to recall the synvisc knee injections.Interestingly the patient had no local reaction.By his history there was no swelling or erythema.However, the patient had described global weakness and pain involving both knees and left shoulder.On physical findings on (b)(6) 2018 outside of what was known about his badly arthritic knees the patient does appear to have a rotator cuff tear in his left shoulder.The patient was counseled that he could not see how this would in any way be related to his lubricant injection.Nonetheless, he was provided with a contact for specialist in that area.With regard to his knees the patient was a candidate for knee replacement surgery.Corrective treatment: cane for could not get up/could no longer move/could not get on/off toilet and can only walk without it for about 10 to 15 minutes; tramadol, tylenol, ice and rest for pain in his foot and still having pain/excruciating pain at pain level 9/never ever stopped hurting/right knee was more painful than the left; assistance device for antalgic gait; not reported for rest of the events.Outcome: recovering for lots of limited motion/range of motion is limited with crepitus, still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness; unknown for rest all events.A pharmaceutical technical complaint was initiated with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant for device malfunction.Additional information was received on 04-feb-2018.Ptc (pharmaceutical technical complaint) results were added.Text was amended accordingly.Additional information was received on 10-may-2018 from the medical doctor.Additional events of device malfunction, lots of limited motion/range of motion was limited with crepitus, antalgic gait, crepitus, mild degree of atrophy of the muscles surrounding the knee, unable to drive, there was an effusion, feeling sleepy, rotator cuff tear in his left shoulder, global weakness were added.Symptoms added for arthritis bacterial arthritis infective/ synovial fluid left knee/ low-grade septic arthritis.Event term of still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness was updated.Medical history and concurrent conditions were added.Suspect product batch number, expiration date and indications were added.Clinical course was updated and text was amended accordingly.Additional information was received on 08-jan-2019 from lawyer.Upon internal review on 11-jan-2019, the case was upgraded to serious from non-serious (seriousness criteria of device malfunction as medically significant added).Classification added.
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Event Description
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Device malfunction [device malfunction] can only walk without it for about 10 to 15 minutes/difficulty moving/walking with an abvious limp/antalgic gait/limp [difficulty in walking] could not get up/could no longer move/could not get on/off toilet [mobility decreased] pain in his foot [foot pain] lots of limited motion/range of motion is limited with crepitus [joint range of motion decreased] crepitus [joint crepitation] mild degree of atrophy of the muscles surrounding the knee [muscle atrophy] uanble to drive [impaired driving ability] feeling sleepy [sleepy] pain involving left shoulder [shoulder pain] rotator cuff tear in his left shoulder [rotator cuff tear] global weakness [weakness generalised] still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness [knee pain] there is an effusion [knee effusion] case narrative: upon internal review on 11-jan-2019, the case was upgraded to serious from non-serious (seriousness criteria of device malfunction as medically significant added).Based on additional information received on 10-may-2018, this case became medically confirmed.This case is cross referenced with case (b)(4).This spontaneous non-serious valid legal case from united states was received on 21-dec-2017 from the patient.This case concerns a patient 74 year old male who initiated treatment with hylan g-f 20, sodium hyaluronate (synvisc-one) and after an unknown latency could not get up/could no longer move/could not get on/off toilet, had pain in his foot, can only walk without it for about 10 to 15 minutes/difficulty moving/walking with an obvious limp/antalgic gait/limp, still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness, lots of limited motion/range of motion was limited with crepitus, crepitus, mild degree of atrophy of the muscles surrounding the knee, unable to drive, there was an effusion, feeling sleepy, rotator cuff tear in his left shoulder, global weakness.Additionally, event of device malfunction was also there as recall lot was identified.The patient had history of hemorrhoids, inguinal hernia and kidney disease.The patient's mother had history of diabetes mellitus, malignant neoplasm, heart trouble, pain, infection of prostate tubes, contact dermatitis rash, bilateral osteoarthritis, knee pain, mucus coming out, bad cough, joint aches, pain in both shoulders and pain in legs.Concurrent condition of penicillin allergy.The patient was a non-smoker.No previous medications were reported.Concomitant medication included tramadol hcl.On 15-nov-2017, at 13:30, patient received treatment with intra articular hylan g-f 20, sodium hyaluronate injection once at a dose of 6 ml for knee pain (batch/lot number: 7rsl021; expiration date: may-2020) for knee pain, joint pain, osteoarthritis and inflammation to bilateral knees and tolerated them very well.An alcohol was used to prep the area and ethyl chloride spray was used as a topical anesthetic.The site was injected with 6 ml of hylan g-f 20, sodium hyaluronate.A bandaid was applied and the patient tolerated the procedure well.Patient was instructed to avoid strenuous activity for 3 days.He would follow up as needed.At 14:02, patient's blood pressure was 147/52mmhg and heart rate was 100 beats/min.On an unknown date in nov-2017, after an unknown latency started experiencing excruciating pain at pain level 9 after 7 pm post injection.He laid down and could not get up; he used a cane and about half way, he could no longer move.Patient had to get a neighbor to help him get up, could not get on/off toilet.He called hcp to see if he needed to go to the emergency department.Patient used pain pills tramadol, tylenol, ice and rest.The pain started to relieve the day after injection but it never ever stopped hurting.He stated that if he was walking, he would stop and have pain in his foot.Patient denied doing any exercise.Denied knee swelling.He did not use a cane before injection but was using one now.Patient reported that he can only walk without it for about 10 to 15 minutes.Patient mentioned that the right knee was more painful than the left.On unknown dates, after unknown latencies after the injection, the patient experienced lots of limited motion/range of motion was limited with crepitus, antalgic gait, crepitus, unable to drive, there was an effusion, feeling sleepy, rotator cuff tear in his left shoulder, global weakness.On 17-nov-2017, the patient called with complaints of severe pain, soreness and limited motion.The patient states his symptoms have improved since last night but is still painful.I lvm and have instructed the patient to take ibuprofen, ice and tramadol.On 15-dec-2017, patient stated that he was slowly improving and was now able to walk with a cane.However, he has had pain, weakness and pain when getting up from sitting position.On 21-dec-2017, the called spoke on the phone and told that his symptoms were somewhat better but was still very painful.He was experiencing symptoms of joint pain, trouble moving the joint, feeling sleepy as well as shoulder pain and aches.He states these symptoms developed after the injections.He states that the right knee was the worse.The patient also states he was unable to drive barely 6 miles away from his home due to the pain and difficulty moving.He was aware of this recall.He has been informed to come into the office as soon as possible.The patient stated it was very difficult for him to drive so he may not be able to come in.However, he did want to make the appointment.On 27-dec-2017, patient was still having the symptoms.On 03-jan-2018, patient reported to the clinic for follow up of his bilateral knee osteoarthritis.Since the injections, patient has had difficulty moving, lots of limited motion, felling sleepy and also, states that the knees are very painful and he ambulated with a cane.Upon physical examination, it was noted that the patient was walking with a limp, had an antalgic gait and used an assistive device.The patient shows varus alignment an was tender to palpation primarily along the mecnal joint tine.An effusion was noticed without erythema or warmth, range of motion was limited and was associated with crepitus.Further, a mild degree of atrophy of the muscles surrounding the knee (latency: 1 month 19 days) was also observed.With valgus stress testing there is mild gapping medially consistent with loss of the medial joint space.Motor strength is 5 over 5 in all groups tested but is slightly inhibited by discomfort.It was reported that the patient was experiencing adverse event related to recall the synvisc knee injections.Interestingly the patient had no local reaction.By his history there was no swelling or erythema.However, the patient had described global weakness and pain involving both knees and left shoulder.On physical findings on 03-jan-2018 outside of what was known about his badly arthritic knees the patient does appear to have a rotator cuff tear in his left shoulder.The patient was counseled that he could not see how this would in any way be related to his lubricant injection.Nonetheless, he was provided with a contact for specialist in that area.With regard to his knees the patient was a candidate for knee replacement surgery.Corrective treatment: cane for could not get up/could no longer move/could not get on/off toilet, cane and assistance device for can only walk without it for about 10 to 15 minutes/difficulty moving/walking with an abvious limp/antalgic gait/limp; tramadol, tylenol, ice and rest for pain in his foot and still having pain/excruciating pain at pain level 9/never ever stopped hurting/right knee was more painful than the left; not reported for rest of the events outcome: recovering for lots of limited motion/range of motion is limited with crepitus, still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness, can only walk without it for about 10 to 15 minutes/difficulty moving/walking with an obvious limp/antalgic gait/limp; unknown for rest all events a pharmaceutical technical complaint was initiated with global ptc number: 51547 an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant for device malfunction and disability for can only walk without it for about 10 to 15 minutes/difficulty moving/walking with an obvious limp/antalgic gait/limp additional information was received on 04-feb-2018.Ptc (pharmaceutical technical complaint) results were added.Text was amended accordingly.Additional information was received on 10-may-2018 from the medical doctor.Additional events of device malfunction, lots of limited motion/range of motion was limited with crepitus, antalgic gait, crepitus, mild degree of atrophy of the muscles surrounding the knee, unable to drive, there was an effusion, feeling sleepy, rotator cuff tear in his left shoulder, global weakness were added.Symptoms added for arthritis bacterial arthritis infective/ synovial fluid left knee/ low-grade septic arthritis.Event term of still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness was updated.Medical history and concurrent conditions were added.Suspect product batch number, expiration date and indications were added.Clinical course was updated and text was amended accordingly.Additional information was received on 08-jan-2019 from lawyer.Upon internal review on 11-jan-2019, the case was upgraded to serious from non-serious (seriousness criteria of device malfunction as medically significant added).Classification added.Additional information received on 15-mar-2019 from lawyer.Medical history of pain, infection of prostate tubes, contact dermatitis rash, bilateral osteoarthritis, knee pain, mucus coming out, bad cough, joint aches, pain in both shoulders and pain in legs.Clinical course updated.Text amended accordingly.Additional information received on 05-apr-2019 from lawyer.Medical history of penicillin allergy added.Concomitant medication of tramadol hcl added.Verbatim updated to can only walk without it for about 10 to 15 minutes/difficulty moving/walking with an obvious limp/antalgic gait/limp (events merged).Clinical course updated.Text amended accordingly.
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Event Description
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Device malfunction [device malfunction] can only walk without it for about 10 to 15 minutes/difficulty moving/walking with an abvious limp [difficulty in walking] could not get up/could no longer move/could not get on/off toilet [mobility decreased] pain in his foot [foot pain] lots of limited motion/range of motion is limited with crepitus [joint range of motion decreased] antalgic gait [antalgic gait] crepitus [joint crepitation] mild degree of atrophy of the muscles surrounding the knee [muscle atrophy] uanble to drive [impaired driving ability] feeling sleepy [sleepy] pain involving left shoulder [shoulder pain] rotator cuff tear in his left shoulder [rotator cuff tear] global weakness [weakness] still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness [knee pain] there is an effusion [knee effusion] case narrative: upon internal review on 11-jan-2019, the case was upgraded to serious from non-serious (seriousness criteria of device malfunction as medically significant added).Based on additional information received on 10-may-2018, this case became medically confirmed.This spontaneous legal case from united states was received on (b)(6) 2017 from the patient.This case concerns a patient 74 year old male who initiated treatment with synvisc one and after an unknown latency could not get up/could no longer move/could not get on/off toilet, had pain in his foot, can only walk without it for about 10 to 15 minutes, still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness, lots of limited motion/range of motion was limited with crepitus, antalgic gait, crepitus, mild degree of atrophy of the muscles surrounding the knee, unable to drive, there was an effusion, feeling sleepy, rotator cuff tear in his left shoulder, global weakness.Additionally, event of device malfunction was also there as recall lot was identified.The patient had penicillin allergy and was a non-smoker.The patient had history of hemorrhoids, inguinal hernia and kidney disease.The patient's mother had history of diabetes mellitus, malignant neoplasm, heart trouble, pain, infection of prostate tubes, contact dermatitis rash, bilateral osteoarthritis, knee pain, mucus coming out, bad cough, joint aches, pain in both shoulders and pain in legs.No previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, at 13:30, patient received treatment with intra articular synvisc one injection once at a dose of 6 ml for knee pain (batch/lot number: 7rsl021; expiration date: may-2020) for knee pain, joint pain, osteoarthritis and inflammation to bilateral knees and tolerated them very well.He would follow up as needed.At 14:02, patient's blood pressure was 147/52mmhg and heart rate was 100 beats/min.On an unknown date in non-2017, after an unknown latency started experiencing excruciating pain at pain level 9 after 7 pm post injection.He laid down and could not get up; he used a cane and about half way, he could no longer move.Patient had to get a neighbor to help him get up, could not get on/off toilet.He called hcp to see if he needed to go to the emergency department.Patient used pain pills tramadol, tylenol, ice and rest.The pain started to relieve the day after injection but it never ever stopped hurting.He stated that if he was walking, he would stop and have pain in his foot.Patient denied doing any exercise.Denied knee swelling.He did not use a cane before injection but was using one now.Patient reported that he can only walk without it for about 10 to 15 minutes.Patient mentioned that the right knee was more painful than the left.On unknown dates, after unknown latencies, the patient experienced lots of limited motion/range of motion was limited with crepitus, antalgic gait, crepitus, mild degree of atrophy of the muscles surrounding the knee, unable to drive, there was an effusion, feeling sleepy, rotator cuff tear in his left shoulder, global weakness.On (b)(6) 2017, the patient called with complaints of severe pain, soreness and limited motion.The patient states his symptoms have improved since last night but is still painful.I lvm and have instructed the patient to take ibuprofen, ice and tramadol.On (b)(6) 2017, the called spoke on the phone and told that his symptoms were somewhat better but was still very painful.He was experiencing symptoms of joint pain, trouble moving the joint, feeling sleepy as well as shoulder pain and aches.He states these symptoms developed after the injections.He states that the right knee was the worse.The patient also states he was unable to drive barely 6 miles away from his home due to the pain and difficulty moving.He was aware of this recall.He has been informed to come into the office as soon as possible.The patient stated it was very difficult for him to drive so he may not be able to come in.However, he did want to make the appointment.On unknown dates, after unknown latencies, patient was walking with an obvious limp and antalgic gait.Patient utilized an assist device.The patient showed varus alignment.The patient was tender to palpation primarily along the medial joint line.There was an effusion.There was no erythema or warmth.Range of motion was limited and associated with crepitus.There was mild degree of atrophy of the muscles surrounding the knee.With valgus stress testing there was mild gapping medially consistent with loss of the medial joint space.Motor strength was 5 over 5 in all groups tested but was slightly inhibited by discomfort.Sensory examination was within normal limits.The patient was experiencing adverse event related to recall the synvisc knee injections.Interestingly the patient had no local reaction.By his history there was no swelling or erythema.However, the patient had described global weakness and pain involving both knees and left shoulder.On physical findings on (b)(6) 2018 outside of what was known about his badly arthritic knees the patient does appear to have a rotator cuff tear in his left shoulder.The patient was counseled that he could not see how this would in any way be related to his lubricant injection.Nonetheless, he was provided with a contact for specialist in that area.With regard to his knees the patient was a candidate for knee replacement surgery.Corrective treatment: cane for could not get up/could no longer move/could not get on/off toilet and can only walk without it for about 10 to 15 minutes; tramadol, tylenol, ice and rest for pain in his foot and still having pain/excruciating pain at pain level 9/never ever stopped hurting/right knee was more painful than the left; assistance device for antalgic gait; not reported for rest of the events outcome: recovering for lots of limited motion/range of motion is limited with crepitus, still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness; unknown for rest all events.A pharmaceutical technical complaint was initiated with global ptc number:(b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant for device malfunction and disability for can only walk without it for about 10 to 15 minutes/difficulty moving/walking with an abvious limp additional information was received on 04-feb-2018.Ptc (pharmaceutical technical complaint) results were added.Text was amended accordingly.Additional information was received on 10-may-2018 from the medical doctor.Additional events of device malfunction, lots of limited motion/range of motion was limited with crepitus, antalgic gait, crepitus, mild degree of atrophy of the muscles surrounding the knee, unable to drive, there was an effusion, feeling sleepy, rotator cuff tear in his left shoulder, global weakness were added.Symptoms added for arthritis bacterial arthritis infective/ synovial fluid left knee/ low-grade septic arthritis.Event term of still having pain/excruciating pain at pain level "9"/never ever stopped hurting/right knee was more painful than the left/pain involving both knees/knees are very painful/severe pain, soreness was updated.Medical history and concurrent conditions were added.Suspect product batch number, expiration date and indications were added.Clinical course was updated and text was amended accordingly.Additional information was received on 08-jan-2019 from lawyer.Upon internal review on 11-jan-2019, the case was upgraded to serious from non-serious (seriousness criteria of device malfunction as medically significant added).Classification added.Additional information received on 15-mar-2019 from lawyer.Medical history of pain, infection of prostate tubes, contact dermatitis rash, bilateral osteoarthritis, knee pain, mucus coming out, bad cough, joint aches, pain in both shoulders and pain in legs.Clinical course updated.Text amended accordingly.
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Search Alerts/Recalls
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