| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Sepsis (2067); Weakness (2145); Chills (2191); Discomfort (2330); Arthralgia (2355); Joint Swelling (2356); Disability (2371); Joint Disorder (2373); Joint Dislocation (2374); Weight Changes (2607); Alteration In Body Temperature (2682); No Code Available (3191)
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| Event Date 12/07/2017 |
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Event Type
Injury
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Event Description
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Pseudosepsis reaction following synvisc one injection [pseudosepsis] ([residual pain], [inflammatory reaction]), uses a walker for ambulation [walker user] , wheelchair for transportation [wheelchair user], prosthetic joint infection [joint infection], device malfunction [device malfunction], left knee discomfort [discomfort in joints], left knee discomfort with weight bearing activities and stair climbing [weight bearing difficulty], burning in the lower left extremity/ burning in the bilateral feet [burning sensation], swelling in the leg has improved/ heavy swelling to her foot and ankles [swelling of legs], c reactive protein high [c-reactive protein result high], erythrocyte sedimentation rate high [erythrocyte sedimentation rate high], aspiration of knee [effusion (l) knee], gained weight [weight gain], no longer able to use elliptical machine [inadequate exercise].Case narrative: this unsolicited case from united states was received on 10-may-2018 from physician.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after 3 days, developed c reactive protein high, erythrocyte sedimentation rate high; after 27 days patient experienced pseudosepsis reaction and after unknown latency, developed prosthetic joint infection, uses a walker for ambulation, wheelchair for transportation, left knee discomfort, left knee discomfort with weight bearing activities and stair climbing, burning in the lower left extremity/ burning in the bilateral feet, swelling in the leg has improved/ heavy swelling to her foot and ankles, aspiration of knee, gained weight and no longer able to use elliptical machine.A device malfunction was identified in the reported lot number.No relevant past drugs were reported.Patient had undergone left valve surgery on groin, c4 corpectomy, ankle/foot surgery (2002) neuromas removed in left foot, back/spine surgery - cervical laminectomy, back/spine surgery - spinal fusion, ovary removal both, head or neck surgery - brain surgery--aneurism repair complicated by cva, hysterectomy.Patient had stroke, thyroid problems, left hemiparesis, left knee pain, eye irritation, sinus problems, snoring, known heart murmur, sleep apnea, gerd, urinary loss of control, muscle aches, aches, weakness, arthralgia, back pain, rash, abdominal mole, cold intolerance, itching, runny nose and osteoarthritis of knee.Concomitant medications included diazepam, econazole, ergocalciferol, estradiol (estrace), folic acid, gabapentin, hydrocodone/paracetamol (acetaminophen w/hydrocodone), levothyroxine sodium (levothyroxine), tramadol hydrochloride (tramadol) and trospium.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once for osteoarthritis of knee and bilateral knee pain (lot no.7rsl021 and expiration number 31-may-2020).On an unknown date, after an unknown latency, patient experienced prosthetic joint infection, uses a walker for ambulation, wheelchair for transportation, left knee discomfort, left knee discomfort with weight bearing activities and stair climbing, burning in the lower left extremity/ burning in the bilateral feet, swelling in the leg has improved/ heavy swelling to her foot and ankles, aspiration of knee, gained weight and no longer able to use elliptical machine.On (b)(6) 2017, 3 days after initiating treatment, patient had c reactive protein high and erythrocyte sedimentation rate high.On (b)(6) 2017, 27 days after initiating treatment, patient developed pseudosepsis reaction was hospitalized for a few days in new mexico after receiving an injection.On (b)(6) 2018, patient was still having a lot of pain and it was hard to bear weight or climb stairs and says her condition was worse because of the injection.Patient was already requesting records and was looking for documentation to show that this all happened due to injection.Patient experienced pseudosepsis rxn requiring hospitalization.Continues to experience a great deal of discomfort and significant pain as of (b)(6) 2018.Patient continues to have left knee discomfort after receiving a synvisc injection to the knee on (b)(6) 2017.Patient was no longer able to use her elliptical machine.Patient also gained weight and had burning in the lower left extremity.The swelling in the leg improved.Patient was currently taking nothing for analgesia.Patient continues to use a walker and a wheelchair.After discussion of the risks and benefits, the patient elected to proceed with an aspiration of the left knee(s).Informed consent was obtained.There was no erythema, or warmth, and the skin was clear.The skin was prepped in the usual sterile fashion with betadine.A 18 gauge needle was inserted into the joint via a superolateral approach.The joint was then aspirated and 20 cc of normal appearing fluid was obtained.The fluid was carefully placed into the appropriate vials, labelled and sent to the lab for analysis.The injection was completed without complication, and a bandage was applied.The patient tolerated the procedure well and was instructed to avoid strenuous activity for the next 24-48 hours and to use ice, nsaids, or tylenol for pain as needed.Patient was given a prescription for norco to help with her pain control.She was given prescription for lab work.Patient was discharged with sulfarnethocazole, trimethoprim, hydrocodone, acetarninophen medications.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: hospitalization or prolongation for pseudosepsis reaction following synvisc one injection; important medical event for prosthetic joint infection and device malfunction; disability for uses a walker for ambulation and wheelchair for transportation.Additional information received on 29-may-2018.No new information received.
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Event Description
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Pseudosepsis reaction following synvisc one injection [pseudosepsis] ([residual pain], [inflammatory reaction]) uses a walker for ambulation [walker user] left hemiparesis [hemiparesis (left)] wheelchair for transportation [wheelchair user] prosthetic joint infection [joint infection] device malfunction [device malfunction] left knee discomfort [discomfort in joints] left knee discomfort with weight bearing activities and stair climbing [weight bearing difficulty] burning in the lower left extremity/ burning in the bilateral feet [burning sensation] swelling in the leg has improved/ heavy swelling to her foot and ankles [swelling of legs] c reactive protein high [c-reactive protein result high] erythrocyte sedimentation rate high [erythrocyte sedimentation rate high] aspiration of knee/ 20 cc of normal appearing fluid was obtained [effusion (l) knee] gained weight [weight gain] no longer able to use elliptical machine [inadequate exercise] transient left leg weakness [weakness of limbs] leg swelling/ swelling from the groin all the way down to her foot [swelling of limbs] behavioral change [abnormal behaviour] body mass index (36-36.9) [body mass index] she felt chilled [chills] synovial fluid color yellow [synovial fluid color] synovial fluid clarity hazy [synovial fluid analysis abnormal] synovial fluid wbc 129/ neutrophils 2/ monocytes 68/ lymphocytes 30 [synovial fluid white blood cells positive] synovial fluid rbc 2000 [synovial fluid red blood cells positive] unable to climb stairs [walking difficulty].Case narrative: this unsolicited legal case from united states was received on(b)(6) 2018 from physician.This case involves a 64 years old female patient who experienced pseudosepsis reaction following synvisc one injection, uses a walker for ambulation, wheelchair for transportation, prosthetic joint infection, device malfunction, left knee discomfort, left knee discomfort with weight bearing activities and stair climbing, burning in the lower left extremity/ burning in the bilateral feet, swelling in the leg has improved/ heavy swelling to her foot and ankles, c reactive protein high, erythrocyte sedimentation rate high, aspiration of knee/ 20 cc of normal appearing fluid was obtained, gained weight, no longer able to use elliptical machine, transient left leg weakness, left hemiparesis, leg swelling/ swelling from the groin all the way down to her foot, behavioral change, body mass index (36-36.9), she felt chilled (latency: unknown), synovial fluid color yellow, synovial fluid clarity hazy, synovial fluid wbc 129/ neutrophils 2/ monocytes 68/ lymphocytes 30, synovial fluid rbc 2000 (latency: 2 months) and unable to climb stairs (latency: unknown), after she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Patient's past medical history included left valve surgery on groin, c4 corpectomoy, ankle/foot surgery(2002) neuromas removed in left foot, back/spine surgery - cervical laminectomy, back/spine surgery - spinal fusion, ovary removal both, head or neck surgery - brain surgery--anuerism repair complicated by cva, hysterectomy.Patient had stroke, thyroid problems, left hemiparesis, left knee pain, eye irritation, sinus problems, snoring, known heart murmur, sleep apnea, gerd, urinary loss of control, muscle aches, aches, weakness, arthralgia, back pain, rash, abdominal mole, cold intolerance, itching, runny nose and osteoarthritis of knee, aneurysm, hyperglycaemia, hypercholesterolaemia, gestational diabetes, hypothyroidism, micturition urgency, obesity, back/shoulder pain, nasal congestion, cough loose and aching.Also, the past history included having metal in the body (titanium plates and 4 screws c4 corpectomy).Ptient had a past history of using cane.The patient had drug hypersensitivity with from codeine which causes nausea; drug hypersensitivity from trimethoprim, sulfamethoxazole (bactrim), biaxin and vicodin.The patient was reported to be an non-smoker who abstained from alcohol.The patient was postmenopausal.Patient's past drugs included synvisc one injection on 03-may-2017.Patient had a family history of her mother having arthritis.Concomitant medications included diazepam, econazole, ergocalciferol, estradiol (estrace), folic acid, gabapentin, hydrocodone/paracetamol (acetaminophen w/hydrocodone), levothyroxine sodium (levothyroxine), tramadol hydrochloride (tramadol), trospium, baclofen (baclofen); acetylsalicylic acid (aspirin); thyroid (armour thyroid); estrogens esterified; methyltestosterone (estrogens esterified; methyltestosterone); calcium (calcium); vitamin d2 (vitamin d2); lidocaine (lidocaine 5% extra); oxybutynin chloride (oxybutynin chloride); azithromycin (zithromax); metformin and aciclovir (zovirax).On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once for osteoarthritis of knee and bilateral knee pain (lot no.7rsl021 and expiration number 31-may-2020).The knee was cleansed with betadine and using aseptic technique was injected with synvisc one.Patient tolerated the injection well.Patient was advised to ice the knee 2-3 times for 15 minutes.On an unknown date, after an unknown latency, patient experienced prosthetic joint infection, uses a walker for ambulation, wheelchair for transportation, left knee discomfort, left knee discomfort with weight bearing activities and stair climbing, burning in the lower left extremity/ burning in the bilateral feet, swelling in the leg has improved/ heavy swelling to her foot and ankles/ swelling from the groin all the way down to her foot, aspiration of knee, gained weight and no longer able to use elliptical machine.On (b)(6) 2017, 3 days after initiating treatment, patient had c reactive protein high and erythrocyte sedimentation rate high.It was reported that the pati9ent developed a pseudo-septic reaction.Was hospitalized for 4 days.Knee aspirate cultures were negative.The patient had increased swelling in the left lower leg following the injection which slowly improved.The patient continued to use cane.Tylenol was taken ad needed for discomfort.The patoent complained of burning in bilateral feet which was more intense following the synvisc injection.On (b)(6) 2017, 27 days after initiating treatment, patient developed pseudosepsis reaction was hospitalized for a few days in new mexico after receiving an injection.The patient was discouraged from pursuing hyaluronic acid ij=njection following the pseudo-septic reaction.The degenerative nature of the osteoarthritis was discussed.The poatient was given a short course of neurotin to address the nerve pain.On (b)(6) 2018, patient was still having a lot of pain and it was hard to bear weight or climb stairs and says her condition was worse because of the injection.Patient was already requesting records and was looking for documentation to show that this all happened due to injection.Patient experienced psudosepsis rxn requiring hospitalization.Continues to experience a great deal of discomfort and significant pain as of(b)(6) 2018.Patient continues to have left knee discomfort after receiving a synvisc injection to the knee on (b)(6) 2017.Patient was no longer able to use her elliptical machine.Patient also gained weight and had burning in the lower left extremity.The swelling in the leg improved.Patient was currently taking nothing for analgesia.Patient continues to use a walker and a wheelchair.After discussion of the risks and benefits, the patient elected to proceed with an aspiration of the left knee(s).Informed consent was obtained.There was no erythema, or warmth, and the skin was clear.The skin was prepped in the usual sterile fashion with betadine.A 18 gauge needle was inserted into the joint via a superolateral approach.The joint was then aspirated and 20 cc of normal appearing fluid was obtained.The fluid was carefully placed into the appropriate vials, labelled and sent to the lab for analysis.The injection was completed without complication, and a bandage was applied.The patient tolerated the procedure well and was instructed to avoid strenuous activity for the next 24-48 hours and to use ice, nsaids, or tylenol for pain as needed.Patient was given a prescription for norco to help with her pain control.She was given prescription for lab work.Patient was discharged with sulfarnethocazole, trimethoprim, hydrocodone, acetarninophen medications.On an unknown date, the patient developed transient left leg weakness, left hemiparesis, behavioral change, body mass index (36-36.9), she felt chilled and unable to climb stairs.On (b)(6) 2018, synovial fluid examination was done which revealed synovial fluid color yellow, synovial fluid clarity hazy, synovial fluid wbc 129/ neutrophils 2/ monocytes 68/ lymphocytes 30 and synovial fluid rbc 2000.It was reported that the patient has neurogenic gait due to the underlying condition of osteoarthritis.On the left the patient had no effusion with 2+ medial and 3+ lateral joint line tenderness.2+left pes tenderness.Full range of motion of the hip without pain.Distal lower extremity erythema and edema.It was reported that the treatment optiond for her left knee were discussed which included the eventual need for left total knee arthroplasty.Cortisone injection was discussed but she is hesitant to have any further injections to the knee.The patient was given a prescription for outpatient physical therapy to address strengthening program for the knee.Corrective treatment: ice, nsaids, tylenol, to avoid strenuous activity for residual pain and tylenol for left knee discomfort and not reported for rest all the events outcome: recovering / resolving for swelling in the leg has improved/ heavy swelling to her foot and ankles and leg swelling/ swelling from the groin all the way down to her foot; unknown for rest all the events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: hospitalization or prolongation for pseudosepsis reaction following synvisc one injection; medically significant for prosthetic joint infection and device malfunction, hemiparesis; disability for uses a walker for ambulation and wheelchair for transportation.Additional information received on 29-may-2018.No new information received.Additional information was received on 07-aug-2018.New events of transient left leg weakness, left hemiparesis, , leg swelling/ swelling from the groin all the way down to her foot, behavioral change, body mass index (36-36.9), she felt chilled, synovial fluid color yellow, synovial fluid clarity hazy, synovial fluid wbc 129/ neutrophils 2/ monocytes 68/ lymphocytes 30, synovial fluid rbc 2000 and unable to climb stairs were added with details.Corrective of residual; pain and left knee discomfort were updated.Outcome of swelling in the leg has improved/ heavy swelling to her foot was updated from unknown to recovering.Concomitant medications of baclofen (baclofen); acetylsalicylic acid (aspirin); thyroid (armour thyroid); estrogens esterified; methyltestosterone (estrogens esterified; methyltestosterone); calcium (calcium); vitamin d2 (vitamin d2); lidocaine (lidocaine 5% extra); oxybutynin chloride (oxybutynin chloride); azithromycin (zithromax); and aciclovir (zovirax) were added and medical history of the patient was updated.Clinical course was updated.Text was amended accordingly.Follow up was received on 16-aug-2018.No new information was received.Additional information was received on 08-jan-2019 via counsel.Medical history was added.Concomitant medications were added.Clinical course updated and text amended accordingly.
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Event Description
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Pseudosepsis reaction following synvisc one injection [pseudosepsis] ([residual pain], [inflammatory reaction]) uses a walker for ambulation [walker user] wheelchair for transportation [wheelchair user] prosthetic joint infection [joint infection] device malfunction [device malfunction] left knee discomfort [discomfort in joints] left knee discomfort with weight bearing activities and stair climbing [weight bearing difficulty] burning in the lower left extremity/ burning in the bilateral feet [burning sensation] swelling in the leg has improved/ heavy swelling to her foot and ankles [swelling of legs] c reactive protein high [c-reactive protein result high] erythrocyte sedimentation rate high [erythrocyte sedimentation rate high] aspiration of knee/ 20 cc of normal appearing fluid was obtained [effusion (l) knee] gained weight [weight gain] no longer able to use elliptical machine [inadequate exercise] transient left leg weakness [weakness of limbs] left hemiparesis [hemiparesis (left)] leg swelling/ swelling from the groin all the way down to her foot [swelling of limbs] behavioral change [abnormal behaviour] body mass index (36-36.9) [body mass index] she felt chilled [chills] synovial fluid color yellow [synovial fluid color] synovial fluid clarity hazy [synovial fluid analysis abnormal] synovial fluid wbc 129/ neutrophils 2/ monocytes 68/ lymphocytes 30 [synovial fluid white blood cells positive] synovial fluid rbc 2000 [synovial fluid red blood cells positive] unable to climb stairs [walking difficulty].Case narrative: this unsolicited case from united states was received on (b)(6) 2018 from physician.This case involves a 64 years old female patient who experienced pseudosepsis reaction following synvisc one injection, uses a walker for ambulation, wheelchair for transportation, prosthetic joint infection, device malfunction, left knee discomfort, left knee discomfort with weight bearing activities and stair climbing, burning in the lower left extremity/ burning in the bilateral feet, swelling in the leg has improved/ heavy swelling to her foot and ankles, c reactive protein high, erythrocyte sedimentation rate high, aspiration of knee/ 20 cc of normal appearing fluid was obtained, gained weight, no longer able to use elliptical machine, transient left leg weakness, left hemiparesis, leg swelling/ swelling from the groin all the way down to her foot, behavioral change, body mass index (36-36.9), she felt chilled (latency: unknown), synovial fluid color yellow, synovial fluid clarity hazy, synovial fluid wbc 129/ neutrophils 2/ monocytes 68/ lymphocytes 30, synovial fluid rbc 2000 (latency: 2 months) and unable to climb stairs (latency: unknown), after she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).No relevant past drugs were reported.Patient had undergone left valve surgery on groin, c4 corpectomoy, ankle/foot surgery(2002) neuromas removed in left foot, back/spine surgery - cervical laminectomy, back/spine surgery - spinal fusion, ovary removal both, head or neck surgery - brain surgery--anuerism repair complicated by cva, hysterectomy.Patient had stroke, thyroid problems, left hemiparesis, left knee pain, eye irritation, sinus problems, snoring, known heart murmur, sleep apnea, gerd, urinary loss of control, muscle aches, aches, weakness, arthralgia, back pain, rash, abdominal mole, cold intolerance, itching, runny nose and osteoarthritis of knee, aneurysm, hyperglycaemia, hypercholesterolaemia, gestational diabetes, hypothyroidism, micturition urgency, obesity, back/shoulder pain, nasal congestion, cough loose and aching.The patient had drug hypersensitivity with from codeine which causes nausea, trimethoprim and sulfamethoxazole (bactrim).The patient was reported to be an ex-smoker who abstained from alcohol.The patient was postmenopausal.Concomitant medications included diazepam, econazole, ergocalciferol, estradiol (estrace), folic acid, gabapentin, hydrocodone/paracetamol (acetaminophen w/hydrocodone), levothyroxine sodium (levothyroxine), tramadol hydrochloride (tramadol), trospium, baclofen (baclofen); acetylsalicylic acid (aspirin); thyroid (armour thyroid); estrogens esterified; methyltestosterone (estrogens esterified; methyltestosterone); calcium (calcium); vitamin d2 (vitamin d2); lidocaine (lidocaine 5% extra); oxybutynin chloride (oxybutynin chloride); azithromycin (zithromax); and aciclovir (zovirax).On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once for osteoarthritis of knee and bilateral knee pain (lot no.7rsl021 and expiration number 31-may-2020).The knee was cleansed with betadine and using aseptic technique was injected with synvisc one.Patient tolerated the injection well.On an unknown date, after an unknown latency, patient experienced prosthetic joint infection, uses a walker for ambulation, wheelchair for transportation, left knee discomfort, left knee discomfort with weight bearing activities and stair climbing, burning in the lower left extremity/ burning in the bilateral feet, swelling in the leg has improved/ heavy swelling to her foot and ankles/ swelling from the groin all the way down to her foot, aspiration of knee, gained weight and no longer able to use elliptical machine.On (b)(6) 2017, 3 days after initiating treatment, patient had c reactive protein high and erythrocyte sedimentation rate high.It was reported that the pati9ent developed a pseudo-septic reaction.Was hospitalized for 4 days.Knee aspirate cultures were negative.The patient had increased swelling in the left lower leg following the injection which slowly improved.The patient continued to use cane.Tylenol was taken ad needed for discomfort.The patoent complained of burning in bilateral feet which was more intense following the synvisc injection.On (b)(6) 2017, 27 days after initiating treatment, patient developed pseudosepsis reaction was hospitalized for a few days in new mexico after receiving an injection.The patient was discouraged from pursuing hyaluronic acid ij=njection following the pseudo-septic reaction.The degenerative nature of the osteoarthritis was discussed.The poatient was given a short course of neurotin to address the nerve pain.On (b)(6) 2018, patient was still having a lot of pain and it was hard to bear weight or climb stairs and says her condition was worse because of the injection.Patient was already requesting records and was looking for documentation to show that this all happened due to injection.Patient experienced psudosepsis rxn requiring hospitalization.Continues to experience a great deal of discomfort and significant pain as of (b)(6) 2018.Patient continues to have left knee discomfort after receiving a synvisc injection to the knee on (b)(6) 2017.Patient was no longer able to use her elliptical machine.Patient also gained weight and had burning in the lower left extremity.The swelling in the leg improved.Patient was currently taking nothing for analgesia.Patient continues to use a walker and a wheelchair.After discussion of the risks and benefits, the patient elected to proceed with an aspiration of the left knee(s).Informed consent was obtained.There was no erythema, or warmth, and the skin was clear.The skin was prepped in the usual sterile fashion with betadine.A 18 gauge needle was inserted into the joint via a superolateral approach.The joint was then aspirated and 20 cc of normal appearing fluid was obtained.The fluid was carefully placed into the appropriate vials, labelled and sent to the lab for analysis.The injection was completed without complication, and a bandage was applied.The patient tolerated the procedure well and was instructed to avoid strenuous activity for the next 24-48 hours and to use ice, nsaids, or tylenol for pain as needed.Patient was given a prescription for norco to help with her pain control.She was given prescription for lab work.Patient was discharged with sulfarnethocazole, trimethoprim, hydrocodone, acetarninophen medications.On an unknown date, the patient developed transient left leg weakness, left hemiparesis, behavioral change, body mass index (36-36.9), she felt chilled and unable to climb stairs.On (b)(6) 2018, synovial fluid examination was done which revealed synovial fluid color yellow, synovial fluid clarity hazy, synovial fluid wbc 129/ neutrophils 2/ monocytes 68/ lymphocytes 30 and synovial fluid rbc 2000.It was reported that the patient has neurogenic gait due to the underlying condition of osteoarthritis.On the left the patient had no effusion with 2+ medial and 3+ lateral joint line tenderness.2+left pes tenderness.Full range of motion of the hip without pain.Distal lower extremity erythema and edema.It was reported that the treatment optiond for her left knee were discussed which included the eventual need for left total knee arthroplasty.Cortisone injection was discussed but she is hesitant to have any further injections to the knee.The patient was given a prescription for outpatient physical therapy to address strengthening program for the knee.Corrective treatment: ice, nsaids, tylenol, to avoid strenuous activity for residual pain and tylenol for left knee discomfort and not reported for rest all the events outcome: recovering / resolving for swelling in the leg has improved/ heavy swelling to her foot and ankles and leg swelling/ swelling from the groin all the way down to her foot; unknown for rest all the events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: hospitalization or prolongation for pseudosepsis reaction following synvisc one injection; important medical event for prosthetic joint infection and device malfunction; disability for uses a walker for ambulation and wheelchair for transportation.Additional information received on 29-may-2018.No new information received.Additional information was received on 07-aug-2018.New events of transient left leg weakness, left hemiparesis, , leg swelling/ swelling from the groin all the way down to her foot, behavioral change, body mass index (36-36.9), she felt chilled, synovial fluid color yellow, synovial fluid clarity hazy, synovial fluid wbc 129/ neutrophils 2/ monocytes 68/ lymphocytes 30, synovial fluid rbc 2000 and unable to climb stairs were added with details.Corrective of residual; pain and left knee discomfort were updated.Outcome of swelling in the leg has improved/ heavy swelling to her foot was updated from unknown to recovering.Concomitant medications of baclofen (baclofen); acetylsalicylic acid (aspirin); thyroid (armour thyroid); estrogens esterified; methyltestosterone (estrogens esterified; methyltestosterone); calcium (calcium); vitamin d2 (vitamin d2); lidocaine (lidocaine 5% extra); oxybutynin chloride (oxybutynin chloride); azithromycin (zithromax); and aciclovir (zovirax) were added and medical history of the patient was updated.Clinical course was updated.Text was amended accordingly.Follow up was received on 16-aug-2018.No new information was received.
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