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Drained both knees [joint effusion].Knees swelled to the point [knee swelling] ([unable to walk]).Lot # 7rsl021 may have been contaminated with bacteria [device malfunction].High fever [fever] ([chills], [sweating]).Was up all night [sleep difficult].Case narrative: initial information received on 23-may-2018 regarding an unsolicited valid serious case from united states received from a consumer/non-hcp.This case involves an unknown age patient who experienced high fever (pyrexia), knees swelled to the point (joint swelling), drained both knees (joint effusion), was up all night (sleep difficult) and lot # 7rsl021 may have been contaminated with bacteria (device malfunction) while he/she using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2018, the patient started using synvisc one with (dosage: unknown; route of administration: intra-articular; unknown: frequency; batch number: 7rsl021) for bio surgery.On (b)(6) 2018, patient reported that severe reaction later that day, both knees swelled to the point that he could not walk, he had a high fever, sweats, chills, and was up all night.Next morning, he went to ortho er where they drained both knees and gave him some steroids.Patient also reported that he got information that lot # 7rsl021 may have been contaminated with bacteria.No further information provided.Final diagnosis was drained both knees, severe knees swelled to the point and insomnia.Seriousness criteria: medically significant for severe knees swelled to the point and intervention required for drained both knees and device malfunction.Corrective treatment: steroids for drained both knees; not reported for other events.Outcome: unknown for all the events.A pharmaceutical technical complaint was initiated on 15-jun-2018 for synvisc one (lot number: 7rsl021) 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.Reporter's causality: not reported for all the events.Follow up was received on 15-jun-2018.Global ptc number was added.
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Lot # 7rsl021 may have been contaminated with bacteria [device malfunction] , patient's knees started to become stiff and then progressively worse to the point where he was unable to bear weight [weight bearing difficulty], could not walk [unable to walk], drained left knee/3+effusion of left knee/aspirated with 40 ml of cloudy fluid from left knee [joint effusion], both knees swelled to the point that he could not walk [swelling of l knee], patient's knees started to become stiff and then progressively worse to the point where he was unable to bear weight [joint stiffness], pain terminally straightening th left knee and bending of left knee beyond 90 degrees [aching (l) knee], was up all night [sleep difficult], aspirated with 40 ml of cloudy fluid from left knee [synovial fluid analysis abnormal] high fever [fever] ([chills], [sweating]), left knee warm [joint warmth].Case narrative: the case is cross-referenced to (b)(4) (multiple devices).Initial information received on 23-may-2018 regarding an unsolicited valid legal serious case from united states received from a consumer/non-hcp.This case involves a 48 year old male patient who experienced high fever, both knees swelled to the point that he could not walk, drained left knee/3+effusion of left knee/aspirated with 40 ml of cloudy fluid from left knee, was up all night, lot # 7rsl021 may have been contaminated with bacteria (latency unknown), patient's knees started to become stiff and then progressively worse to the point where he was unable to bear weight (latency: same day), aspirated with 40 ml of cloudy fluid from left knee, pain terminally straightening the left knee and bending of left knee beyond 90 degrees, left knee warm (latency: 1 day) after using medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included right knee effusion, knee pain/pain in the medial aspect of left knee/pain in the anterior medial aspect of his right knee/increased pain after walk, complaints to his right wrist/soreness on valor aspect of wrist/pain worsened in wrist (pain was aching and stabbing in nature, moderate in intensity), right wrist injury ((b)(6) 2015), right wrist was 1+ soft tissue swelling, limping since onset of left medial knee pain, nighttime symptoms that keep him from sleeping restfully, pain with sitting and stair climbing/problems with stair climbing and kneeling as well as squatting and describes it as aching sensation due to which patient was unable to run, meniscus tear of left knee/meniscus tear of right knee, right knee arthroscopy and partial medial meniscectomy of right knee ((b)(6) 2010), swelling in the right knee/increased swelling after walk, gout which affected his left foot at (b)(6) 2009, mri ((b)(6) 2014- left knee mri and (b)(6) 2010- right knee mri), patellofemoral syndrome, chondromalacia of the medial femoral condyle, right knee, ongoing osteoarthritis of both knees/significant degenerative arthritis over the medial compartment and patellofemoral compartments.The patient's family history included lung cancer.Patient had no known drug allergies.The patient received synvisc one injections in the past on (b)(6) 2014 (in left knee), (b)(6) 2014 (bilateral), (b)(6) 2015 (bilateral), (b)(6) 2016 (bilateral) and tolerated them very well.Patient's past vaccination(s) were not provided.On (b)(6) 2017, the patient received hylan g-f 20, sodium hyaluronate (synvisc one) in left knee (dosage: unknown) via intra-articular route, once, (batch number: 7rsl021) for osteoarthritis.On (b)(6) 2017, when he got home from the injections, in the night, patient's knees started to become stiff (assessed serious as required intervention) and then progressively worse to the point where he was unable to bear weight (caused disability) (latency: same day).On an unknown date, patient reported that severe reaction later that day, both knees swelled (required intervention) to the point that he could not walk (caused disability), he had a high fever, sweats, chills, and was up all night (latency: unknown).Patient also reported that he got information that lot # 7rsl021 may have been contaminated with bacteria.On (b)(6) 2017, 1 day later, patient came in wheelchair, complaining of agony in his knees.He was having pain terminally strengthening the knees and bending the knees beyond 90 degrees (assessed serious as required intervention) (1 day later).His knees were warm but no erythema or signs of infection and he also denied calf pain.It was thought that he was having reaction to the synvisc one.He was neurovascularly intact distally.On same day, he was aspirated (serious as required intervention) with 40 ml of cloudy fluid from left knee (1 day later), and then injected with 80 mg of depo-medrol and 2 ml of 1% lidocaine via same portal.The patient tolerated the aspiration injection well.Patient was then placed in compression stockings and was prescribed for indomethacin 50 mg, which he was going to take for the next 2 to 3 days and was going for follow up with physician as scheduled.He would continue with cold therapy and modified activity.Action taken: not applicable for all events.Corrective treatment: steroids (dopo-medrol) for drained left knee/3+effusion of left knee/aspirated with 40 ml of cloudy fluid from left knee, both knees swelled to the point that he could not walk, patient's knees started to become stiff and then progressively worse to the point where he was unable to bear weight, pain terminally straightening the left knee and bending of left knee beyond 90 degrees, lot # 7rsl021 may have been contaminated with bacteria, wheelchair for both knees swelled to the point that he could not walk, patient's knees started to become stiff and then progressively worse to the point where he was unable to bear weight; not reported for rest all events.Outcome: unknown for all the events.A pharmaceutical technical complaint was initiated on 15-jun-2018 for synvisc one (lot number: 7rsl021) 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.Follow up was received on 15-jun-2018.Global ptc number was added.Additional information received on 07-oct-2019 from lawyer.As reported term updated to drained left knee/3+effusion of left knee/aspirated with 40 ml of cloudy fluid from left knee.Medical history added.Events of aspirated with 40 ml of cloudy fluid from left knee, patient's knees started to become stiff and then progressively worse to the point where he was unable to bear weight, pain terminally straightening the left knee and bending of left knee beyond 90 degrees, left knee warm were added.Case classification updated to legal case.Related case id added.Corrective treatment added.Clinical course updated and text amended accordingly.
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