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Based on additional information received on 21-feb- 2018, this case became medically confirmed.This unsolicited case from united states was received on 12-jan-2018 from a other non-healthcare professional.This case concerns a (b)(6) female patient who received treatment with synvisc one and after 2 days the patient had difficulty weight bearing, stiffness, right knee swelling, increasing pain/increased pain, joint effusion, chills; also, device malfunction was identified for the reported lot number.No past drug, concomitant medication was provided.The patient had history of right knee osteoarthritis, tear of medial meniscus, current injury, right knee, initial encounter.On (b)(6) 2017, the patient had sport injury (she fell playing soccer and injured her knee).On (b)(6) 2017, it was reported that the patient had right knee osteoarthritis.The previous injection site was healed today.Gross distal neurologic function appeared to be intact.Upon inspection there was no erythema.The patient was experiencing joint line tenderness as well.The patient presented to clinic in no acute distress, afebrile, nontoxic appearing.Skin to the right knee was intact.No signs or symptoms of infection.Her calf was soft and supple non-tender.Distal capillary refill and sensation was intact.Right knee was prepped sterilely with betadine and alcohol.On the same day, the patient initiated treatment with single intra-articular synvisc one injection, once (batch/lot number: 7rsl021; expiry date: not reported) for right knee osteoarthritis.It was reported that synvisc one injection was given without incident.The patient tolerated well.Sterile bandage was applied.It was reported that the patient's knee was better after the steroid injection.The patient would continue with her home exercise program.Anti-inflammatory prior to activities.No further treatment was indicated for this patient at this time.Visco supplementation injection was given.On (b)(6) 2018 (2 days after first dose of alemtuzumab), the patient noticed pain and swelling later in the day after her synvisc one injection.The next day she could not bear any weight.The patient had some chills, but no fevers.Present symptoms were pain level (0-10): 8/10, pain quality was sharp, aggravating factors were weight bearing, squatting, kneeling, stairs; alleviating factors were rest; worst time was activity, progression: same; associated symptoms were popping, clicking, grinding, rom restriction, swelling.Review of systems general revealed complains of chills, denies fevers, sweats; eyes: denied blurring.Ears/nose/throat: denied earache; cardiovascular: denied chest pains, palpitations; respiratory: denied cough, dyspnea; gastrointestinal: denied nausea, vomiting, diarrhea.Musculoskeletal: complained of joint pain, joint swelling, stiffness, denied back pain; skin: denied rash, itching, dryness; neurologic: denied paresthesias.Allergic/immunologic: denied hay fever.Physical exam showed general appearance: well developed, well nourished, no acute distress.Peripheral vascular.Inspection/palpation: normal pulses/temperature.Gait and station inspection: antalgic.Neurologic sensation: intact to touch; mental status exam orientation: oriented to time, oriented to place, oriented to person mood and affect: no depression, no anxiety, no agitation; knee exam showed that the patient presented to clinic in no acute distress, afebrile, nontoxic appearing.She ambulated with an antalgic gait to the right lower extremity.Skin to the right knee was intact.Large joint effusion was appreciated.No increased temperature was appreciated.Limited range of motion secondary to pain and joint effusion.Distal capillary refill and sensation was intact.Risks, benefits, alternatives to joint aspiration were discussed with the patient consent was obtained.The right knee was prepped sterilely with betadine and alcohol.80 cc of a yellowish-green murky fluid consistent with inflammatory effusion was aspirated (joint effusion).Sterile bandage was applied.Current problems (prior to update): osteoarthritis of right knee.Other tear of medial meniscus, current injury, right knee, initial encounter.Plan was to start new medications: ibuprofen 800 mg oral tablet (ibuprofen) one oral q8 hours with food.Taken after completing the medrol dosepak medrol 4 mg oral tablet therapy pack (methylprednisolone) tapering dose per product insert instructions.Other plans were to the patient will be given a medrol dosepak to be followed by ibuprofen.Activity modifications and restrictions discussed.And to reevaluate in 10-14 days.It was advised to call to the effusion recur.Disposition explanation/reassurance provided to patient.Return appointment in 10-14 days.On (b)(6)2017, the patient was in the office with joint effusion with increasing pain, stiffness, and difficulty bearing weight.Patient was administered methylprednisolone (medrol) dose pack.Chief complaint was of right knee, it was reported that knee was a lot better after the steroid pack.The patient had some swelling still.Present symptoms: pain level (0-10): 6/10, pain quality was dull, aggravating factors: weight bearing, squatting, kneeling, stairs, alleviating factors: rest, worst time: activity, progression: better, associated symptoms were: rom restriction, swelling, review of systems: general: denied fevers, chills (recovered on an unknown date in 2018), sweats, eyes: denied blurring.Ears/nose/throat: denied earache, nasal congestion, nosebleeds, sore throat.Cardiovascular: denied chest pains, palpitations, syncope.Respiratory: denied cough, dyspnea.Gastrointestinal: denied nausea, vomiting, diarrhea.Musculoskeletal: complains of stiffness.Denied back pain.Skin: denied rash, itching.Neurologic: denied paresthesias.Allergic/immunologic: denied hay fever.Physical exam showed general appearance: well developed, well nourished, no acute distress; neurologic sensation: intact to touch; mental status exam, orientation: oriented to time, oriented to place, oriented to person, mood and affect: no depression, no anxiety, no agitation.Knee exam showed that the patient presented to clinic in no acute distress, afebrile, nontoxic appearing.Skin to the right knee was intact.Effusion was significantly decreased.She has near full range of motion with some mild discomfort.Her calf was soft and supple nontender.Distal capillary refill and sensation was intact.Current problems (prior to update): osteoarthritis of right knee.Other tear of medial meniscus, current injury, right knee, initial encounter.Current medications (prior to update): ibuprofen 800 mg oral tablet (ibuprofen) one oral.Q8 hours with food taken after completing the medrol dosepak.Other plans were home exercise program.The patient would continue with her home exercises.Discussed anti-inflammatories.Heat and ice treatment.On (b)(6) 2018, the patient had follow-up visit for right knee osteoarthritis, chief complaint was of right knee.The patient's knee was much better.The patient did not have daily pain.Pain level (0-10): 0/10; progression: better; denied any associated symptoms.Review of systems; general: denied fevers, chills, sweats.Eyes: denied blurring.Ears/nose/throat: denied earache, nasal congestion, nosebleeds, sore throat.Cardiovascular: denied chest pains, palpitations.Respiratory: denied cough, dyspnea.Gastrointestinal: denied nausea, vomiting, diarrhea.Musculoskeletal: complains of stiffness.Denies back pain.Skin: denied rash, dryness.Allergic/immunologic: denied hay fever.Peripheral vascular inspection/palpation: normal pulses/temperature; gait and station inspection: normal; neurologic sensation: intact to touch; mental status exam showed orientation: oriented to time, oriented to place, oriented to person, mood and affect: no depression, no anxiety, no agitation.Knee exam showed the patient presented to clinic in no acute distress, afebrile, nontoxic appearing.She ambulated with a normal gait.Skin to the right knee was intact.Minimal joint effusion was appreciated.No erythema or increased temperature was noted.She has full range of motion from 0-135 with no significant pain.Some occasional clicking at the patellofemoral joint.Ligamentous exam was stable.Distal capillary refill and sensation was intact.The patient and her daughter were informed that the pharmaceutical company that made synvisc one notified a potential contamination a lot number that she received.The patient did develop what appeared to be still effusion after the injection was increasing pain, stiffness and joint effusion and difficulty bearing weight.She was seen 2 days after the injection.Was given a medrol dosepak followed by ibuprofen.It was informed the patient and her daughter that further details will be gathered regarding this potential contamination from the pharmaceutical company.Current problems (prior to update): osteoarthritis of right knee.Other tear of medial meniscus, current injury, right knee, initial.Other plans were home exercise program; plan comments: it was reported that follow up with a pharmaceutical company again.The patient would continue with her antiinflammatory as needed.Discussed natural anti-inflammatories.Work good supportive shoes.The patient would follow-up as needed, disposition return appointment: as needed.Corrective treatment: ibuprofen and methylprednisolone (medrol) for joint effusion, stiffness, joint effusion, right knee swelling, increasing pain/increased pain; not reported for chills outcome: unknown for joint effusion, right knee swelling, stiffness, difficulty weight bearing; recovered for chills a pharmaceutical technical complaint (ptc) was initiated with global ptc number 51972.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 criterion: required intervention for device malfunction and joint effusion follow up was received on 17-jan-2018.Global ptc number was added.Upon internal review on 21-feb-2018, previously reported events of difficulty weight bearing, stiffness, right knee swelling and increasing pain/increased pain were updated as diagnosis.Additional information was received on 21-feb-2018 from a healthcare professional (case became medically confirmed).The patient's age was updated.The patient's medical history and concurrent conditions were updated.The suspect drug's indication was updated from osteoarthritis to right knee osteoarthritis.Additional event of chills was added along with details.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 21-feb-2018.The follow up received does not change the previous assessment of the case.This case concerns a patient who received treatment with synvisc one and later experienced joint stiffness, weight bearing difficulty, joint effusion and knee pain from the recalled lot of synvisc one.Based on the event onset dates a significant temporal relationship can be established on the basis of reported information.Furthermore, 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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