| Lot Number 7RSL021 |
| Device Problem
Microbial Contamination of Device (2303)
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| Patient Problems
Bacterial Infection (1735); Chest Pain (1776); Erythema (1840); Fatigue (1849); Unspecified Infection (1930); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Loss of Range of Motion (2032); Swelling (2091); Hypoesthesia, Foot/Leg (2354); Arthralgia (2355); Joint Swelling (2356); Neck Pain (2433); Sleep Dysfunction (2517); No Code Available (3191)
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| Event Date 11/13/2017 |
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Event Type
Injury
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Event Description
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Device malfunction [device malfunction], swelling/left knee was double its normal size [knee swelling], hurts to walk/could not walk [difficulty in walking], joint infection [joint infection], excruciating pain/pain is worsened with activity [knee pain], congestion [congestion pulmonary], redness in left knee [redness], itching in eyes [itching eyes], cough [cough], sleep has been greatly affected [sleep difficult], sciatica had flared [sciatica aggravated], rom is limited due to the pain [joint range of motion decreased], t wave abnormality [electrocardiogram t wave abnormal], neuropathy type pain [neuropathic pain], knee was mildly warm [joint warmth], eosinophil percentage high [eosinophil percentage increased], bilirubin total low [bilirubin total low], alkaline phosphatase high [alkaline phosphatase increased], spasms [spasms], limited weightbearing [weight bearing difficulty], left knee effusion [knee effusion].Case narrative: based on additional information received on 04-jun-2018 from a health care professional, the case was medically confirmed.Also this case initially considered as non-serious was upgraded to serious as the serious events of device malfunction, excruciating pain, swelling/left knee was double its normal size (seriousness criteria: required intervention), hurts to walk/could not walk (seriousness criteria: disability) and joint infection (seriousness criteria: medically significant) were added.Initial information received on 12-feb-2018 regarding an unsolicited valid serious case from united states received from a lawyer.This case involves a (b)(6) female patient who was treated with hylan g-f 20, sodium hyaluronate (synvisc one) injection and on the same day had excruciating pain, swelling/ l knee was double its normal size and hurts to walk/could not walk, after 1 day had spasms and after 2 days had left knee effusion and after unknown latency sciatica had flared, congestion, cough, sleep has been greatly affected and itching eyes, after few days had redness in left knee, rom is limited due to the pain, joint infection, knee was slightly warm, had limited weightbearing and neuropathy type pain, after 1 month and 28 days ecg was abnormal, after 2 months and 06 days alkaline phosphatase high, bilirubin total low and eosinophil percentage high.Also device malfunction was reported for this lot number.Patient's medical history included acute constipation, lower mid abdominal pain, sciatica, arrhythmias, primary osteoarthritis of left knee, hallux rigidus of both feet, back pain, gait problem, neck pain, neck stiffness, acute medial meniscus tear, left, locking, catching, snapping, crepitus in left knee, anxiety (unspecified), decreased concentration, bipolar disorder (in partial remission, most recent episode depressed: since (b)(6) 2017), asthma (childhood after having pneumonia resolved after treatment), colitis unspecified (hospitalized on (b)(6) 2013), diverticulitis (hospitalized (b)(6) 2013), pneumonia, hypothyroid, unspecified, osteoarthritis, rheumatoid arthritis, cholecystectomy, cystourethroscopy ((b)(6) 2014), excision morton's neuroma ((b)(6) 2015), partial joint replacement ((b)(6) 2008), knee arthroscopy (1976), laparoscopic cholecystectomy, laparoscopic colectomy partial w/anastamosis ((b)(6) 2014).Other surgical history included tendonitis, 10% disability in wrists in 1980's, left shoulder-bursa removal also clavicle ((b)(6) 2007), right knee arthroscopy (1977), right knee surgery (partial knee replacement in 2008), right shoulder rotator cuff and clavicle repairs, tarsal tunnel in the right foot two repairs, transfer adjacent tissue hand (on (b)(6) 2016).Concurrent conditions included panic disorder with agoraphobia and panic attacks in partial remission, depression, hypertriglyceridemia, gastroesophageal reflux disease, chronic pain in left foot (since (b)(6) 2013), neuroma, morton's (since (b)(6) 2013), morton's neuroma of third interspaces of both feet (since (b)(6) 2017), other specified dermatosis (since (b)(6) 2015), right finger pain (since (b)(6) 2016), finger stiffness right (since (b)(6) 2017), acute medial meniscus tear, left, initial encounter, post right partial knee replacement ((b)(6) 2017).Patient was allergic to epinephrine hydrochloride (epinephrine) (shortness of breath) and oxycodone (itching).Patient was positive for environmental allergies and food allergies.Patient was never a smoker and did not use alcohol.Family history included breast cancer (maternal grandmother), cancer, depression, hypertension and stroke (mother), dementia, hypertension and stroke (father), diabetes type ii, hypertension and hyperlipidemia in sister.Past drug included tdap ((b)(6) 2015) and varicella (varivax) ((b)(6) 2012).Concomitant medications included paracetamol (tylenol), acetylsalicylic acid (aspirin ec), buspirone hydrochloride (buspar), clonazepam (klonopin), diphenhydramine hydrochloride (benadryl), esomeprazole sodium (nexium), chondroitin sulfate sodium, glucosamine hydrochloride (glucosamine/chondroitin (chondroitin sulfate sodium;glucosamine hydrochloride)), lithium, lorazepam, ascorbic acid, betacarotene, copper, glycine max extract, herbal oil nos, oryza sativa oil, vaccinium myrtillus, vitamin e nos, xantofyl, zeaxanthin, zinc (lutein complex), gemfibrozil (lopid), levothyroxine sodium (synthroid), potassium chloride, gabapentin (neurontin).On (b)(6) 2017, at 15:49, the patient received treatment with intra-articular hylan g-f 20, sodium hyaluronate injection from anterolateral portal using 20 gauge needle, at a dose: 16 mg, once (lot number: 7rsl021 and expiry date: not provided) in left knee for primary osteoarthritis of left knee and chronic pain of left knee after betadine/cold spray.On the same day, by 09:00 pm her left knee was double its normal size with excruciating pain worse than her baseline and patient's pain on pain score was 6.Pain was so severe that she could not walk.On (b)(6) 2017, patient had pain, swelling and it hurts to walk.On (b)(6) 2017, patient's musculoskeletal knee examination showed effusion in left knee without redness.Patient was on wheel chair.Patient was advised that this was an adverse reaction to synvisc one.Patient should not have any further injections.Patient should continue ice and limited weight bearing until the pain resolved.This level of pain lasted almost two weeks, then lessened slightly probably as patient was given an oral dose of prednisolone to help with the pain and swelling.Patient's pain score on the same day was 10.As of (b)(6) 2017, patient had complaints of continued pain, swelling, difficulty walking and redness.It was reported that the patient had received the contaminated synvisc-one.On (b)(6) 2018, patient had left knee x-ray and was diagnosed with chronic pain of left knee, tricompartmental degenerative arthritis with mild narrowing of the medial compartment and tricompartmental osteophytosis.Diffuse demineralization was noticed.There was significant arthritis in knee.There was bone on bone joint space narrowing and early osteophyte formation.On the same day, patient's c-reactive protein was 0.13 mg/dl (reference range: <=0.60 mg/dl).Patient's pain on pain scale was 6 on same day.On the same day, patient's left knee musculoskeletal examination showed flexion: 80, extension: 10 and effusion 1+.It was reported that the patient needed assistance for ambulation and was at high risk for falls.On an unknown date, after unknown latency, patient had congestion, cough and itching eyes.On (b)(6) 2018, patient's pain on pain scale was 7/10 on same day and was sharp.As of (b)(6) 2018, the pain had plateaued but at a level much higher than her previous baseline and had persisted to this day.Patient's left knee was very mildly effused medially, otherwise unremarkable appearance; mild tenderness to palpation medially and superior to patella; no excessive warmth.Intact passive rom, but pain inhibition noted during active rom.No lower extremity edema.It was reported that patient's sleep had been greatly affected, and her sciatica had flared as a result (onset date and latency: unknown).Pain was worsened with activity.On an unknown date, few days after the injection, range of motion (rom) is limited due to the pain.No fevers/chills/night seats (but was still going through menopause).Patient was not taking any pain medications (could not take non-steroidal anti-inflammatory disease due to liver issues, and paracetamol (tylenol) did not help at all).It was reported that patient was now with persistent worsened left knee pain following possibly contaminated (with methylobacterium thiocyanatum) synvisc one injection to her left knee.On the same day, aspiration was requested with samples sent for culture and cytology, but there was no fluid in the knee on aspiration attempt.Since the orthopedician could not completely exclude infection (joint infection) (onset date: unknown) in this case, patient would start course of oral levofloxacin (levaquin) 750mg bid for 14 days.On (b)(6) 2018, patient had electrocardiogram (ecg) and the result was abnormal.Nonspecific t wave abnormalities, anterolateral leads were now present.When compared with ecg of (b)(6) 2014, sinus rhythm had replaced sinus bradycardia.On an unknown date, after unknown latency, patient had neuropathy type pain.As of (b)(6) 2018, patient was not interested in pursuing anything more with her neuropathy type pain.Patient's pain score was 7 on the same day.On (b)(6) 2018, patient presented for aspiration of left knee for possible infection and fluid would be sent for cultures.Under sterile conditions, knee was attempted to be aspirated with ultrasound guidance but no fluid was able to be aspirated.Needle was withdrawn and site was cleaned and dressed.Patient's physical exam on the same day showed that the left knee was without redness.Knee was mildly warm with trace effusion.Patellar mobility normal.Unable to flex knee past 60 degrees due to discomfort but was keeping the knee straight.On the same day, ultrasound did not showed any collectible area of fluid but did show thickened synovium.Patient's pain was 8 on pain score.On (b)(6) 2018, patient's eosinophil% was: 9.5% (h) (normal range: 0-7.0), bilirubin total: 0.3 mg/dl (l) (normal range: 24-110), alkaline phosphatase: 122 u/l (h) (normal range: 3.5-4.8), corrective treatment: ice, rest, prednisone, methylprednisolone (medrol), anti -inflammatory and paracetamol for excruciating pain/chronic pain of left knee; ice, rest, prednisone, methylprednisolone (medrol) and anti -inflammatory for swelling; ice, rest, wheel chair and anti -inflammatory for hurts to walk, levofloxacin for join infection; not reported for other events outcome: recovered for redness, recovering for neuropathic pain and unknown for other 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: required intervention for device malfunction, excruciating pain, swelling/left knee was double its normal size; disability for hurts to walk/could not walk, medically significant for joint infection additional information was received on 28-may-2018 from a health care professional.The case was medically confirmed.The case was upgraded to serious.Patient's age, weight and height were added.Medical history and concomitant medications were added.Treatment start and stop date, dose, frequency, indication and lot number was added.Action taken was updated from unknown to not applicable.The event of personal injury was deleted.Additional events of excruciating pain, swelling/ l knee was double its normal size, hurts to walk/could not walk, left knee effusion, sciatica had flared, congestion, cough, sleep has been greatly affected, itching eyes, redness in left knee, rom is limited due to the pain, joint infection, knee was slightly warm, neuropathy type pain, ecg was abnormal, alkaline phosphatase high, bilirubin total low and eosinophil percentage high and device malfunction were added along with details.Clinical course was updated and text was amended accordingly.
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Event Description
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Device malfunction [device malfunction].L total knee replacement [total knee replacement].Acute kidney injury [acute kidney injury].Hurts to walk/could not walk/ gait alterations/ difficulty walking/gait abnormality [difficulty in walking].Joint infection [joint infection].Swelling/left knee was double its normal size [knee swelling] ([condition aggravated]).Excrutiating pain/pain is worsened with activity/ acute pain in left knee/ l knee pain/ medial lateral tenderness [knee pain] ([condition aggravated]).Congestion [congestion pulmonary].Redness in left knee/ redness/ l calf was red [redness].Itching in eyes [itching eyes].Cough [cough].Sleep has been greatly affected [sleep disorder].Sciatica had flared [sciatica aggravated].Rom is limited due to the pain/ tightness with l knee flexion/ difficulty bending her knee [joint range of motion decreased].T wave abnormality [electrocardiogram t wave abnormal].Neuropathy type pain [neuropathic pain].Eosinophil percentage high [eosinophil percentage increased].Bilirubin total low [bilirubin total low].Alkaline phosphatase high [alkaline phosphatase increased].Spasms [spasms].Limited weightbearing [weight bearing difficulty].Acute postoperative pain/surgical pain/7/10 [postoperative pain].Colour change [skin discolouration].Generalized swelling [edema generalized].Limited muscular endurance [muscular weakness].L knee discomfort/ complaint with her hep/l knee irritability [discomfort in joints].([condition aggravated]).Neck pain [neck pain].Back pain/low back has been irritated [back pain].Agitation [agitation].Confusion [confusion].Decreased concentration [concentration impaired].Numbness in her lower calf [numbness in leg].Cardiac symptoms included pain [chest pain].Swelling of limb/left leg swelling from ankle to thigh [swelling of limb].Nausea [nausea].Limited strength/weakness [strength loss of].Edema [oedema knees].Fatigue [fatigue].Knee was mildly warm/ warmth [joint warmth].Stiff [stiff knees].Left knee effusion [knee effusion].Case narrative: based on additional information received on 04-jun-2018 from a health care professional (hcp), the case was medically confirmed.Also this case initially considered as non-serious was upgraded to serious as the serious events of device malfunction, excruciating pain, swlg/left knee was double its normal size (seriousness criteria: required intervention), hurts to walk/could not walk (seriousness criteria: disability) and joint infection (seriousness criteria: medically significant) were added.Initial information received on 12-feb-2018 regarding an unsolicited valid serious case from united states received from a lawyer.This case involves a 58 years old female patient (pt) who was treated with hylan g-f 20, sodium hyaluronate (synvisc one) injection and on the same day had excruciating pain, swlg/ l knee was double its normal size and hurts to walk/could not walk/ gait alterations/ diffiliculty walking/gait abnormality, after 1 day had spasms and after 2 days had left knee effusion (efsn) and after unknown latency sciatica had flared, congestion, cough, sleep has been greatly affected and itching eyes, after few days redness in left knee/ redness/ l calf was red, rom is limited due to the pain/ tightness with l knee flexion/ difficulty bending her knee, joint infection, knee was mildly warm/ warmth, had limited weightbearing and neuropathy type pain, after 1 month and 28 days ecg was abnormal, after 2 months and 06 days alkaline phosphatase high, bilirubin total low and eosinophil percentage high, after 6 months and 3 days had acute kidney injury, acute postoperative pain/surgical pain/7/10, after 6 months 7 days had color change.After unknown latency had edema, generalized swlg, limited muscular endurance, l knee discomfort/ complaint with her hep/l knee irritability, neck pain, back pain/low back has been irritated, agitation, confusion, decreased concentration, numbness in her lower calf, swelling (swlg) of limb/left leg swlg from ankle to thigh, nausea, cardiac symptoms included pain, limited strength/weakness, fatigue and stiff.Also device malfunction was reported for this lot number.Pt's medical history included acute constipation, lower mid abdominal pain, sciatica, arrhythmias, primary osteoarthritis of left knee, hallux rigidus of both feet, back pain, gait problem, neck pain, neck stiffness, acute medial meniscus tear, left, locking, catching, snapping, crepitus in left knee, anxiety (unspecified), decreased concentration, bipolar disorder (in partial remission, most recent episode depressed: since on (b)(6) 2017), asthma (childhood after having pneumonia resolved after t/t), colitis unspecified (hospitalized on (b)(6) 2013), diverticulitis (hospitalized jul-2013), pneumonia, hypothyroid, unspecified, osteoarthritis, rheumatoid arthritis, cholecystectomy, cystourethroscopy on (b)(6) 2014), excision morton's neuroma on (b)(6) 2015), partial joint replacement (rplcmt) (sep-2008), knee arthroscopy (1976), laparoscopic cholecystectomy, laparoscopic colectomy partial w/anastamosis on (b)(6) 2014).Other surgical history included tendonitis, 10% disability in wrists in 1980's, left shoulder-bursa removal also clavical (oct-2007), right knee arthroscopy (1977), right knee surgery (partial knee rplcmt in 2008), right shoulder rotator cuff and clavicle repairs, tarsal tunnel in the right foot two repairs, transfer adjacent tissue hand (on (b)(6) 2016).Concurrent conditions included panic disorder with agoraphobia and panic attacks in partial remission, depression, hypertriglyceridemia, gastroesophageal reflux disease, chronic pain in left foot (since on (b)(6) 2013), neuroma, morton's (since on (b)(6) 2013), morton's neuroma of third interspaces of both feet (since on (b)(6) 2017), other specified dermatosis (since on (b)(6)2015), right finger pain (since on (b)(6) 2016), finger stiffness right (since on (b)(6) 2017), acute medial meniscus tear, left, initial encounter, post right partial knee rplcmt (on (b)(6) 2017), excision morton's neuroma, left rotator cuff repair and other surgery for tendonitis, 10% disability in wrists.Pt was allergic to epinephrine hydrochloride (epinephrine) (shortness of breath) and oxycodone (itching).Pt was positive for environmental allergies and food allergies.Pt was never a smoker and did not use alcohol.Family history included breast cancer (maternal grandmother), cancer, depression, hypertension, stroke and osteoarthritis (mother), dementia, hypertension and stroke (father), diabetes type ii, hypertension, hyperlipidemia and stroke in sister.Past drug included tdap (on (b)(6) 2015) and varicella (varivax) (on (b)(6) 2012).Concomitant medications included paracetamol (tylenol), acetylsalicylic acid (aspirin ec), buspirone hydrochloride (buspar), clonazepam (klonopin), diphenhydramine hydrochloride (benadryl), esomeprazole sodium (nexium), chondroitin sulfate sodium, glucosamine hydrochloride (glucosamine/chondroitin (chondroitin sulfate sodium;glucosamine hydrochloride)), lithium, lorazepam, ascorbic acid, betacarotene, copper, glycine max extract, herbal oil nos, oryza sativa oil, vaccinium myrtillus, vitamin e nos, xantofyl, zeaxanthin, zinc (lutein complex), gemfibrozil (lopid), levothyroxine sodium (synthroid), potassium chloride, gabapentin (neurontin), hydromorphone hydrochloride (dilaudid), docusate sodium, senna alexandrina (senokot-s), macrogol 3350 (miralax), meloxicam (mobic) and ropivacaine.On (b)(6) 2017, at 15:49, the pt received treatment (t/t) with intra-articular hylan g-f 20, sodium hyaluronate injection from anterolateral portal using 20 gauge needle, at a dose: 16 mg, once (lot number: 7rsl021 and expiry date: not provided) in left knee for primary osteoarthritis of left knee and chronic pain of left knee after betadine/cold spray.On the same day, by 09:00 pm her left knee was double its normal size with excruciating pain worse than her baseline and pt's pain on pain score was 6.Pain was so severe that she could not walk.On (b)(6) 2017, pt had pain, swlg and it hurts to walk.On (b)(6) 2017, pt's musculoskeletal knee examination showed efsn in left knee without redness.Pt was on wheel chair.Pt was advised that this was an adverse reaction to synvisc one.Pt should not have any further injections.Pt should continue ice and limited weight bearing until the pain resolved.This level of pain lasted almost two weeks, then lessened slightly probably as pt was given an oral dose of prednisolone to help with the pain and swlg.Pt's pain score on the same day was 10.As of on (b)(6) 2017, pt had complaints of continued pain, swlg, difficulty walking and redness.The pt had received the contaminated synvisc-one.On (b)(6) 2018, pt had left knee x-ray and was diagnosed with chronic pain of left knee, tricompartmental degenerative arthritis with mild narrowing of the medial compartment and tricompartmental osteophytosis.Diffuse demineralization was noticed.There was significant arthritis in knee.There was bone on bone joint space narrowing and early osteophyte formation.On the same day, pt's c-reactive protein was 0.13 mg/dl (reference range: 0.60 mg/dl).Pt's pain on pain scale was 6 on same day.On the same day, pt's left knee musculoskeletal examination showed flexion: 80, extension: 10 and efsn 1+.The pt needed assistance for ambulation and was at high risk for falls.On an unknown date, after unknown latency, pt had congestion, cough and itching eyes.On (b)(6) 2018, pt's pain on pain scale was 7/10 on same day and was sharp.As of on (b)(6) 2018, the pain had plateaued but at a level much higher than her previous baseline and had persisted to this day.Pt's left knee was very mildly effused medially, otherwise unremarkable appearance; mild tenderness to palpation medially and superior to patella; no excessive warmth.Intact passive rom, but pain inhibition noted during active rom.No lower extremity edema.Pt's sleep had been greatly affected, and her sciatica had flared as a result (onset date and latency: unknown).Pain was worsened with activity.On an unknown date, few days after the injection, range of motion (rom) is limited due to the pain.No fevers/chills/night seats (but was still going through menopause).Pt was not taking any pain medications (could not take non-steroidal anti-inflammatory disease due to liver issues, and paracetamol (tylenol) did not help at all).It was reported that pt was now with persistent worsened left knee pain following possibly contaminated (with methylobacterium thiocyanatum) synvisc one injection to her left knee.On the same day, aspiration was requested with samples sent for culture and cytology, but there was no fluid in the knee on aspiration attempt.Since the orthopedician could not completely exclude infection (joint infection) (onset date: unknown) in this case, pt would start course of oral levofloxacin (levaquin) 750mg bid for 14 days.On (b)(6) 2018, pt had electrocardiogram (ecg) and the result was abnormal.Nonspecific t wave abnormalities, anterolateral leads were now present.When compared with ecg of on (b)(6) 2014, sinus rhythm had replaced sinus bradycardia.On an unknown date, pt had neuropathy type pain.As of on (b)(6) 2018, pt was not interested in pursuing anything more with her neuropathy type pain.Pt's pain score was 7 on the same day.On (b)(6) 2018, pt presented for aspiration of left knee for possible infection and fluid would be sent for cultures.Under sterile conditions, knee was attempted to be aspirated with ultrasound guidance but no fluid was able to be aspirated.Needle was withdrawn and site was cleaned and dressed.Pt's physical exam on the same day showed that the left knee was without redness.Knee was mildly warm with trace efsn.Patellar mobility normal.Unable to flex knee past 60 degrees due to discomfort but was keeping the knee straight.On the same day, ultrasound did not showed any collectible area of fluid but did show thickened synovium.Pt's pain was 8 on pain score.On (b)(6) 2018, pt's eosinophil% was: 9.5% (h) (normal range: 0-7.0), bilirubin total: 0.3 mg/dl (l) (normal range: 24-110), alkaline phosphatase: 122 u/l (h) (normal range: 3.5-4.8).On (b)(6) 2018, pt had gait abnormality.On (b)(6) 2018, pt had l total knee rplcmt for which pt was hospitalized from on (b)(6) 2018.Her wounds had been healing without problems.From the same day, she had primary impairments including difficulty walking, limited strength, limited range of motion, limited flexibility, limited muscular endurance, limited cardiopulmonary endurance, impaired gait and pain.On (b)(6) 2019, at 12:17 hours, left knee acute surgical pain was noted to be 7 on scale of 10, was intermittent, and felt with activity.Pain was managed with cold, applied, repositioned, rest.Pt was satisfied with pain management.The same day at 15:53 hours, pain scale was noted to be 8/10, with knee discomfort, short acting opioid was given.The same day, pt had acute kidney injury (aki).On (b)(6) 2018, pt woke up with diffuse l leg swlg from ankle to thigh (swollen over night); also had redness and warmth which prompted her to go to hospital but denied fever and chills.She has not had systemic symptoms.Nerve block remained in place.Pt was at high risk for falls.Patient was hospitalized on same day.She also complained of associated leg pain, redness and that leg was warm to the touch and rated pain 9/10 in severity and also endorsed nausea, though it had resolved at bedside.She also stated that she had been elevating leg while sleeping at night, using the compression socks and icing regularly.The same day, pt's cardiac symptoms included pain.Redness and swlg had improved than morning.Differential diagnosis included but post-operative pain vs infection vs dvt.On (b)(6) 2018, it was observed that hemoglobin was 141 mg/dl (high), c-reactive protein was 5.00 mg/dl (high), hematocrit was 32.1 % (low), hemoglobin was 10.6 g/dl (low), red blood cell count was 3.56x10e12/l (low), elevated esr, glucose 141 (high), no leukocytosis, x-ray showed edema, mild efsn and small amount of air likely post-operative.At time of sign out, pt had received dilaudid and tylenol.Same day at 04:39, orthopedic signed off on discharge, stated that there was no infection present and this was normal post-operative pain and swlg.Also, dvt was ruled out and patient was discharged.On (b)(6) 2018, during the visit, it was observed that pt had weakness, moderate l knee pain and edema.She reported tightness with l knee flexion and difficulty walking.Patient was using a rolling walker as he had left antalgic gait.On (b)(6) 2018, on telephonic follow up, denied any numbness, tingling, or weakness in the affected extremity, site was non-tender.On (b)(6) 2018, during evaluation pt stated that her symptoms had been improved.It was also reported that her nerve block was removed and had been having increased l knee pain since then which was 8/10 on scale, aching, burning, constant, gradually worsening.On (b)(6) 2018, patient informed that pain was worse since last night and asked to renew the prescription for hydromorphone.On (b)(6) 2018, it was reported that pt had moderate l knee soreness and pain present (constant, aching, burning, throbbing, pressure, sore).During the medical evaluation of on (b)(6) 2018, it was observed that pt had leg swlg, fatigue, agitation, confusion, decreased concentration, gait problem and neck pain.On (b)(6) 2018, pt was medically examined, and it was observed that pt was able to achieve 94-degree l knee arom flex within t/t.L quad strength with functioning stepping remained limited.During the examination of on (b)(6) 2018, it was observed that her symptoms were improved.On the visit on (b)(6) 2018, pt was observed with moderate left knee stiffness but able to improve l knee arom flex to 98 degree.During the medical examination on (b)(6) 2018, pt was observed with back pain.Pt visited the healthcare facility on (b)(6) 2018 and she had been having difficulty in descending stairs through her left knee and had clicking present, otherwise she reported that she had complaint with her hep.She reported scar taping had been helping.In her next weekly visit to the hospital i.E.On (b)(6) 2018, she stated that she felt a tight band across her knee and still had difficulty bending her knee.She reported she had less lateral l knee pain since her last visit and it was also reported she was happy with her scar.She also reported about moderate stiffness with l knee arom flex with hep updated to focus on rom with increasing to 2x/day to perform with assistance of her husband.On (b)(6) 2018, it was observed that pt had increased l knee swlg and limited rom due to increased activity level over the last several days.During the visit on (b)(6) 2018, pt reported that she decreased her activity level and her l knee had less pain/ swlg present.It was also reported that she had been using her tens at home.On (b)(6) 2018, pt presented with l knee swlg and irritability.However, she continued to have nave moderate l knee stiffness present.On (b)(6) 2018, pt underwent lab analysis and it was observed that bilirubin conjugated was 0.1 mg/dl (low), alkaline phosphatase was 132 u/l (high), total bilirubin was 0.8 mg/dl (normal), hematocrit was 37.5 % (normal), hemoglobin was 12.6 g/dl (normal) and red blood cell count was 4.52x 10e12/l (normal).Corrective t/t: cold, applied, repositioned, rest, short acting opioid for acute postoperative pain/surgical pain/7/10; ice, rest, prednisone, methylprednisolone (medrol), anti -inflammatory and paracetamol for excruciating pain/chronic pain of left knee; ice, rest, prednisone, methylprednisolone (medrol) and anti -inflammatory for swlg; ice, rest, wheel chair and anti -inflammatory for hurts to walk/could not walk/ gait alterations/ difficulty walking/gait abnormality, levofloxacin for joint infection; dilaudid and tylenol for left knee effusion, redness in left knee/ redness/ l calf was red and swelling of limb/left leg swelling from ankle to thigh; not reported for other events.Outcome: recovered for color change, nausea; recovering for excruciating pain/pain is worsened with activity/ acute pain in left knee/ l knee pain/ medial lateral tenderness, redness in left knee/ redness/ l calf was red, neuropathy type pain, hurts to walk/could not walk/ gait alterations/ difficulty walking/gait abnormality, edema, limited weightbearing, knee was mildly warm/ warmth, rom is limited due to the pain/ tightness with l knee flexion/ difficulty bending her knee; not recovered for swlg/left knee was double its normal size, stiff and left knee efsn; unknown for rest all 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: required intervention for device malfunction, l total knee rplcmt, excruciating pain, swlg/left knee was double its normal size; disability for hurts to walk/could not walk/ gait alterations/ difficulty walking, medically significant for joint infection, acute kidney injury and pulmonary congestion; hospitalization for l total knee rplcmt.Additional information was received on 28-may-2018 from a hcp.The case was medically confirmed; upgraded to serious.Pt's demographics added.Medical history and concomitant medications added.Suspect regimen and lot number was added.Action taken was updated.The event of personal injury was deleted.Additional events of excruciating pain, swlg/ l knee was double its normal size, hurts to walk/could not walk, left knee efsn, sciatica had flared, congestion, cough, sleep has been greatly affected, itching eyes, redness in left knee, rom is limited due to the pain, joint infection, knee was slightly warm, neuropathy type pain, ecg was abnormal, alkaline phosphatase high, bilirubin total low and eosinophil percentage high and device malfunction were added.Upon internal review on 27-nov-2018, the reporter causality was updated from not reported to related.Additional information was received on 15-may-2019 from the lawyer.Medical history added.Additional events of acute postoperative pain/surgical pain/7/10, colour change, edema, generalized swlg, limited muscular endurance, l knee discomfort/ complaint with her hep/l knee irritability, neck pain, back pain/low back has been irritated, agitation, confusion, decreased concentration, numbness in her lower calf, swlg of limb/ leg swlg, nausea, limited strength/weakness, fatigue and stiff were added.Verbatim updated to hurts to walk/could not walk/ gait alterations/ difficulty walking/gait abnormality.Verbatim updated to redness in left knee/ redness/ l calf was red.Concomitant medication added.
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Event Description
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Device malfunction [device malfunction] ; hurts to walk/could not walk [difficulty in walking] ; joint infection [joint infection] ; swelling/left knee was double its normal size [knee swelling]; excruciating pain/pain is worsened with activity [knee pain] ; congestion [congestion pulmonary] ; redness in left knee [redness] ; itching in eyes [itching eyes]; cough [cough] ; sleep has been greatly affected [sleep difficult]; sciatica had flared [sciatica aggravated]; rom is limited due to the pain [joint range of motion decreased]; t wave abnormality [electrocardiogram t wave abnormal]; neuropathy type pain [neuropathic pain] ; knee was mildly warm [joint warmth]; eosinophil percentage high [eosinophil percentage increased] ; bilirubin total low [bilirubin total low] ; alkaline phosphatase high [alkaline phosphatase increased] ; spasms [spasms]; limited weightbearing [weight bearing difficulty] ; left knee effusion [knee effusion].Case narrative: based on additional information received on 04-jun-2018 from a health care professional, the case was medically confirmed.Also this case initially considered as non-serious was upgraded to serious as the serious events of device malfunction, excruciating pain, swelling/left knee was double its normal size (seriousness criteria: required intervention), hurts to walk/could not walk (seriousness criteria: disability) and joint infection (seriousness criteria: medically significant) were added.Initial information received on 12-feb-2018 regarding an unsolicited valid serious case from united states received from a lawyer.This case involves a 58 years old female patient who was treated with hylan g-f 20, sodium hyaluronate (synvisc one) injection and on the same day had excruciating pain, swelling/ l knee was double its normal size and hurts to walk/could not walk, after 1 day had spasms and after 2 days had left knee effusion and after unknown latency sciatica had flared, congestion, cough, sleep has been greatly affected and itching eyes, after few days had redness in left knee, rom is limited due to the pain, joint infection, knee was slightly warm, had limited weightbearing and neuropathy type pain, after 1 month and 28 days ecg was abnormal, after 2 months and 06 days alkaline phosphatase high, bilirubin total low and eosinophil percentage high.Also device malfunction was reported for this lot number.Patient's medical history included acute constipation, lower mid abdominal pain, sciatica, arrhythmias, primary osteoarthritis of left knee, hallux rigidus of both feet, back pain, gait problem, neck pain, neck stiffness, acute medial meniscus tear, left, locking, catching, snapping, crepitus in left knee, anxiety (unspecified), decreased concentration, bipolar disorder (in partial remission, most recent episode depressed: since (b)(6) 2017), asthma (childhood after having pneumonia resolved after treatment), colitis unspecified (hospitalized on (b)(6) 2013), diverticulitis (hospitalized (b)(6) 2013), pneumonia, hypothyroid, unspecified, osteoarthritis, rheumatoid arthritis, cholecystectomy, cystourethroscopy ((b)(6) 2014), excision morton's neuroma ((b)(6) 2015), partial joint replacement ((b)(6) 2008), knee arthroscopy (1976), laparoscopic cholecystectomy, laparoscopic colectomy partial w/anastamosis ((b)(6) 2014).Other surgical history included tendonitis, 10% disability in wrists in 1980's, left shoulder-bursa removal also clavicle ((b)(6) 2007), right knee arthroscopy (1977), right knee surgery (partial knee replacement in 2008), right shoulder rotator cuff and clavicle repairs, tarsal tunnel in the right foot two repairs, transfer adjacent tissue hand (on (b)(6) 2016).Concurrent conditions included panic disorder with agoraphobia and panic attacks in partial remission, depression, hypertriglyceridemia, gastroesophageal reflux disease, chronic pain in left foot (since (b)(6) 2013), neuroma, morton's (since (b)(6) 2013), morton's neuroma of third interspaces of both feet (since (b)(6) 2017), other specified dermatosis (since (b)(6) 2015), right finger pain (since(b)(6) 2016), finger stiffness right (since (b)(6) 2017), acute medial meniscus tear, left, initial encounter, post right partial knee replacement ((b)(6) 2017).Patient was allergic to epinephrine hydrochloride (epinephrine) (shortness of breath) and oxycodone (itching).Patient was positive for environmental allergies and food allergies.Patient was never a smoker and did not use alcohol.Family history included breast cancer (maternal grandmother), cancer, depression, hypertension and stroke (mother), dementia, hypertension and stroke (father), diabetes type ii, hypertension and hyperlipidemia in sister.Past drug included tdap ((b)(6) 2015) and varicella (varivax) ((b)(6) 2012).Concomitant medications included paracetamol (tylenol), acetylsalicylic acid (aspirin ec), buspirone hydrochloride (buspar), clonazepam (klonopin), diphenhydramine hydrochloride (benadryl), esomeprazole sodium (nexium), chondroitin sulfate sodium, glucosamine hydrochloride (glucosamine/chondroitin (chondroitin sulfate sodium;glucosamine hydrochloride)), lithium, lorazepam, ascorbic acid, betacarotene, copper, glycine max extract, herbal oil nos, oryza sativa oil, vaccinium myrtillus, vitamin e nos, xantofyl, zeaxanthin, zinc (lutein complex), gemfibrozil (lopid), levothyroxine sodium (synthroid), potassium chloride, gabapentin (neurontin).On (b)(6) 2017, at 15:49, the patient received treatment with intra-articular hylan g-f 20, sodium hyaluronate injection from anterolateral portal using 20 gauge needle, at a dose: 16 mg, once (lot number: 7rsl021 and expiry date: not provided) in left knee for primary osteoarthritis of left knee and chronic pain of left knee after betadine/cold spray.On the same day, by 09:00 pm her left knee was double its normal size with excruciating pain worse than her baseline and patient's pain on pain score was 6.Pain was so severe that she could not walk.On (b)(6) 2017, patient had pain, swelling and it hurts to walk.On (b)(6) 2017, patient's musculoskeletal knee examination showed effusion in left knee without redness.Patient was on wheel chair.Patient was advised that this was an adverse reaction to synvisc one.Patient should not have any further injections.Patient should continue ice and limited weight bearing until the pain resolved.This level of pain lasted almost two weeks, then lessened slightly probably as patient was given an oral dose of prednisolone to help with the pain and swelling.Patient's pain score on the same day was 10.As of (b)(6) 2017, patient had complaints of continued pain, swelling, difficulty walking and redness.It was reported that the patient had received the contaminated synvisc-one.On (b)(6) 2018, patient had left knee x-ray and was diagnosed with chronic pain of left knee, tricompartmental degenerative arthritis with mild narrowing of the medial compartment and tricompartmental osteophytosis.Diffuse demineralization was noticed.There was significant arthritis in knee.There was bone on bone joint space narrowing and early osteophyte formation.On the same day, patient's c-reactive protein was 0.13 mg/dl (reference range: <=0.60 mg/dl).Patient's pain on pain scale was 6 on same day.On the same day, patient's left knee musculoskeletal examination showed flexion: 80, extension: 10 and effusion 1+.It was reported that the patient needed assistance for ambulation and was at high risk for falls.On an unknown date, after unknown latency, patient had congestion, cough and itching eyes.On (b)(6) 2018, patient's pain on pain scale was 7/10 on same day and was sharp.As of (b)(6) 2018, the pain had plateaued but at a level much higher than her previous baseline and had persisted to this day.Patient's left knee was very mildly effused medially, otherwise unremarkable appearance; mild tenderness to palpation medially and superior to patella; no excessive warmth.Intact passive rom, but pain inhibition noted during active rom.No lower extremity edema.It was reported that patient's sleep had been greatly affected, and her sciatica had flared as a result (onset date and latency: unknown).Pain was worsened with activity.On an unknown date, few days after the injection, range of motion (rom) is limited due to the pain.No fevers/chills/night seats (but was still going through menopause).Patient was not taking any pain medications (could not take non-steroidal anti-inflammatory disease due to liver issues, and paracetamol (tylenol) did not help at all).It was reported that patient was now with persistent worsened left knee pain following possibly contaminated (with methylobacterium thiocyanatum) synvisc one injection to her left knee.On the same day, aspiration was requested with samples sent for culture and cytology, but there was no fluid in the knee on aspiration attempt.Since the orthopedician could not completely exclude infection (joint infection) (onset date: unknown) in this case, patient would start course of oral levofloxacin (levaquin) 750mg bid for 14 days.On (b)(6) 2018, patient had electrocardiogram (ecg) and the result was abnormal.Nonspecific t wave abnormalities, anterolateral leads were now present.When compared with ecg of(b)(6) 2014, sinus rhythm had replaced sinus bradycardia.On an unknown date, after unknown latency, patient had neuropathy type pain.As of (b)(6) 2018, patient was not interested in pursuing anything more with her neuropathy type pain.Patient's pain score was 7 on the same day.On (b)(6) 2018, patient presented for aspiration of left knee for possible infection and fluid would be sent for cultures.Under sterile conditions, knee was attempted to be aspirated with ultrasound guidance but no fluid was able to be aspirated.Needle was withdrawn and site was cleaned and dressed.Patient's physical exam on the same day showed that the left knee was without redness.Knee was mildly warm with trace effusion.Patellar mobility normal.Unable to flex knee past 60 degrees due to discomfort but was keeping the knee straight.On the same day, ultrasound did not showed any collectible area of fluid but did show thickened synovium.Patient's pain was 8 on pain score.On (b)(6) 2018, patient's eosinophil% was: 9.5% (h) (normal range: 0-7.0), bilirubin total: 0.3 mg/dl (l) (normal range: 24-110), alkaline phosphatase: 122 u/l (h) (normal range: 3.5-4.8), corrective treatment: ice, rest, prednisone, methylprednisolone (medrol), anti -inflammatory and paracetamol for excruciating pain/chronic pain of left knee; ice, rest, prednisone, methylprednisolone (medrol) and anti -inflammatory for swelling; ice, rest, wheel chair and anti -inflammatory for hurts to walk, levofloxacin for join infection; not reported for other events.Outcome: recovered for redness, recovering for neuropathic pain and unknown for other 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 (b)(6) 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: required intervention for device malfunction, excruciating pain, swelling/left knee was double its normal size; disability for hurts to walk/could not walk, medically significant for joint infection and pulmonary congestion.Additional information was received on 28-may-2018 from a health care professional.The case was medically confirmed.The case was upgraded to serious.Patient's age, weight and height were added.Medical history and concomitant medications were added.Treatment start and stop date, dose, frequency, indication and lot number was added.Action taken was updated from unknown to not applicable.The event of personal injury was deleted.Additional events of excruciating pain, swelling/ l knee was double its normal size, hurts to walk/could not walk, left knee effusion, sciatica had flared, congestion, cough, sleep has been greatly affected, itching eyes, redness in left knee, rom is limited due to the pain, joint infection, knee was slightly warm, neuropathy type pain, ecg was abnormal, alkaline phosphatase high, bilirubin total low and eosinophil percentage high and device malfunction were added along with details.Clinical course was updated and text was amended accordingly.Upon internal review on 27-nov-2018, the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.
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