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Left knee degenerative joint disease [degenerative joint disease] ([difficulty in standing], [joint crepitation]); device malfunction [device malfunction] ; inflammatory reaction [joint inflammation] ([joint effusion], [synovial fluid polymorphonuclear leukocyte positive], [joint clicking], [knee pain], [swelling of l knee], [synovial fluid analysis abnormal], [joint warmth], [joint range of motion decreased]).Case narrative: based on additional information received on 27-aug-2018, reporter causality was updated from unassessable to related.Based on additional information received on 04-jun-2018 from physician, the case became medically confirmed.This case is cross referred with the case (b)(4) (duplicate).This spontaneous legal case from united states was received on 29-dec-2017 from patient's wife.This case concerns a 44 years old caucasian/ white male patient who initiated treatment with synvisc one and after unknown latency had inflammatory reaction, left knee degenerative joint disease.Patient was a former smoker (cigarettes: 0.50 packs/ day for 11 years till (b)(6) 2003), alcohol user.Allergy history included penicillin allergy (reaction: hives).Medical history included anemia, anxiety, asthma, blood transfusion, cancer, cataract, congestive heart failure, clotting disorder, chronic obstructive pulmonary disease (copd), depression, emphysema, gastroesophageal reflux disease, glaucoma, heart murmur, hiv infection, kidney disease, meningitis, myocardial infarction, neuromuscular disorder, osteoporosis, seizures, sickle cell anemia, stroke, substance abuse, tuberculosis, ulcer, thyroid disease, blood pressure, eustachian tube dysfunction and low back pain since 2007, pharyngitis, lymphadenopathy, cough, fever, chills, influenza and pain since 2008, diabetic foot, left foot pain, diabetic polyneuropathy associated with type 2 diabetes mellitus and primary osteoarthritis of right foot diagnosed on (b)(6) 2017, grade 4 chondromalacia of the medial and patellofemoral compartments in knee.Circumcision on (b)(6) 1973, diarrhea and vomiting ((b)(6) 1975), acute gastroenteritis, viral type ((b)(4) 1975), laceration forehead ((b)(6) 1978), fracture small chip from proximal articular surface on the palmar side of the proximal phalanx of the left index finger ((b)(6) 1988), laceration ((b)(6) 1997), large ganglion cyst on forefoot ((b)(6) 1999), sebaceous cyst, likely viral upper respiratory infection and laryngitis (b)(6) 2000), probable labyrinthitis ((b)(6) 2000), lateral epicondylitis of the left ((b)(6) 2001), acute rhinitis ((b)(6) 2001), sinusitis ((b)(6) 2005), arrhythmias with some symptoms ((b)(6) 2005), atypical chest pain ((b)(4) 2005), gout (took indomethacin), flu vaccinations (flu vaccine trivalent single dose on (b)(6) 2012; flu vaccine single dose on (b)(6) 2015; flu vaccine trivalent single dose on (b)(6) 2013).Past drugs included ibuprofen (advil), blood glucose test, natural products (osteo-bi-flex joint shield), prevident 5000 sensitive and omega 3 fatty acids (fish oil).Surgical history included initial inguinal hernia reducible surgery at the age of 5 (had hernia repair right on (b)(6) 1973 and left inguinal herniorrhaphy on (b)(6) 1975), right foot surgery in 2000, vasectomy in 2008, right foot bunionectomy on (b)(6) 2015, left knee arthroscopy on (b)(6) 2016 (left knee arthroscopy with a partial medial meniscetomy, patella femoral chondroplasty leading to decreased range of motion, decreased strength, pain and swelling in knee), acute pain of left knee (since (b)(6) 2016).Family history included heart and prostate cancer (father), diabetes (mother), high cholesterol (parents) and meningitis (brother).Concomitant medications included indomethacin (indocin), sitagliptin phosphate (januvia), metformin hydrochloride (glucophage), fluticasone propionate (flonase), lisinopril dihydrate hydrochlorothiazide (prinzide), nicotinic acid (niaspan), ezetimibe (zetia), canagliflozin (invokana), indometacin (indocine), fish oil, chondroitin sulfate, glucosamine hydrochloride (osteo bi-flex), and sodium fluoride (prevident 5000 sensitive).Patient had received cortisone injection on (b)(6) 2017 that helped but started to wear off.Concurrent conditions included diabetes mellitus type 2, palpitations (since (b)(6) 2007), hyperlipidemia (since (b)(6) 2007), hypertension (since (b)(6) 2007) and inguinal hernia.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (batch number: 7rsl021; expiry date: 31-may-2020) for bone to bone, left knee pain and primary osteoarthritis of left knee.The patient tolerated the procedure well without complications.Sterile dressing was applied.On the same day, patient had left knee swelling after the injection and left knee pain was 3 on pain scale.Pain was described as dull, throbbing aches that was aggravated on sitting and walking.The pain was at the top and bottom of the knee.Patient compared it to the sensation of muscle cramp.Patient also could not bend or straighten the knee without pain on the same day.Nurse advised patient to ice, elevate and use over the counter non steroidal anti-inflammatory drugs (otc nsaids).Reporter stated that he received the injection at 3 pm on monday and by 6 pm tuesday, on (b)(6) 2017, he couldn't even bend his knee and he missed a day of work.On (b)(6) 2017, patient denied redness or drainage to injection site.Patient just had swelling and pain to the knee.It was reported that the knee swelled up to the size of a cantalope.Physician's assistant made sure that there was no sign of infection as of (b)(6) 2017.On (b)(6) 2017, the product recall was issued.It was reported that the patient had received the synvisc one injection from the contaminated lot.On (b)(6) 2017 he had lab work done that they are being billed for but no he has had no treatment.The synovial fluid aspirate showed 4316/mcl nucleated cells (0-200/mcl; high), with 49 % polymorphonucleated cells (pmns) (0-25%; high).Wbc count, c-reactive protein and erythrocyte sedimentation rate (esr) were normal and culture did not show any growth.It was felt that his persistent symptoms warrant total knee arthroplasty.As of (b)(6) 2017, patient's knee was still swollen.He physically felt better but still had pain (on a pain scale he was at a 8 or 9 every day and when he came home he can't do anything at all) (onset: (b)(6) 2017).Patient could not fully straighten the knee or bend past 90 degrees.Patient denies redness but noted some warmth to the knee.Patient's swelling was to the lateral knee and swelling was as big as a cantaloupe at times but on (b)(6) 2017, it was about the size of a lemon.Patient would like to proceed with a knee replacement if that was the next step.Patient used anti-inflammatory medicines.A medial unloader brace was also somewhat helpful.On (b)(6) 2017 at 16:25 hours, the patient again had lab work done including blood test which revealed platelet count: 554 k/ul (140-400 k/ul; high).On (b)(6) 2018, the left knee examination revealed mild effusion, radiographic examination showed left knee medial compartment and patella femoral department osteoarthritis.Patient reported that the swelling improved but continued to have pain 4/10 and described it as achy in nature.Patient rated pain as 2/10 at rest and 5/10 at bending.Patient has some popping and feelings of knee wanting to hyperextend on him.Patient was utilizing the medial unloader brace and stated that he cannot increase the brace anymore as he maxed out.Patient had pain with prolonged standing or weight bearing activities, so he used ibuprofen and heat on an as -needed basis.Labs confirmed inflammatory reaction without any obvious infection.As of (b)(6) 2018, patient's pain was at 4/10 treated with ibuprofen and heat.Patient also heard popping when walking.Pain aggravated on bending, movement and walking.As of (b)(6) 2018, it was reported that the patient rises from a chair with mild difficulty.Gait was antalgic favoring the left.There was varus alignment of the left knee.Left hip motion was full and painless.Left knee motion was -3-120 degree.There was tenderness along the medial joint line and medial pseudo-laxity.There was crepitus with left knee motion.There was good strength with knee extension against resistance.There was moderately severe patellofemoral degenerative change as compared to previous x-rays.Patient was thus diagnosed with severe left knee degenerative joint disease.He had significant 2 compartment involvement and total knee arthroplasty is the appropriate consideration.On (b)(6) 2018, patient's hemoglobin a1c was 6.5% (h) (range: 4.3-5.6%).On (b)(6) 2018, patient was recommended to proceed with another esr and crp due to the increasing pain to verify that there was no infection causing this pain.The next step would be to repeat a cortisone injection in the knee to alleviate his pain.But the patient wanted to try something else for pain in knee so that he could make it to june for knee surgery.Patient was then recommended to maximize the conservative options including tylenol, ibuprofen (if able to take these), ice, heat, use of a cane/walker as needed, and activity modification.On (b)(6) 2018, patient's esr: 7 mm/hr (range: 0-22) and crp: <5.0 mg/l (range: 0.0-9.9).On (b)(6) 2018, patient had left total knee arthroplasty.Corrective treatment: ice, ibuprofen, meloxicam (mobic), elevate, otc nsaid's ketorolac tromethamine (toradol), hydrocodone for still in pain/ on a pain scale he is at a 8 or 9/ still in terrible pain/dull, throbbing aches that was aggravated on sitting and walking/tenderness along the medial joint line and medial pseudo-laxity and swelled up to four times its size/left knee swelling/knee swelled up to the size of a cantalope; not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: hospitalization and required intervention for left knee degenerative joint disease and device malfunction.A pharmaceutical technical complaint (ptc) was initiated on 10-jan-2018 for synvisc one, batch 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Follow up information was received on 10-jan-2018.Global ptc number was added.Text was amended accordingly.Follow up information was received on 16-may-2018.Information regarding lab work (dated 14-dec-2017) was added.Text was amended accordingly.Additional information was received on 04-jun-2018 from the physician and case became medically confirmed.Past drugs, medical history, family history, concurrent conditions were added.Additional event of effusion, some painful popping and feelings of the knee and inflammatory reaction were added with details.Corrective treatment for still in pain/ on a pain scale he was at a 8 or 9/ still in terrible was added.Lab data was added.Hospital record details were added.Clinical course was updated and text was amended accordingly.Additional information was received on 22-aug-2018 from patient.Medical history was updated.Text amended accordingly.Additional information was received on 27-aug-2018 from a health care professional.Dose of synvisc one was updated from 1 df to 6ml, expiry date was added and indication was updated.Event onset of still in pain/ on a pain scale he is at a 8 or 9/ still in terrible pain was updated from 28-nov-2017 to 27-nov-2017, corrective treatment was added and event term was updated from still in pain/ on a pain scale he is at a 8 or 9/ still in terrible pain/dull, throbbing aches that was aggravated on sitting and walking/tenderness along the medial joint line and medial pseudo-laxity.Event term swelled up to four times its size was updated to swelled up to four times its size/left knee swelling/knee swelled up to the size of a cantaloupe, event onset date and corrective treatment was added.Event onset date of couldn't even bend his knee was added.Events still in pain/ on a pain scale he is at a 8 or 9/ still in terrible pain/dull, throbbing aches that was aggravated on sitting and walking/tenderness along the medial joint line and medial pseudo-laxity and swelled up to four times its size/left knee swelling/knee swelled up to the size of a cantalope; couldn't even bend his knee; effusion and some painful popping and feelings of the knee were updated as symptoms of inflammatory reaction.Additional event of left knee degenerative joint disease was added along with details.Seriousness criteria was updated.Patient's medical history, past drugs and concomitant medications were updated.Reporter causality was updated from unassessable to related.Clinical course was updated and text was amended accordingly.
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