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Device malfunction [device malfunction]; swelling in knee [swelling of l knee]; muscle spasms shooting down the leg [muscle spasms]; instability [joint instability]; fatigue [fatigue]; fever [fever]; pain/pain in knee/aching/medial joint line tenderness [knee pain]; stiffness [stiff knees]; fluid in knee /knee effusion [effusion (l) knee]; weakness [weakness].Case narrative: this unsolicited case from united states was received on 22-dec-2017 from a consumer (patient wife).This case concerns a 66 years old male patient who received treatment with synvisc one and later after unknown latency muscle spasms shooting down the leg, instability, fatigue, weakness, fever, pain/pain in knee/aching/medial joint line tenderness, swelling in knee, stiffness and fluid in knee/knee effusion.Also device malfunction was identified for the reported lot number.The patient's past medical history included alcohol use with ethanol less than 1 drink per day, arthroscopy, meniscectomy, hypercholesterolemia, hypertension, cystitis, tonsillectomy, cholecystectomy, nasal septal operation and hernia repair.The patient's family history included cancer with father and ischemic heart disease with mother.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing type 2 diabetes mellitus, former-smoker, antalgic gait, range of motion: 120 degrees and arthralgia.He had no known allergies.On (b)(6) 2018, patient had an x-ray which revealed no fractures, no dislocations, subchondral cyst and sclerosis.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown) into the left knee.On an unknown date in (b)(6) 2017, soon after receiving the injection, the patient experienced pain and swelling in the knee.The patient was taking hydrocodone bitartrate/paracetamol (norco) for pain, as well as meloxicam.He was also said to take over the counter medications for pain.On an unknown date in (b)(6) 2017, the patient experienced a fever.His physician was currently in the process of scheduling the patient for aspiration of the affected knee.No lab work had been performed to date.The patient was not hospitalized and had not seen his physician to date.It was reported that the patient had not been prescribed antibiotics.He had needed a cane for ambulation since the symptoms began.His symptoms were still present, but his fever had resolved.On an unknown date in 2017, after unknown latency of receiving the injection, the patient had pain with intensity: 8/10 and with aching and burning quality with signs and symptoms of swelling, weakness, stiffness, and instability throughout the day.Patient felt better with medications.Patient had mild knee effusion.Patient further reported that pain got worsened with activity.Patient had sharp muscle spasms shooting down the leg, aching, and constant with signs and symptoms of weakness, stiffness, and gait.Patient also experienced fatigue.Final diagnosis was mild fluid in knee/knee effusion, stiffness, swelling in knee, pain/pain in knee/aching/medial joint line tenderness, fever, fatigue, instability, muscle spasms shooting down the leg and device malfunction corrective treatment: cane for ambulation for swelling in knee; hydrocodone bitartrate/paracetamol (norco), meloxicam, over the counter medications, cane for ambulation for pain/pain in knee/aching/medial joint line tenderness; not reported for rest of the events.Outcome: recovered for fever and not recovered for swelling in knee, pain/pain in knee/aching/medial joint line tenderness, stiffness, fluid in knee/knee effusion and weakness; unknown for all other events.A pharmaceutical technical complaint (ptc) was initiated 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: disability for device malfunction and swelling in knee.Follow up was received on 29-dec-2017.Global ptc number was added.Additional information received on 02-oct-2018 from lawyer.Events of stiffness, instability, fatigue, weakness and muscle spasms shooting down the leg were added.Event verbatim of fluid in knee/knee effusion, and pain/pain in knee/aching/medial joint line tenderness was updated.Seriousness criteria of device malfunction and pain/pain in knee/aching/medial joint line tenderness was updated.Clinical course was updated and text amended accordingly.
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Device malfunction [device malfunction] total knee replacement [total knee replacement] swelling in knee [swelling of l knee] ([condition worsened]) unable to perform on eor more adl's independently [activities of daily living impaired] muscle spasms shooting down the leg [muscle spasms] instability/ shaky [joint instability] fatigue/ tired /lethargic [fatigue] fever/ fever of 100.2 [fever] weakness/ general weakness/ knee still feels weak/ decreased strength/weakness to left hip/ atrophy still noted l hip, glute [weakness] left sided lbp [lumbar pain] decreased rom [joint range of motion decreased] pain with functional mobility/ functionally limited by left knee pain/ left hip pain when he puts pressure on it, walking.[pain upon movement] sciatica/ left sciatica pain [sciatica] left knee discomfort [discomfort in joints] radiculopathy [radiculopathy] ingrown toenail [toenail hypertrophy] blood pressure may be too low [blood pressure low] pain/pain in knee/aching/medial joint line tenderness/ pain in hip/ glute pain/ continued persistent knee pain/ inferomedial knee pain/ dull and sharp intermittent knee pain/ knee pain score (b)(4)/ throbbing pain [knee pain] ([condition worsened]) stiffness/ joint stiffness at end range of flexion [stiff knees] fluid in knee /knee effusion [effusion (l) knee] warm to touch [joint warmth] mild redness to p/op left knee [injection site joint erythema] red blood cell count low [red blood cell count low] hemoglobin low [hemoglobin low] hematocrit low [hematocrit low] sedimentation rate increased [sedimentation rate increased] c-reactive protein increased [c-reactive protein increased] white blood cell count increased [white blood cell count increased] blood glucose increased [blood glucose increased] blood urea nitrogen increased [blood urea nitrogen increased] blood creatinine increased [blood creatinine increased] chloride high [chloride high] blood calcium low [calcium low] glomerular filtration rate low [glomerular filtration rate low] neutrophil percentage increased [neutrophil percentage increased] lymphocytre percenatge decreased [lymphocyte percentage decreased] urine appearance hazy [urine abnormality] toe is oozing some purulent drainage [purulent discharge] toe is red [redness] toe painful [pain in toe] case narrative: this unsolicited legal case from united states was received on (b)(6) 2017 from a consumer (patient wife).This case involves a 66 years old male patient (182 cm and 93 kg) who experienced device malfunction, total knee replacement, swelling in knee, muscle spasms shooting down the leg, instability, fatigue/ tired /lethargic, fever, pain/pain in knee/aching/medial joint line tenderness/ pain in hip/ glute pain/ continued persistent knee pain/ inferomedial knee pain/ dull and sharp intermittent knee pain/ knee pain score 6/ throbbing pain, stiffness/ joint stiffness at end range of flexion, fluid in knee /knee effusion, weakness/ general weakness/ knee still feels weak/ decreased strength/weakness to left hip/ atrophy still noted l hip, glute, left sided lbp, decreased rom, pain with functional mobility/ functionally limited by left knee pain/ left hip pain when he puts pressure on it, walking., warm to touch, sciatica/ left sciatica pain, mild redness to p/op left knee, left knee discomfort, radiculopathy, unable to perform on eor more adl's independently, blood pressure may be too low, red blood cell count low, hemoglobin low, hematocrit low, sedimentation rate increased, c-reactive protein increased, white blood cell count increased, blood glucose increased, blood urea nitrogen increased, blood creatinine increased, chloride high, blood calcium low, glomerular filtration rate low, neutrophil percentage increased, lymphocyte percentage decreased, urine appearance hazywhile he was treated with with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included alcohol use with ethanol less than 1 drink per day, arthroscopy, meniscectomy, hypercholesterolaemia, hypertension, cystitis, tonsillectomy, cholecystectomy, nasal septal operation, hernia repair, nephrolithiasis, benign prostatic hyperplasia, chronic obstructive pulmonary disease, gastrooesophageal reflux disease, anxiety, obesity, rectal fistula repair, knee operation with 4 knee surgery, tuberculosis, back disorder, food allergy with milk and soy, alcohol use with 1 per day, dyspnoea, dyslipidaemia, depression and drug hypersensitivity with heparin sodium.The patient's family history included neoplasm malignant with father, myocardial ischaemia with mother, neoplasm malignant with father, myocardial infarction with mother, coronary artery disease with brother, type 2 diabetes mellitus with brother and stent placement with brother.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing type 2 diabetes mellitus, ex-tobacco user, gait disturbance, joint range of motion decreased and arthralgia.Concomitant medications included amlodipine; aspirin [acetylsalicylic acid]; baclofen; hydrocodone; metformin; meloxicam for inflammation; hydrochlorothiazide, triamterene (maxzide) for diuretic therapy; adenosine (tricor)for blood pressure increased; finasteride; lansoprazole for gastrooesophageal reflux disease; amlodipine besilate (norvasc) for blood pressure measurement; nitrofurantoin (macrodantin); ranitidine hcl; morniflumate (flomax) for bladder disorder; colesevelam hydrochloride (welchol); minoxidil ; arformoterol tartrate (brovana); budesonide; albuterol sulfate for chronic obstructive pulmonary disease; zolpidem tartrate (ambien cr) for sleep disorder; acebutolol ; atorvastatin calcium (lipitor) for blood cholesterol; salbutamol sulfate (proair hfa); baclofen; and bethanechol chloride.On(b)(6)2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown) into the left knee.On an unknown date in (b)(6)2017, soon after receiving the injection, the patient experienced pain and swelling in the knee.The patient was taking hydrocodone bitartrate/paracetamol (norco) for pain, as well as meloxicam.He was also said to take over the counter medications for pain.On an unknown date in (b)(6)2017, the patient experienced a fever.His physician was currently in the process of scheduling the patient for aspiration of the affected knee.No lab work had been performed to date.The patient was not hospitalized and had not seen his physician to date.It was reported that the patient had not been prescribed antibiotics.He had needed a cane for ambulation since the symptoms began.His symptoms were still present, but his fever had resolved.On an unknown date in (b)(6) , after unknown latency of receiving the injection, the patient had pain with intensity: 8/10 and with aching and burning quality with signs and symptoms of swelling, weakness, stiffness, and instability throughout the day.Patient felt better with medications.Patient had mild knee effusion.Patient further reported that pain got worsened with activity.Patient had sharp muscle spasms shooting down the leg, aching, and constant with signs and symptoms of weakness, stiffness, and gait.Patient also experienced fatigue.On (b)(6)2017, lab results were neutrophil percentage was 67.9 (high), lymphocyte percentage was 20.2 (low), urine appearance was hazy, c-reactive protein was 0.5 (high).On (b)(6)2018, patient had blood pressure of 146/65 and pulse was 70.Left total knee arthroplasty procedure was performed.The left lower extremity was prepped andf drained in the ususal sterile fashion.Midline incision was made.Medial release of the deep mcl was performed as well as subperiosteal , acl and pcl resected.Intramedullary rod placed.It was pinned and a distal femoral cut was made.This showed intracompartmental arthritis.After the four and one cuts were made, the trochlear chamfer guide was then placed on the knee and secured with two screws.Lug holes were drilled , copiously irrigate dthe knee, punched the tibia in the middle third of the tibial tubercle, placed a bone plug, achieved homeostasis on the posterior capsule and with the knee dry, cemented the components into positin and placed appropriate size poly as well.At this point, mixture of exparel, duramorph, ketorolac and marcaine which was 60 ccs was injected into the posterior capsule , the medial and lateral glutter, the quad tendon, the patella tendon, the periosteum and the skin.Drain was placed.Three layer closure was performed with 0 quill, 2-0 vicryl and skin staples.Sterile dressing was placed.The patient was awakened and taken to recovery.The skin infiltration site was infiltrated with 1% lidocaine.A 21 guage short bevel needle was inserted at in plane lateral to medial direction toward the cephenous nerve.At this point 0.5% ropivacaine and 2 mg decadron was intermediary injected with frequent negative needle aspirations.Patient was reported to be doing well postoperatively.On (b)(6)2018, radiology results of knee ap and lateral section revealed femoral and tibial components were in satisfactory position.Patient was discharged on (b)(6)2018 and was asked to continue eliquis 2.5 mg twice daily for prophylaxis.On (b)(6)2018, wbc was 13.2 (high), rbc was 3.64 (low), hemoglobin was 11.2 (low), hematocrit was 33.1 (low), glucose was 171(high), bun was 33 (high), creatinine was 1.7 (high), chloride was 108 (high), calcium was 8.0 (low), egfr was 41 (low).On (b)(6)2018, patient was admitted to home health services for after care following joint replacement surgery.It was reported that the patient was unable to perform one or more adl's independently.During home care, knee incision was cleaned genltly with soap and water fdaily leaving prineo intact, pat dry and leave ota.On (b)(6)2018, patient's wife informed tha the patient had low grade temperature mainly at night, not reaching above 100.4, maximum temp reported was 100.2.Patient had an ingrown toenail that was addressed by primary care prior to surgery.She stated that the toe was oozing some purulent drainage, was still red and somewhat painful for patient.On (b)(6)2018, patient was asked to continue bactrim ds po bid x1 more week.Patient fever was reported to be 99 f that night.Patient reported of being very tired and being lethargic.Spouse was concerned that patient's blood pressure may be too low with pain meds and with bp meds.On (b)(6)2018, patient continued to have pain at severe levels 8/10-10/10.He reported that medications aren't even touching it.He saw the primary care for toe infection and was on more medications and topical.On (b)(6)2018, patient was seen by the primary care physician and he discontinued bactrim and started on clindamycin.On(b)(6)2018, patients lab values were rbc count was 3.65 (low), hemoglobin was 11.0 (low), hematocrit was 33.5 (low), sedimentation rate was 53 d (high) c-reactive protein was 7.7 (high).On (b)(6)18, patient reported that his pain was unbearable.He reported that pain medication was not helping and something must be done.He had been icing and elevating.On (b)(6)2018, patient's spouse reported of still running fever at night.On (b)(6)2018, patient was started on meloxicam 15 mg tablet and restarted on gabapentin to help manage pain.On (b)(6)2018, patient reported that his pain was improving, but he was shaky and uncomfortable.He had additional toenail removal today.On (b)(6)2018 , during discharge patient was reported to have had achieved full rom 0-120 degress in knee.He had difficulty throughout care plan with plan management and was treated with e-stim for pain.Post discharge instructions and accurate medication list were given to the patient and family to continue providing care as assistance.On (b)(6)18, it was reported that patient had left sided knee pain , hip pain , low back pain, knee still felt weak, generalized weakness , decreased strength, decreased rom, increased edema, warm to touch, complaint of sciatic pain possible contributing to increased left lq pain, pain with functional mobility.Patient underwent therapeutic exercises (rom, strength, endurance , stability), therapeutic activity, gait training, neuromuscular rehabilitation, manual therapy, splinting/taping, patient education, electrical stimulation, ultrasound/phonophoresis, laser, cryotherapy, hot packs to improve pain relief, decrease inflammation, increase blood flow, improve tissue healing.On the same day, patient still complained of left sided lbp, left glute and left knee pain.On 09-may-2018, patient had limitations secondary to lbp, sciatica, weakness to left hip and core as well.Still palpable warmth mild redness to preoperative left knee.On (b)(6)2018 patient reported of left knee feeling better but complained of some low back pain.On (b)(6) 2018, patient reported some stiffness and throbbing at night but he felt better once walking around.On (b)(6)2018, lab results were neutrophil percentage was 68.7 (high), lymphocyte percentage was 19.2 (low), sedimentation rate was 3 d.On (b)(6)2018, patient reported of mild lbp and left knee pain and discomfort.On (b)(6)2018, patient reported increased swelling from walking while out of town.On (b)(6)2018, patient had continued persistent knee pain.On (b)(6)18, patient had inferomedial knee pain.On (b)(6)18, patient had increased soreness today after mowing the lawn over the weekend.On(b)(6)18, patient experienced tweaking at home while putting on bed sheets, joint stiffness at end range of flexion and was functionally limited by left knee pain.On (b)(6)2018, patient reported of left hip pain when he puts pressure on it or while walking.On (b)(6)2018 patient reported of radiculopathy/ sciatica.On (b)(6)2018, patient had an x-ray which revealed no fractures, no dislocations, subchondral cyst and sclerosis.Corrective treatment: cane for ambulation for swelling in knee; hydrocodone bitartrate/paracetamol (norco), meloxicam, over the counter medications, cane for ambulation for pain/pain in knee/aching/medial joint line tenderness; e-stim, gabapentin, bactrim ds for pain, exparel, duramorph, ketorolac and marcaine for total knee replacement ; not reported for rest of the events outcome: recovered for fever and decreased rom; recovering for swelling in knee, not recovered for, pain/pain in knee/aching/medial joint line tenderness, stiffness, fluid in knee/knee effusion and weakness, device malfunction; unknown for all other events.Seriousness criteria: disability for swelling in knee and unable to perform one or more adl's independently and device malfunction; medically significant, intervention required and hospitalization for total knee replacement.A pharmaceutical technical complaint (ptc) was initiated 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 (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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented follow up was received on (b)(6)2017.Global ptc number was added.Additional information received on (b)(6)2018 from lawyer.Events of stiffness, instability, fatigue, weakness and muscle spasms shooting down the leg were added.Event verbatim of fluid in knee/knee effusion, and pain/pain in knee/aching/medial joint line tenderness was updated.Seriousness criteria of device malfunction and pain/pain in knee/aching/medial joint line tenderness was updated.Clinical course was updated and text amended accordingly.Additional information received on(b)(6)2018 from lawyer.New events of left sided lbp, total knee replacement, decreased rom, pain with functional mobility/ functionally limited by left knee pain/ left hip pain when he puts pressure on it, walking., warm to touch, sciatica/ left sciatica pain, mild redness to p/op left knee, left knee discomfort, radiculopathy, unable to perform one or more adl's independently, and blood pressure may be too low were added with details.Medical history was updated.Concomitant medications were added.Clinical course updated and text amended accordingly.
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