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Right knee medial meniscus tear [tear of medial cartilage or meniscus of knee, current] ([joint lock]).Right knee pain [knee pain] ([diffuse pain], [condition aggravated]).Significant discomfort [discomfort].Ambulates with limp [limping].Hears popping [joint clicking].Limits adls like standing and walking [activities of daily living impaired].Swelling [joint swelling].Case narrative: initial information received on 13-sep-2018 from united states regarding an unsolicited valid serious case received from a consumer.This case involves a (b)(6) years old female patient who experienced right knee medial meniscus tear, right knee pain, significant discomfort, ambulates with limp, hears popping, limits adls like standing and walking and swelling, after receiving treatment with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included pap smear in 1983, asthma, colon polyp in 2016, depression on (b)(6) 2015, heartburn, ovarian cyst, neuromuscular disorder on (b)(6) 2015, thyroid disease, breast reduction surgery (b)(6) 2012, hysteroscopy, biopsy lung, thyroidectomy in (b)(6) 2002, cranial nerve decompression, uterine fibroid surgery, sulfa drug allergy, bactrim allergy, mri of knee on (b)(6) 2017 and tubal ligation.The patient's past medical treatment included synvisc one in left knee which provided complete relief.The patient's past vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing bilateral knee osteoarthritis.Patient is a non-tobacco user concomitant medications included paracetamol (tylenol [paracetamol]); salbutamol (proventil hfa [salbutamol]); azithromycin (zithromax); bupropion hydrochloride (wellbutrin); fluticasone propionate (flovent hfa); loratadine (claritin [loratadine]); metformin hydrochloride (glucophage); montelukast sodium (singulair); and levothyroxine sodium (synthroid).On (b)(6) 2017, patient received intra-articular injection of synvisc one (hylan g-f 20, sodium hyaluronate) in her right knee joint at 6ml 1x (batch number: unknown) for bilateral knee osteoarthritis.The injection site was sterilized and synvisc-one was injected.The patient tolerate the procedure well.On (b)(6) 2017, patient reported to the emergency department with right knee pain (latency: 11 days) and complained of increasing pain and swelling (latency: 11 days).The patient was prescribed naprosyn for pain.On (b)(6) 2017, patient reported to the clinic and stated that her pain was improving since her last visit but she was still in discomfort (latency: unknown).Further, she had catching and locking of her knee and also heard popping (latency: unknown) and ambulates with as limp (latency: unknown).The pain rated at 2/2.An mri was performed to evaluate the pathology of catching and locking symptoms.The patient also reported that after receiving the injection she has had difficulty ambulating and ambulates with limp (latency: few days) and has diffuse pain throughout the knee.On (b)(6) 2017, patient reported to the clinic with results of the mri.It was noted that the medial meniscus had flipped and there was disruption of the deep fibres and tearing of the anterior fibres at level of the joint.The patient stated that she wanted to proceed with surgery as all conservative treatments had failed.The risk and benefits of the surgery were discussed with the patient in detail.On (b)(6) 2017, patient underwent partial right knee medial meniscectomy for the right knee medial tear (latency: unknown).The patient was prepped for surgery in sterile fashion and general anesthesia was induced and preop antibiotics were given.An inferolateral portal was created with a scalpel, camera was introduced using a blunt trocar into the superolateral pouch.The trochlear groove was visualized and synovitis was noted which was debrided.The medial compartment was visualized and a degenerative tear was detected on medial meniscus.A inferomedial portal was created with the blade again, area was probed and biters and shavers were used to debride the meniscal flap down to smooth edges.The portals were closed with 3-0 nylon interrupted sutures and 10% of bupivacaine was infiltrated around each portal.The patient was awakened and sent to postoperative care unit in stable condition.On (b)(6) 2018, patient reported for follow up on her surgery and stated that the pain was well controlled, further her incision was healing well with no drainage.On (b)(6) 2018, patient had a steroid injection for pain which provided some relief but she continued to have pain that limits even simple adls like standing and walking (latency: unknown).On (b)(6) 2018, patient reported again for follow up on her surgery and stated she had pain on 10/10 which affected her quality of life and was in a lot of discomfort.Corrective treatment: partial right knee medial meniscectomy for the right knee medial tear; steroid injection and naprosyn for right knee pain; not reported for rest.Seriousness criterion: required intervention for right knee medial tear and right knee pain.Outcome: not recovered for right knee pain and discomfort; unknown for rest.A product technical complaint was initiated and results are pending for the same.
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Pyelonephritis [pyelonephritis] right knee medial meniscus tear [tear of medial cartilage or meniscus of knee, current] ([joint lock]) right knee pain [knee pain] ([condition aggravated], [diffuse pain], [tenderness], [pain upon movement]) significant discomfort [discomfort] ambulates with limp/ gait (mildly antalgic) abnormal [limping] hears popping [joint clicking] limits adls like standing and walking [activities of daily living impaired] pain is so bad that it has been affecting her sleep [sleep disturbance] numbness in the right foot [numbness in feet] decreased range of motion of the right knee/ decreased strength on extension and flexion against resistance secondary to pain [joint range of motion decreased] semimembranosus bursrtis [bursitis of knee] diarrhea [diarrhea] decreased appetite [decreased appetite] influenza [influenza] light-headedness [lightheadedness] chills [chills] fever [fever] urinary incontinence [urinary incontinence] abdominal pain [abdominal pain] pain in the right lateral thigh and lateral lower leg [pain in thigh] infected cyst of skin [cyst] spinal stenosis of lumbar region [spinal stenosis of lumbar region] blurred vision [blurred vision] hyperglycemia [hyperglycemia] joint effusion [joint effusion] synovitis [synovitis] swelling/ knee is swollen but not red [joint swelling] case narrative: initial information received on 13-sep-2018 from united states regarding an unsolicited valid legal serious case received from a consumer.This case involves a 54 years old female patient who experienced right knee medial meniscus tear, right knee pain, significant discomfort, ambulates with limp, hears popping, limits adls like standing and walking and swelling, pyelonephritis, pain is so bad that it has been affecting her sleep, numbness in the right foot, decreased range of motion of the right knee/ decreased strength on extension and flexion against resistance secondary to pain, semimembranosus bursritis, diarrhea, decreased appetite, influenza, light-headedness, chills, fever, urinary incontinence, abdominal pain, pain in the right lateral thigh and lateral lower leg, infected cyst of skin, spinal stenosis of lumbar region, blurred vision, hyperglycemia, joint effusion and synovitis after receiving treatment with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included pap smear in 1983, vitamin d deficiency on (b)(6) 2007, allergic rhinitis on (b)(6) 2007, gastroesophageal reflux disease on (b)(6) 2010, macromastia on (b)(6) 2012, back pain on (b)(6) 2012, hoarseness, recurrent on (b)(6) 2014, anxiety and depression on (b)(6) 2014, prediabetes on (b)(6) 2014, asthma, colon polyp in 2016, depression, postoperative hypothyroidism, morbid obesity on (b)(6) 2015, heartburn, ovarian cyst, neuromuscular disorder on (b)(6) 2015, thyroid disease, breast reduction surgery 12-dec-2012, hysteroscopy, biopsy lung, thyroidectomy in (b)(6) 2002, paresthesia of both hands on (b)(6) 2015, cranial nerve decompression, uterine fibroid surgery, sulfa drug allergy, bactrim allergy, mri of knee on (b)(6) 2017, tubal ligation, neck pain, right ankle pain, anemia, wheezing, tight and productive cough, nasal congestion, tubular adenoma on (b)(6) 2016.The patient's past medical treatment included synvisc one in left knee which provided complete relief.Her past medication included zoloft, trazodone, hydroxyzine and fexofenadine.She had concurrent conditions of serotonin syndrome.The patient's past vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing bilateral knee osteoarthritis.Patient is a non-tobacco user.Concomitant medications included paracetamol (tylenol [paracetamol]); salbutamol (proventil hfa [salbutamol]); azithromycin (zithromax); bupropion hydrochloride (wellbutrin); fluticasone propionate (flovent hfa); loratadine (claritin [loratadine]); metformin hydrochloride (glucophage); montelukast sodium (singulair); and levothyroxine sodium (synthyroid), prednisone (deltasone), oxycodone hydrochloride (oxicodone), ferrous sulphate, ketorolac tromethamine (toradol) and melatonin.Her family history included diabetes, hypertension, heart attack in her mother.Her paternal aunt and paternal grandmother also had breast cancer.Her sister had history of diabetes, hypertension and asthma.On (b)(6) 2017, patient received intra-articular injection of synvisc one (hylan g-f 20, sodium hyaluronate) in her right knee joint at 6ml 1x (batch number: unknown) for bilateral knee osteoarthritis.The injection site was sterilized and synvisc-one was injected.The patient tolerate the procedure well.On 27- nov-2017, patient reported to the emergency department with right knee pain (latency: 11 days) and complained of increasing pain and swelling (latency: 11 days).It was also reported by the patinet that pain was so bad that it had been affecting her sleep.It was sated by her that her knee was swollen but not red.Patient also complained about some numbness in the right foot.On the same day during examination, decreased range of motion of the right knee was observed.She had decreased strength on the extension and flexion against resistance secondary to pain.It was limited internal and external rotation of the right knee secondary to pain.She was having worsening right knee pain.The patient was prescribed naprosyn for pain.On (b)(6) 2017, patient reported to the clinic and stated that her pain was improving since her last visit but she was still in discomfort (latency: unknown).Further, she had catching and locking of her knee and also heard popping (latency: unknown) and ambulates with as limp (latency: unknown).The pain rated at 2/2.An mri was performed to evaluate the pathology of catching and locking symptoms.The patient also reported that after receiving the injection she has had difficulty ambulating and ambulates with limp (latency: few days) and has diffuse pain throughout the knee.On (b)(6) 2017, patient reported to the clinic with results of the mri.It was noted that the medial meniscus had flipped and there was disruption of the deep fibres and tearing of the anterior fibres at level of the joint.In the mri reports, it was also observed that patient had semimembranous bursitis.Also suffering from joint effusion with synovitis.On (b)(6) 2017, patient ordered orthosis and was delivered neoprene knee sleeve.The patient stated that she wanted to proceed with surgery as all conservative treatments had failed.The risk and benefits of the surgery were discussed with the patient in detail.On 27-dec-2017, patient underwent partial right knee medial meniscectomy for the right knee medial tear (latency: unknown).The patient was prepped for surgery in sterile fashion and general anesthesia was induced and preop antibiotics were given.An inferolateral portal was created with a scalpel, camera was introduced using a blunt trocar into the superolateral pouch.The trochlear groove was visualized and synovitis was noted which was debrided.The medial compartment was visualized and a degenerative tear was detected on medial meniscus.A inferomedial portal was created with the blade again, area was probed and biters and shavers were used to debride the meniscal flap down to smooth edges.The portals were closed with 3-0 nylon interrupted sutures and 10% of bupivacaine was infiltrated around each portal.The patient was awakened and sent to postoperative care unit in stable condition.It was also stated she had decreased appetite since her knee surgery.On (b)(6) 2018, patient reported for follow up on her surgery and stated that the pain was well controlled, further her incision was healing well with no drainage.On (b)(6) 2019, patient complained of lightheadedness and subjective chills.On the same day, she also complained of pyelonephritis and influenza.Her lab reports on (b)(6) 2018 stated that blood glucose was 101 mg/dl, mch was 27.3 pg and rdw was 14.6 %.On (b)(6) 2008, she stated that her knee was no better despite these treatments and the surgery.She was having generalized tenderness to palpitation around the knee.On (b)(6) 2018, patient had a steroid injection for pain which provided some relief but she continued to have pain that limits even simple adls like standing and walking (latency: unknown).On (b)(6) 2018, patient reported again for follow up on her surgery and stated she had pain on 10/10 which affected her quality of life and was in a lot of discomfort.On (b)(6) 2018, mch was 27.7 pg and rdw was 14.4 %.On 30-aug-2018, glucose was 101 mg/dl, rdw was 14.4 %, urine was cloudy.On (b)(6) 2018, glucose was estimated average glucose was 154 mg/dl, blood glucose was 139 mg/dl, gfr was 57.On (b)(6) 2018, she reported about her lumbar stenosis.She stated that she had low back pain and right lower extremity pain that started about 8 weeks ago she stated that she had been unable to continue work as a bus driver since that time.She stated she was unable to get up from sitting and had terrible pain in her back.She reported that the pain started up in the lower thoracic area and radiates down into the sacral area and then radiated out to the right hip.She also noted pain in the right lateral thigh and lateral lower leg.She got numbness in the toes of the right foot and had also noticed some weakness in her right leg.She also reported about the problem of urinary urgency.On her visit on (b)(6) 2018, she complained about blurred vision and hyperglycemia.On (b)(6) 2018, she was also observed with gait (mildly antalgic) abnormal.On (b)(6) 2018, blood glucose was 530 mg/dl, blood sodium was 132, glucose urine was 3+ and ketone in urine was moderate.Corrective treatment: partial right knee medial meniscectomy for the right knee medial tear; steroid injection and naprosyn, meloxicam (mobic) for right knee pain, ceftriaxone for pyelonephritis, oseltamivir for influenza, gabapentin for spinal stenosis of lumbar region and lantus for hyperglycemia; not reported for rest.Seriousness criterion: intervention required for pyelonephritis, right knee medial tear and right knee pain.Outcome: recovered for fever; not recovered for spinal stenosis of lumbar region, right knee pain and discomfort; unknown for rest.A product technical complaint (ptc) was initiated and results were pending for the same.Follow up was received on 20-sep-2018.No new information was received.Additional information was received on 19-feb-2019 from lawyer.Events of pain is so bad that it has been affecting her sleep, numbness in the right foot, decreased range of motion of the right knee/ decreased strength on extension and flexion against resistance secondary to pain, semimembranosus bursritis, diarrhea, decreased appetite, influenza, light-headedness, chills, fever, urinary incontinence, abdominal pain, pain in the right lateral thigh and lateral lower leg, infected cyst of skin, spinal stenosis of lumbar region, blurred vision, hyperglycemia, joint effusion and synovitis added.Medical history was added.Concomitant medications added.Clinical course updated.Text amended accordingly.
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