| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Contusion (1787); Skin Discoloration (2074); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
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| Event Date 11/09/2017 |
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Event Type
Injury
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Event Description
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Decreased range of motion of right knee [joint range of motion decreased], derangement of collateral ligament of right knee [ligament disorder], knee pain/left and right knee pain/chronic pain of left knee [knee pain], bilateral knee effusions [knee effusion], both knees were swollen [swelling of knees], traumatic arthritis of right knee- primary [knee arthritis], difficulty ambulating/decreased ambulation status [difficulty in walking], bruise that developed around the injection site (size of a dime) [bruise], skin discoloration at the injection site [skin discoloration], primary localized osteoarthrosis of right lower leg [osteoarthrosis, localised, primary, involving lower leg], plantar fasciitis, bilateral [plantar fasciitis], weakness of right leg [weakness in extremity].Case narrative: initial information received on 17-sep-2018 regarding an unsolicited valid serious case received from a health care professional from united states.This case is linked to case (b)(4) (same patient).This case involves a (b)(6) female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and after 8 hours experienced knee pain/left and right knee pain/chronic pain of left knee, bilateral knee effusions, difficulty ambulating/decreased ambulation status, both knees were swollen, after 1 month had traumatic arthritis of right knee- primary, after unknown latency had bruise that developed around the injection site (size of a dime) , skin discoloration at the injection site, after 3 months had primary localized osteoarthrosis of right lower leg, after 4 months had decreased range of motion of right knee, weakness of right leg, derangement of collateral ligament of right knee and after 5 months had plantar fasciitis, bilateral.The patient's past medical history included obesity from (b)(6) 2014 to (b)(6) 2015, back pain, varicose vein, carpal tunnel decompression, gastrectomy, hernia repair, hysterectomy, tendon sheath incision and foot operation.Patient was allergic to penicillin (nausea), escitalopram with hives, swelling and rash and oxycodone hydrochloride (hives) and latex, natural rubber (rash).The patient's family history included diabetes mellitus, cardiac disorder and renal failure with father.The patient's past vaccination(s) was not provided.At the time of the event, the patient had ongoing arthralgia on (b)(6) 2015, somnolence on (b)(6) 2014, gastrooesophageal reflux disease on (b)(6) 2014, obesity on (b)(6) 2015, arthritis on (b)(6) 2015, knee deformity on (b)(6) 2015, non-tobacco user, alcohol use occasionally, arthralgia, muscular weakness, musculoskeletal stiffness, tenderness with in both knees, crepitations with in both knees, osteoarthritis with most severe in the right lateral compartment.Concomitant medications included biotin; calcium citrate; furosemide (lasix); tocopherol (vitamin e); pantoprazole sodium sesquihydrate (protonix); aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, riboflavin, thiamine hydrochloride (b-complex); cyanocobalamin (vitamin b-12); diclofenac sodium; econazole nitrate; meloxicam (mobic); phentermine hydrochloride (adipex-p); macrogol 3350 (glycolax); ibuprofen (advil) for arthralgia; and promethazine (phenergan) for nausea.Patient had previously received synvisc one bilaterally on (b)(6) 2016 and (b)(6) 2017.On (b)(6) 2017, at 15:45, patient received intra-articular synvisc one injections, at a dose of 6ml, once, bilaterally for primary osteoarthritis of right and left knee.The patient was first prepped aseptically with povidone-iodine swabsticks and then synvisc one injection was given under sterile technique using a 22g x 1.5 needle from the superolateral aspect of the bilateral knee joint in the supine position.Patient had no adverse reactions to the medication.Pain decreased.Patient was instructed to apply ice to the joint for 20 minutes and avoid strenuous activities for 24-36 hours following the injection.Patient was warned of possible blood sugar and/or blood pressure changes during that time.Following that time, patient could resume regular activities.On (b)(6) 2017, patient had bilateral knee effusions, both knees were swollen, was having pain and difficulty ambulating.Right knee pain was worse than left knee pain.Patient was interested in having a right knee replacement, but not until february.Patient has been taking mobic 15mg once a day.On the same day, the patient was prepped aseptically with povidone iodine swabsticks.The 30cc's of cloudy joint fluid was aspirated from the superolateral aspect of the right and left knee joint using a 18g x 1.5 needle in sterile fashion without complication.Following aspiration, a diagnostic and therapeutic injection of 1 :3cc kenalog/marcaine was given under sterile technique in the supine position.Patient reported decreased pain and swelling following the injections.On the same day, outpatient cultures were sent off from bilateral knee aspirations which were negative.On 11-dec-2017, one lot of synvisc one was voluntary recalled due to an ongoing investigation which revealed the presence of microbial, methylobacterium thiocyanatum, and alpha proteobacterial class, aerobic, gram negative rod.It was possible that the patient received an injection from the recalled lot.On (b)(6) 2017, patient again visited for follow up of both knees.Patient was doing well since the steroid injection administered on (b)(6) 2017.Patient's pain on pain scale was 6 over the past 3 days.On the same day, patient was diagnosed with traumatic arthritis of right knee- primary.Patient was recommended right knee total knee replacement.On an unknown date, patient had a bruise that developed around the injection site (size of a dime) which resolved.On an unknown date in (b)(6) 2018, patient developed a skin discoloration at the injection site.Patient reported no increased pain, just skin discoloration.On (b)(6) 2018, patient visited again for left and right knee pain and primary discoloration of skin around aspiration sites in bilateral knees.As of (b)(6) 2018, patient's pain on pain scale was 7 over the past 3 days.On (b)(6) 2018, patient had total right knee replacement.It was reported that patient's preoperative diagnosis was right arthritis, traumatic, degenerative joint disease (djd) knee and genu varum (acquired).On (b)(6) 2018, patient had primary localized osteoarthrosis of right lower leg.On (b)(6) 2018, patient had decreased ambulation status, weakness of right leg, decreased range of motion (rom) of right knee and pain in knee.On (b)(6) 2018, patient had derangement of collateral ligament of right knee.On (b)(6) 2018, patient visited again for right knee post operation evaluation and was diagnosed with chronic pain of left knee and plantar fasciitis, bilateral.Patient was also diagnosed with right arthritis, traumatic, djd knee and genu varum (acquired).On the same day, patient's knee radiographs showed postoperative changes identified relating to a prior right knee arthroplasty procedure.Prostheses appeared unremarkable.On the left, there was tibiofemoral joint space narrowing and spurring again seen, as well as minimal superior patellar spurring.Osseous structures demonstrate no evidence of recent or healing fracture, lytic destructive process, development of abnormal periprosthetic lucency, or other significant detrimental interval change since the examinations referenced above.Some minor soft tissue fullness in the suprapatellar bursa on the right side was consistent with a joint effusion, decreased in volume since (b)(6) 2018.No joint effusion on the left.On the same day, patient was again aspirated and a diagnostic and therapeutic injection of 2:5cc kenalog/marcaine was given under sterile technique in the supine position.Patient had no adverse reactions to the medication.Pain decreased.Patient was instructed to apply ice to the joint for 20 minutes and avoid strenuous activities for 24-36 hours following the injection.Patient was also trained for custom orthotic/brace adjustment and fitting and visco heel cups.Patient was also given meloxicam.Patient was treated with meloxicam (mobic), bupivacaine hydrochloride (marcaine) and triamcinolone acetonide (kenalog) for knee pain/left and right knee pain/chronic pain of left knee and both knees were swollen, bupivacaine hydrochloride and triamcinolone acetonide for bilateral knee effusions, both knees were swollen, traumatic arthritis of right knee- primary, derangement of collateral ligament of right knee and decreased range of motion of right knee; not reported for other events.Outcome: recovering for knee pain/left and right knee pain/chronic pain of left knee and both knees were swollen, not recovered for difficulty ambulating/decreased ambulation status, decreased range of motion of right knee, derangement of collateral ligament of right knee and primary localized osteoarthrosis of right lower leg, recovered for bruise that developed around the injection site (size of a dime), unknown for other events.A pharmaceutical technical complaint was initiated with results pending for the same.Seriousness criteria: required intervention for derangement of collateral ligament of right knee, decreased range of motion of right knee, knee pain/left and right knee pain/chronic pain of left knee and both knees were swollen, bilateral knee effusions and traumatic arthritis of right knee- primary.
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Event Description
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Decreased range of motion of right knee [joint range of motion decreased] derangement of collateral ligament of right knee [ligament disorder] knee pain/left and right knee pain/chronic pain of left knee/right knee pain [knee pain] bilateral knee effusions [knee effusion] both knees were swollen/edema [swelling of knees] traumatic arthritis of right knee- primary [knee arthritis] difficulty ambulating/decreased ambulation status [difficulty in walking] bruise that developed around the injection site (size of a dime) [bruise] skin discoloration at the injection site/black, scaly discolorization [skin discoloration] primary localized osteoarthrosis of right lower leg [osteoarthrosis, localised, primary, involving lower leg] plantar fasciitis, bilateral [plantar fasciitis] weakness of right leg [weakness in extremity] case narrative: initial information received on 17-sep-2018 regarding an unsolicited valid serious legal case received from a health care professional from united states.This case is linked to case (b)(4).This case involves a 54 years old female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and after 8 hours experienced knee pain/left and right knee pain/chronic pain of left knee, bilateral knee effusions, difficulty ambulating/decreased ambulation status, both knees were swollen/edema, after 1 month had traumatic arthritis of right knee- primary, after unknown latency had bruise that developed around the injection site (size of a dime) , skin discoloration at the injection site/black, scaly discolorization, after 3 months had primary localized osteoarthrosis of right lower leg, after 4 months had decreased range of motion of right knee, weakness of right leg, derangement of collateral ligament of right knee and after 5 months had plantar fasciitis, bilateral.The patient's past medical history included obesity from (b)(6) 2014 to (b)(6) 2015, back pain, varicose vein, carpal tunnel decompression, gastrectomy, hernia repair, hysterectomy, tendon sheath incision, acquired genu varum of left and right knee (since (b)(6) 2015), knee injury by horse (8 years ago), b heel spur removal and foot operation.Patient was allergic to penicillin (nausea), escitalopram with hives, swelling and rash and oxycodone hydrochloride (hives) and latex, natural rubber (rash).The patient's family history included diabetes mellitus, cardiac disorder and renal failure with father.The patient's past vaccination(s) was not provided.At the time of the event, the patient had ongoing arthralgia on (b)(6) 2015, somnolence on (b)(6) 2014, gastrooesophageal reflux disease on (b)(6) 2014, obesity on (b)(6) 2015, arthritis on (b)(6) 2015, knee deformity on 02-dec-2015, non-tobacco user, alcohol use occasionally, arthralgia, muscular weakness, musculoskeletal stiffness, tenderness with in both knees, crepitations with in both knees, osteoarthritis with most severe in the right lateral compartment.Concomitant medications included biotin; calcium citrate; furosemide (lasix); tocopherol (vitamin e); pantoprazole sodium sesquihydrate (protonix); aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, riboflavin, thiamine hydrochloride (b-complex); cyanocobalamin (vitamin b-12); diclofenac sodium; econazole nitrate; meloxicam (mobic); phentermine hydrochloride (adipex-p); macrogol 3350 (glycolax); ibuprofen (advil) for arthralgia; and promethazine (phenergan) for nausea.Patient had previously received synvisc one bilaterally on (b)(6) 2016 and(b)(6) 2017.On (b)(6) 2017, at 15:45, patient received intra-articular synvisc one injections, at a dose of 6ml, once (lot: unknown) bilaterally for primary osteoarthritis of right and left knee.The patient was first prepped aseptically with povidone-iodine swabsticks and then synvisc one injection was given under sterile technique using a 22g x 1.5 needle from the superolateral aspect of the bilateral knee joint in the supine position.Patient had no adverse reactions to the medication.Pain decreased.Patient was instructed to apply ice to the joint for 20 minutes and avoid strenuous activities for 24-36 hours following the injection.Patient was warned of possible blood sugar and/or blood pressure changes during that time.Following that time, patient could resume regular activities.On (b)(6) 2017, patient had bilateral knee effusions, both knees were swollen, was having pain and difficulty ambulating.Right knee pain was worse than left knee pain.Patient was interested in having a right knee replacement, but not until february.Patient has been taking mobic 15mg once a day.On the same day, the patient was prepped aseptically with povidone iodine swabsticks.30cc's of cloudy joint fluid was aspirated from the superolateral aspect of the right and left knee joint using a 18g x 1.5 needle in sterile fashion without complication.Following aspiration, a diagnostic and therapeutic injection of 1 :3cc kenalog/marcaine was given under sterile technique in the supine position.Patient reported decreased pain and swelling following the injections.On the same day, outpatient cultures were sent off from bilateral knee aspirations which were negative.On (b)(6) 2017, one lot of synvisc one was voluntary recalled due to an ongoing investigation which revealed the presence of microbial, methylobacterium thiocyanatum, and alpha proteobacterial class, aerobic, gram negative rod.It was possible that the patient received an injection from the recalled lot.On (b)(6) 2017, patient again visited for follow up of both knees.Patient was doing well since the steroid injection administered on (b)(6) 2017.Patient's pain on pain scale was 6 over the past 3 days.On the same day, patient was diagnosed with traumatic arthritis of right knee- primary.Patient was recommended right knee total knee replacement.On (b)(6) 2017, patient had a computerized tomography (ct) of right knee and the findings were degenerative changes are seen involving the right knee comment lateral greater than medial compartments.Additional patellofemorai djd.Partially visualized intrapelvic contents were unremarkable.No evidence of soft tissue mass or fluid collections within the visualized right lower extremity.No evidence of osseous destructive process or fracture.No acute abnormalities in this examination were obtained for preoperative planning.On an unknown date, patient had a bruise that developed around the injection site (size of a dime), but no torn or damaged skin which resolved.It was a scaly dry patch where the bruising and injection sight was.Larger area on the left knee, then the right.On an unknown date in (b)(6) 2018, patient developed a skin discoloration (black, scaly discolorization) at the injection site.It was reported that skin discoloration happens sometimes after a knee is drained.On (b)(6) 2018, patient had complaints of right and medial knee pain.On (b)(6) 2018, patient had chronic pain of right knee.On 10-jan-2018, patient visited again for left and right knee pain and primary discoloration of skin around aspiration sites in bilateral knees.As of (b)(6) 2018, patient's pain on pain scale was 7 over the past 3 days.On (b)(6) 2018, patient was given pain management regime: oxycodone hydrochloride, paracetamol (percocet) 10/325 mg (1 df, oral, q 4-6 hours prn), tramadol hydrochloride (ultram) 50 mg (1df, p.O.Q.4-6 hours p.R.N, acetylsalicylic acid (aspirin) 325 mg (oral daily), celecoxib (celebrex).On (b)(6) 2018, patient had right knee pain and had total right knee replacement.It was reported that patient's preoperative diagnosis was right arthritis, traumatic, degenerative joint disease (djd) knee and genu varum (acquired).On (b)(6) 2018, patient had primary localized osteoarthrosis of right lower leg.On (b)(6) 2018, patient was prescribed outpatient physical therapy and was provided a copy of exercises to perform as tolerated at home (qs towel roil 10 sec x 10, prone knee flex strap 2 min b, prone hang 3 min, sir 15x and laq 15x).On the same day, patient's pain and swelling had increased as ice machine broke, and pain was 5 in right knee on pain scale.Also, patient's leg was tightened up again.It was reported that the patient had received individual therapeutic exercises to develop strength, endurance, rom, flexibility, posture and core stabilization for 65 minutes.Patient tolerated the treatment well without adverse reaction.On (b)(6) 2018, patient had decreased ambulation status, weakness of right leg, decreased range of motion (rom) of right knee and lot of pain in knee.Patient rated pain at r knee on a scale of 0-10 to be 5 currently.As of(b)(6) 2018, it was reported that discomfort that patient was having was not pain, but muscle spasms.When patient turned, moved or cough the muscles in back of knee and upper thigh hurts horribly.On (b)(6) 2018, patient had derangement of collateral ligament of right knee.On the same day, patient's right knee examination showed scars, effusion (small joint effusion noted in radiogarph) and deformity; left knee examination showed scars and deformity.Patient continued with right leg muscles spasms in medial and posterior region of knee and rated pain at r knee on a scale of 0-10 to be 5 currently.On (b)(6) 2018, patient visited again for right knee post operation evaluation and was diagnosed with chronic pain of left knee and plantar fasciitis, bilateral.Patient was also diagnosed with right arthritis, traumatic, djd knee and genu varum (acquired).On the same day, patient's knee radiographs showed postoperative changes identified relating to a prior right knee arthroplasty procedure.Prostheses appeared unremarkable.On the left, there was tibiofemoral joint space narrowing and spurring again seen, as well as minimal superior patellar spurring.Osseous structures demonstrate no evidence of recent or healing fracture, lytic destructive process, development of abnormal periprosthetic lucency, or other significant detrimental interval change since the examinations referenced above.Some minor soft tissue fullness in the suprapatellar bursa on the right side was consistent with a joint effusion, decreased in volume since (b)(6) 2018.No joint effusion on the left.On the same day, patient was again aspirated and a diagnostic and therapeutic injection of 2:5cc kenalog/marcaine was given under sterile technique in the supine position.Patient had no adverse reactions to the medication.Pain decreased.Patient was instructed to apply ice to the joint for 20 minutes and avoid strenuous activities for 24-36 hours following the injection.Patient was also trained for custom orthotic/brace adjustment and fitting and visco heel cups.Patient was also given meloxicam.On (b)(6) 2018, patient's pain on pain scale was 0, on (b)(6) 2018: 3.As of (b)(6) 2018, patient's range of motion continued to improve, was told to use cane more and continued to benefit from skilled physical therapy.On (b)(6) 2018, patient's portable frontal and lateral views of the right knee were obtained, and finding was there was postsurgical change consistent with right knee total arthroplasty.Alignment was satisfactory.Postsurgical drains and soft tissue were present.It was reported that post right knee total arthroplasty was with satisfactory alignment.Patient rated pain on pain scale 9 at worst; 5 currently; 0 at best.Right knee pain aggravated with weight bearing and eased with ice and pain medication.Also range of motion in right knee was 70-degree flexion and -10 degrees extension, hypomobile joint, palpation: tenderness at patella and joint line and sensation: intact to light touch.Edema in right knee was visible.Patient displayed unsteady gait, decreased step length, increased base of support, hip hiking and antalgic gait.Patient received 15 minutes of therapeutic exercise including home exercise.Patient tolerated evaluation well.Patient reported no increases in symptoms on the same day and felt comfortable with home exercises.Patient required a wheel chair to get to her car after her visit because the pain was too much to walk.On (b)(6) 2018, patient had difficulty sleeping because she did not take her pain medication.As of (b)(6) 2018 pain at r knee on a scale of 0-10 was 3 currently.Patient was treated with meloxicam (mobic), bupivacaine hydrochloride (marcaine), percocet, ultram, aspirin, celecoxib and triamcinolone acetonide (kenalog), for knee pain/left and right knee pain/chronic pain of left knee; meloxicam, bupivacaine hydrochloride and triamcinolone acetonide for both knees were swollen, bupivacaine hydrochloride and triamcinolone acetonide for bilateral knee effusions, both knees were swollen, traumatic arthritis of right knee- primary, derangement of collateral ligament of right knee and decreased range of motion of right knee; not reported for other events.Outcome: recovering for knee pain/left and right knee pain/chronic pain of left knee and both knees were swollen, not recovered for difficulty ambulating/decreased ambulation status, decreased range of motion of right knee, derangement of collateral ligament of right knee and primary localized osteoarthrosis of right lower leg, recovered for bruise that developed around the injection site (size of a dime), unknown for other events a product technical complaint was initiated on (b)(6) 2018 for synvisc-one.Batch number: unknown global ptc number:(b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa is required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: required intervention for derangement of collateral ligament of right knee, decreased range of motion of right knee, knee pain/left and right knee pain/chronic pain of left knee and both knees were swollen, bilateral knee effusions and traumatic arthritis of right knee- primary additional information was received on 02-oct-2018 from a lawyer.Information about patient's clinical condition was added after total right knee replacement.Corrective treatment for arthralgia was updated.Event term both knees were swollen was updated to both knees were swollen/edema, skin discoloration at the injection site was updated to skin discoloration at the injection site/black, scaly discolorization.Clinical course was updated, and text was amended accordingly.Additional information received on 12-oct-2018.Investigation summary received, and ptc results added.Clinical course updated.Text amended accordingly.
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