| Lot Number 7RSL021 |
| Device Problem
Microbial Contamination of Device (2303)
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| Patient Problems
Aspiration/Inhalation (1725); Erythema (1840); Fatigue (1849); Synovitis (2094); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment dated (b)(6) 2018: this case concerns a patient who was on treatment with synvisc one and later it a device malfunction was noted for reported batch number.The relationship of the event with suspect cannot be denied.However, further information regarding patient¿s current clinical presentation, onset latencies and other risk factors will aid in the complete medical case assessment.
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Event Description
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Device malfunction [device malfunction] ; 35cc blood tinged fluid aspirated [joint effusion] ; swelling [swelling of l knee] ; left knee pain/joint pain/medial patellar facet/lateral patellar facet tender [knee pain] ([condition aggravated]).Case narrative: initial information received from united states on (b)(6) 2018 regarding an unsolicited valid serious malfunction case received from physician.This case involves (b)(6) male patient who experienced 35cc blood tinged fluid aspirated, swelling and left knee pain/joint pain/medial patellar facet/lateral patellar facet tender (latency: unknown), while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Also device malfunction was identified for the reported lot number.The patient's past medical history included right elbow surgery in (b)(6) 1997, (b)(6) 1998 and (b)(6) 1999, staph infection in 1999, surgery staph infection surgery left leg achilles tendon surgery in (b)(6) 1999, deviated septum repaired in (b)(6) 2007, right hamstring repair in (b)(6) 2013, exploration of right sciatic nerve, revision right hamstring repair, removal of heterotopic ossification and sciatic neurolysis on (b)(6) 2016, right arthroscopic acetabuloplasty, notchplasty, labral repair, ligamentum teres debridement, iliopsoas bursectomy, femoroplasty and capsular plication on (b)(6) 2017, diverticulitis, sleep apnea, anxiety, depression, and diphenhydramine hydrochloride (benadryl) allergy.Patient was a former smoker.The patient reports a family history of: anxiety: sibling; cancer: sibling, other, father; diabetes type 1: father, other; depression: sibling; high blood pressure: sibling, mother, father; seizures: other, father.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, he continues to experience anterior, lateral and subpatellar pain.Concomitant medications included temazepam; gabapentin; acetylsalicylic acid (aspirin); oxycodone hydrochloride (roxicodone) for pain; paracetamol (tylenol extra-strength); atorvastatin calcium; sertraline hydrochloride (zoloft); clonazepam; bupropion hydrochloride (buproban); orphenadrine citrate; levothyroxine sodium (l-thyroxine); paracetamol (tylenol); and hydrocodone bitartrate, paracetamol (norco) for pain.Patient also complained of hip pain.On (b)(6) 2017, left knee exam revealed flexion was 135, patient was well-nourished and well-developed, white sclera, teeth and gums were normal, breathing was easy, skin normal over the affected area, normal sensation and pulses distally.On the same day, at 10:02 am, the patient started using hylan g-f 20, sodium hyaluronate injection in the left knee, at dose of 6 cc, intra-articular (lot - 7rsl021, expiration date: may-2020) for knee pain, arthritis and/or intraarticular derangement.The left knee was visualized under ultrasound from a supero-lateral approach.Under sterile conditions, a 22-gauge needle was inserted under ultrasound guidance into the knee.The synvisc injection was distributed throughout the knee.Care was taken to avoid the cartilage surfaces.Ultrasound imagery of the injection site was obtained, and appropriate images were labeled, saved and permanently archived.No complication was experienced.Assessment showed left knee pain in the setting of chondromalacia patella and osteoarthritis.On (b)(6) 2018, patient had left knee open patella femoral unicompartmental arthroplasty with robotic assistance.On an unknown date, patient had knee pain (latency: unknown).On (b)(6) 2018, patient had an increase in left knee pain and swelling (latency: unknown).On (b)(6) 2018, it was reported that left knee pain decreased from previous exam.The patient complains of dull pain about the anterior aspect.The patient describes the pain as being a 6 out of 10 on a 10 point pain scale.He has been compliant with post-operative activity restrictions.(b)(6) continues to take narcotics for pain control.He denies fevers, chills, sweats, numbness, tingling and electric shocks.General review of system was normal except musculoskeletal which showed joint pain (latency: unknown).It was reported that incision was healed.Also, on the same day, physical examination showed tender medial patellar facet and lateral patellar facet (latency: unknown).On the same day, 35 cc blood tinged fluid was aspirated.Final diagnosis was left knee pain/joint pain/medial patellar facet/lateral patellar facet tender, swelling, 35cc blood tinged fluid aspirated and device malfunction.Corrective: paracetamol (tylenol) for left knee pain/joint pain/medial patellar facet/lateral patellar facet tender, swelling; not reported for rest of the events outcome: unknown for all events seriousness criteria: medically significant for device malfunction 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.
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Event Description
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Device malfunction [device malfunction] many white blood cells/neutrophils/monocytes left knee synovial fluid [synovial fluid white blood cells positive] red blood cells left knee synovial fluid [synovial fluid red blood cells positive] bear weight with difficulty [weight bearing difficulty] weakness [weakness] instability/sense of giving out [joint instability] redness [redness] catching [joint lock] electric shock [electric shock sensation] popping/grinding [joint clicking] swelling [swelling of l knee] palpable warmth [injection site joint warmth] 35cc blood tinged fluid aspirated/large 2+ effusion [joint effusion] left knee pain/joint pain/medial patellar facet/lateral patellar facet tender/sudden surge in pain [knee pain] ([condition aggravated]) case narrative: initial information received from united states on 13-sep-2018 regarding an unsolicited valid serious malfunction case received from physician.This case involves 49 year old male patient who experienced 35cc blood tinged fluid aspirated/large 2+ effusion left knee pain/joint pain/medial patellar facet/lateral patellar facet tender/sudden surge in pain (latency: 0 day), many white blood cells/neutrophils/monocytes left knee synovial fluid, red blood cells left knee synovial fluid (latency: 1 day), bear weight with difficulty, weakness, redness, catching, popping/grinding, electric shock, palpable warmth, swelling, instability/sense of giving out (latency: unknown) while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Also, device malfunction was identified for the reported lot number.The patient's past medical history included right elbow surgery in jun-1997, jun-1998 and jun-1999, staph infection in 1999, surgery staph infection surgery left leg achilles tendon surgery in jun-1999, deviated septum repaired in jun-2007, right hamstring repair in (b)(6) 2013, exploration of right sciatic nerve, revision right hamstring repair, removal of heterotopic ossification and sciatic neurolysis on (b)(6) 2016, right arthroscopic acetabuloplasty, notchplasty, labral repair, ligamentum teres debridement, iliopaoas bursectomy, femoroplasty and capsular plication on (b)(6) 2017, right hip arthroscopy, diverticulitis, sleep apnea, anxiety, depression, and diphenhydramine hydrochloride (benadryl) allergy.Patient was a former smoker.The patient reports a family history of: anxiety: sibling; cancer: sibling, other, father; diabetes type 1: father, other; depression: sibling; high blood pressure: sibling, mother, father; seizures: other, father.Patient also complained of hip pain and joint pain, mild arthritis under kneecap, medial knee pain bilaterally.Left knee radiographs from (b)(6) 2017 showed small baker's cyst and patient had ultrasound guided lidocaine hydrochloride, methylprednisolone acetate (depo-medrol) injection in left knee.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, he continues to experience anterior, lateral and subpatellar pain.Concomitant medications included temazepam; gabapentin; acetylsalicylic acid (aspirin); oxycodone hydrochloride (roxicodone) for pain; paracetamol (tylenol extra-strength); atorvastatin calcium; sertraline hydrochloride (zoloft); clonazepam; bupropion hydrochloride (buproban); orphenadrine citrate; levothyroxine sodium (l-thyroxine); paracetamol (tylenol); and hydrocodone bitartrate, paracetamol (norco) for pain.On (b)(6) 2017, left knee exam revealed flexion was 135, patient was well-nourished and well-developed, white sclera, teeth and gums were normal, breathing was easy, skin normal over the affected area, normal sensation and pulses distally.On the same day, at 10:02 am, the patient started using hylan g-f 20, sodium hyaluronate injection in the left knee, at dose of 6 cc, intra-articular (lot - 7rsl021, expiration date: may-2020) for knee pain, arthritis and/or intraarticular derangement.The left knee was visualized under ultrasound from a supero-lateral approach.Under sterile conditions, a 22-gauge needle was inserted under ultrasound guidance into the knee.The synvisc injection was distributed throughout the knee.Care was taken to avoid the cartilage surfaces.Ultrasound imagery of the injection site was obtained, and appropriate images were labeled, saved and permanently archived.No complication was experienced.Assessment showed left knee pain in the setting of chondromalacia patella and osteoarthritis.On the same day, patient had sudden surge in pain and effusion approximately 4 hours after the injection.On (b)(6) 2017, pain was 10/10, localized to the anterior and posterior knee.Patient had large 2+ effusion, palpable warmth, no erythema, pain to palpation throughout joint.Left knee aspiration was carried out with 16 g needle and 75cc of clear, yellow fluid was removed.The knee was cleansed and a bandage was applied.Patient tolerated procedure well.3 cc of fluid was sent for review to lab.Patient was asked to follow up in two weeks for cortisone injection if lab values showed evidence of infection.The synovial fluid analysis from left knee showed 35360 /microl white blood cells, 86% neutrophils, 14 monocytes and gram stain report showed no organism growth and many white blood cells.On (b)(6) 2017, patient complained of sharp knee pain, 3 out of 10 on 10 point pain scale (duration: approximately 6 months).Patient reported night pain which was constant and symptoms occur during the entire day and activity.Patient did not experience fall, sports injury.Patient reported instability and sense of giving out, able to bear weight with difficulty, mechanical symptoms including catching, weakness, swelling, redness, joint pain, electric shocks, popping, grinding.The pain was exacerbated by movement, going up stairs or downstairs, walking, standing and bending.Alleviating factors was resting.Patient was recommended conservative management (rest, activity modification, ice etc.) and if that did not work patient would be candidate for partial knee replacement of the patellofemoral joint.On (b)(6) 2018, patient had left knee open patella femoral unicompartmental arthroplasty with robotic assistance.On an unknown date, patient had knee pain (latency: unknown).On (b)(6) 2018, patient had an increase in left knee pain and swelling (latency: unknown).On (b)(6) 2018, it was reported that left knee pain decreased from previous exam.The patient complains of dull pain about the anterior aspect.The patient describes the pain as being a 6 out of 10 on a 10 point pain scale.He has been compliant with post-operative activity restrictions.Paul continues to take narcotics for pain control.He denies fevers, chills, sweats, numbness, tingling and electric shocks.General review of system was normal except musculoskeletal which showed joint pain (latency: unknown).It was reported that incision was healed.Also, on the same day, physical examination showed tender medial patellar facet and lateral patellar facet (latency: unknown).On the same day, 35 cc blood tinged fluid was aspirated.Final diagnosis was left knee pain/joint pain/medial patellar facet/lateral patellar facet tender, swelling, 35cc blood tinged fluid aspirated and device malfunction.Corrective: paracetamol (tylenol) for left knee pain/joint pain/medial patellar facet/lateral patellar facet tender/sudden surge in pain, swelling; not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: medically significant for device malfunction.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 25-sep-2018.No new information was received.Additional information was received on 20-nov-2018 from lawyer.Event of instability/sense of giving out, many white blood cells/neutrophils/monocytes left knee synovial fluid, red blood cells left knee synovial fluid, bear weight with difficulty, weakness, redness, catching, popping/grinding, electric shock, palpable warmth were added with details.Lab data dated 16-nov-2018 was added.Verbatim of event left knee pain/joint pain/medial patellar facet/lateral patellar facet tender was updated to left knee pain/joint pain/medial patellar facet/lateral patellar facet tender/sudden surge in pain, 35cc blood tinged fluid aspirated was updated to 35cc blood tinged fluid aspirated/large 2+ effusion and start date was also updated for both the events.Start date for swelling was updated.
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Event Description
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Device malfunction [device malfunction] dysfunction of the knee [joint dysfunction] synovitis [synovitis] ([joint effusion], [knee pain], [swelling of l knee], [condition aggravated], [synovial fluid white blood cells positive]) red blood cells left knee synovial fluid [synovial fluid red blood cells positive] bear weight with difficulty [weight bearing difficulty] weakness [weakness] instability/sense of giving out [joint instability] redness [redness] catching [joint lock] popping/grinding [joint clicking] electric shock [electric shock sensation] palpable warmth [injection site joint warmth] case narrative: initial information received from united states on 13-sep-2018 regarding an unsolicited valid legal serious malfunction case received from physician.This case involves 49-year-old male patient who experienced red blood cells left knee synovial fluid (latency: 1 day), bear weight with difficulty, weakness, redness, catching, popping/grinding, electric shock, palpable warmth, instability/sense of giving out, synovitis (latency: unknown) while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Also, device malfunction was identified for the reported lot number.The patient's past medical history included right shoulder reconstruction in 1990, bilateral knee arthroscopy in 1990, right elbow surgery in jun-1997, jun-1998 and jun-1999, achilles tendon removed in 1998, staph infection in 1999, surgery staph infection surgery left leg achilles tendon surgery in jun-1999, deviated septum repaired in jun-2007, right hamstring repair in (b)(6) 2013, right hamstring muscle rupture in (b)(6) 2013, right proximal hamstring tendon rupture in sep-2013, rotator cuff syndrome of left shoulder, stiffness of joint, shoulder joint, testicular hypofunction, ptsd, depressive disorder, right rotator cuff surgery in 2012, left rotator cuff surgery in 2013, hamstring attachment in 2013, exploration of right sciatic nerve, revision right hamstring repair, removal of heterotopic ossification and sciatic neurolysis on (b)(6) 2016, right arthroscopic acetabuloplasty, notchplasty, labral repair, ligamentum teres debridement, iliopaoas bursectomy, femoroplasty and capsular plication on (b)(6) 2017, right hip arthroscopy, diverticulitis, sleep apnea, anxiety, depression, and diphenhydramine hydrochloride (benadryl) allergy.Patient was a former smoker.The patient reports a family history of: anxiety: sibling; cancer: sibling, other, father; diabetes type 1: father, other; depression: sibling; high blood pressure: sibling, mother, father; seizures: other, father.Patient also complained of hip pain and joint pain, mild arthritis under kneecap, medial knee pain bilaterally.Left knee radiographs from (b)(6) 2017 showed small baker's cyst and patient had ultrasound guided lidocaine hydrochloride, methylprednisolone acetate (depo-medrol) injection in left knee.Patient also had concurrent condition of foley catheter.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, he continues to experience anterior, lateral and subpatellar pain.Concomitant medications included temazepam; gabapentin; acetylsalicylic acid (aspirin); oxycodone hydrochloride (roxicodone) for pain; paracetamol (tylenol extra-strength); atorvastatin calcium; sertraline hydrochloride (zoloft); clonazepam; bupropion hydrochloride (buproban); orphenadrine citrate; levothyroxine sodium (l-thyroxine); paracetamol (tylenol); and hydrocodone bitartrate, paracetamol (norco) for pain; hyoscine (scoplolamine); cefazolin sodium; azelastine hcl; diazepam; morphine sulphate; zolpidem tartrate (ambien); cyclobenzaprine hydrochloride (flexeril); sennoside a+b (senokot); docusate sodium (colace); macrogol 3350 (miralex); milk of magnesia; bisacodyl (dulcolax); metoclopramide hydrochloride (reglan) and apixaban (eliquis).On (b)(6) 2017, left knee exam revealed flexion was 135, patient was well-nourished and well-developed, white sclera, teeth and gums were normal, breathing was easy, skin normal over the affected area, normal sensation and pulses distally.On the same day, at 10:02 am, the patient started using hylan g-f 20, sodium hyaluronate injection in the left knee, at dose of 6 cc, intra-articular (lot - 7rsl021, expiration date: may-2020) for knee pain, arthritis and/or intraarticular derangement.The left knee was visualized under ultrasound from a supero-lateral approach.Under sterile conditions, a 22-gauge needle was inserted under ultrasound guidance into the knee.The synvisc injection was distributed throughout the knee.Care was taken to avoid the cartilage surfaces.Ultrasound imagery of the injection site was obtained, and appropriate images were labeled, saved and permanently archived.No complication was experienced.Assessment showed left knee pain in the setting of chondromalacia patella and osteoarthritis.On the same day, patient had sudden surge in pain and effusion approximately 4 hours after the injection.On (b)(6) 2017, pain was 10/10, localized to the anterior and posterior knee.Patient had large 2+ effusion, palpable warmth, no erythema, pain to palpation throughout joint.Left knee aspiration was carried out with 16 g needle and 75cc of clear, yellow fluid was removed.The knee was cleansed and a bandage was applied.Patient tolerated procedure well.3 cc of fluid was sent for review to lab.Patient was asked to follow up in two weeks for cortisone injection if lab values showed evidence of infection.The synovial fluid analysis from left knee showed 35360 /microl white blood cells, 86% neutrophils, 14 monocytes and gram stain report showed no organism growth and many white blood cells.On (b)(6) 2017, patient complained of sharp knee pain, 3 out of 10 on 10 point pain scale (duration: approximately 6 months).Patient reported night pain which was constant and symptoms occur during the entire day and activity.Patient did not experience fall, sports injury.Patient reported instability and sense of giving out, able to bear weight with difficulty, mechanical symptoms including catching, weakness, swelling, redness, joint pain, electric shocks, popping, grinding.The pain was exacerbated by movement, going up stairs or downstairs, walking, standing and bending.Alleviating factors was resting.Patient was recommended conservative management (rest, activity modification, ice etc.) and if that did not work patient would be candidate for partial knee replacement of the patellofemoral joint.On(b)(6) 2018, patient had left knee open patella femoral unicompartmental arthroplasty with robotic assistance.On an unknown date, patient had knee pain (latency: unknown).On (b)(6) 2018, patient had an increase in left knee pain and swelling (latency: unknown).On (b)(6) 2018, it was reported that left knee pain decreased from previous exam.The patient complains of dull pain about the anterior aspect.The patient describes the pain as being a 6 out of 10 on a 10 point pain scale.He has been compliant with post-operative activity restrictions.Paul continues to take narcotics for pain control.He denies fevers, chills, sweats, numbness, tingling and electric shocks.General review of system was normal except musculoskeletal which showed joint pain (latency: unknown).It was reported that incision was healed.Also, on the same day, physical examination showed tender medial patellar facet and lateral patellar facet (latency: unknown).On the same day, 35 cc blood tinged fluid was aspirated.On (b)(6) 2019, patient visited to healthcare facility, it was reported that patient had the history of patellofemoral arthroplasty over a year ago.He was continued to have significant pain, swelling and dysfunction of the knee.He had multiple conservative treatment options including physical therapy, pain medications activity modification.He had multiple negative aspirations for infection.He had diagnostic arthroscopy done which was unremarkable.Patient continued to have pain in his knee and required cane to walk.Preoperative diagnosis was failed patellofemoral arthroplasty.On the same day, when patient underwent for left total knee arthroplasty and during that procedure it was observed that patient had large joint effusion with synovitis throughout the knee.On (b)(6) 2019, it was observed that during synovial fluid analysis that 2+ wbc was seen in the fluid and no organism seen in the synvial fluid culture.On(b)(6) 2019, when lab analysis was done it was observed that red blood cell count was 4.06 m/ul, hemoglobin was 12.0 g/dl and hematocrit was 36.2 %.The same day, patient was complaining of pain, stated his pain was an 8-9 out of 10.Complete left knee arthroplasty was in satisfactory alignment and position.No gross evidence of loosening.Corrective: paracetamol (tylenol) for left knee pain/joint pain/medial patellar facet/lateral patellar facet tender/sudden surge in pain, swelling; not reported for rest of the events.Outcome: unknown for all of the events.Seriousness criteria: disability and intervention required for dysfunction of the knee, synovitis; medically significant for device malfunction.Product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc one; batch number: 7rsl021, local ptc number: (b0(4); 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 25-sep-2018.No new information was received.Additional information was received on 20-nov-2018 from lawyer.Event of instability/sense of giving out, many white blood cells/neutrophils/monocytes left knee synovial fluid, red blood cells left knee synovial fluid, bear weight with difficulty, weakness, redness, catching, popping/grinding, electric shock, palpable warmth were added with details.Lab data dated (b)(6) 2018 was added.Verbatim of event left knee pain/joint pain/medial patellar facet/lateral patellar facet tender was updated to left knee pain/joint pain/medial patellar facet/lateral patellar facet tender/sudden surge in pain, 35cc blood tinged fluid aspirated was updated to 35cc blood tinged fluid aspirated/large 2+ effusion and start date was also updated for both the events.Start date for swelling was updated.Follow-up was received on 08-oct-2018.Global ptc number added.No significant information was received.Additional information was received on 14-mar-2019 from the lawyer.Events of synovitis and dysfunction of the knee were added.Events of swelling, 5cc blood tinged fluid aspirated/large 2+ effusion/ develop effusions/large joint effusion, left knee pain/joint pain/medial patellar facet/lateral patellar facet tender/sudden surge in pain/ pain in his knee and many white blood cells/neutrophils/monocytes left knee synovial fluid were upgraded as symptoms to synovitis.Medical history was updated.Concomitant medications were updated.Clinical course updated, and text amended accordingly.
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