|
Device malfunction [device malfunction].Large joint arthrocenthesis [joint effusion].Case narrative: initial information received on 02-oct-2018 from united states regarding an unsolicited valid legal serious case received from a consumer.This case involves a (b)(6) female patient (b)(6) who experienced large joint arthrocentesis, while she was treated with hylan g-f 20, sodium hyaluronate [synvisc one].Additionally, event of device malfunction was added.The patient's past medical history included hypertension and hysterectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient was a nonsmoker and had social alcohol use.At the time of the event, the patient had ongoing chronic bronchitis, primary osteoarthritis of both knees and bilateral knee pain concomitant medications included codeine phosphate, guaifenesin (cheratussin ac); and lisinopril (lisinopril).On (b)(6) 2017, the patient received intra-articular injection of synvisc one (hylan g-f 20, sodium hyaluronate) in both knees at dosage 6 ml 1x (batch number: 7rsl021 exp may-2020) for joint pain and osteoarthritis.Alcohol was used to prep the area; ethyl chloride spray was used as a topical anesthetic.An 18-gauge syringe was used to inject 6ml of synvisc-one in both knees.The injections were provided to the knees while they were in extension cross-table technique right knee left knee medial suprapatellar approach.The patient tolerated the procedure well.No complications were noted.On (b)(6) 2018, patient underwent large joint arthrocentesis (latency: 4 months 20 days) in right knee.Patient was prepped and draped in usual sterile fashion.A 22-gauge needle was used; 2ml bupivacaine 0.25%; 2ml lidocaine 1%; 12mg betamethasone acetate-betamethasone sodium phosphate (3-3) mg/ml were administered.Patient tolerated the procedure well with no immediate complications; sterile dressing was applied.Outcome: unknown.Seriousness criterion: medically significant and required intervention for device malfunction, required intervention for large joint arthrocenthesis an investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from 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.
|
|
Device malfunction [device malfunction] large joint arthrocenthesis/effusion/reactions with efffusions [joint effusion] arthralgia both knees/pain/arthritic pain [arthralgia] significant tenderness to palpation [tenderness] pain with flexion beyond 90 degree [pain upon movement] warm sensate extremity distally [sensation of warmth] medial greater than lateral compartment discomfort to palpation/fullness in the bilateral suprapatellar pouches/popliteal fullness in the left knee [discomfort in joints] 60 cc of cloudy yellowish orange fluid right knee/90 cc cloudy yellowish fluid left knee [synovial fluid analysis abnormal] increased difficulty with weight-bearing [weight bearing difficulty] difficulty ambulating [walking difficulty] decreased ability to bend her knee/difficulty with the range of motion [joint range of motion decreased] stiffness in the a.M.[early morning joint stiffness] increase in swelling/posterior left knee swelling [swelling of l knee].Case narrative: initial information received on 02-oct-2018 from united states regarding an unsolicited valid legal serious case received from a consumer.This case involves a 66 years old female patient who experienced both knees/pain/arthritic pain, increase in swelling/posterior left knee swelling, difficulty ambulating (latency: 0 day), large joint arthrocentesis, arthralgia decreased ability to bend her knee/difficulty with the range of motion, significant tenderness to palpation, pain with flexion beyond 90 degree, warm sensate extremity distally, stiffness in the a.M., increased difficulty with weight-bearing, medial greater than lateral compartment discomfort to palpation/fullness in the bilateral suprapatellar pouches/popliteal fullness in the left kne (latency: unknown), 60 cc of cloudy yellowish orange fluid right knee/90 cc cloudy yellowish fluid left knee (latency: 2 days), while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).A device malfunction was noted in the reported batch number the patient's past medical history included hypertension and hysterectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient was a nonsmoker and had social alcohol use.At the time of the event, the patient had ongoing chronic bronchitis, congestion, primary osteoarthritis of both knees and bilateral knee pain.Concomitant medications included codeine phosphate, guaifenesin (cheratussin ac); and lisinopril (lisinopril).On(b)(6) 2017, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate in both knees at dosage 6 ml 1x (batch number: 7rsl021 exp may-2020) for joint pain and primary osteoarthritis of both knees.Alcohol was used to prep the area; ethyl chloride spray was used as a topical anesthetic.An 18-gauge syringe was used to inject 6ml of hylan g-f 20, sodium hyaluronate in both knees.The injections were provided to the knees while they were in extension cross-table table technique right knee left knee medial suprapatellar approach.The patient tolerated the procedure well.No complications were noted.Patient reported that since that time patient had increase in swelling and difficulty ambulating (latency: 0 day).Patient had decreased ability to bend the knee, left knee had posterior knee swelling (latency: unknown).Patient had fullness in the bilateral suprapatellar pouches, significant tenderness to palpation, pain with flexion beyond 90 degree, warm sensate extremity distally, popliteal fullness in the left knee (latency: unknown).On (b)(6) 2017, patient was aspirated and 60 cc of cloudy yellowish orange fluid from right knee and 90 cc cloudy yellowish fluid from left knee was aspirated (latency: 2 days).Patient continues to have arthritic pain such as stiffness in the a.M, difficulty with range of motion, increased difficulty with weight bearing (latency: unknown).Patient wishes to pursue non-operative treatment.On (b)(6) 2018, physical examination showed medial greater than lateral compartment discomfort to palpation and patient had steroid injection the same day for joint pain and osteoarthritis.Also, the same day patient reported to be over 4 weeks from the event and there was no re-occurrence of effusions of either knee.On (b)(6) 2018, patient underwent large joint arthrocentesis in right knee.Patient was prepped and draped in usual sterile fashion.A 22-gauge needle was used; 2ml bupivacaine 0.25%; 2ml lidocaine 1%; 12mg betamethasone acetate-betamethasone sodium phosphate (3-3) mg/ml were administered.Patient tolerated the procedure well with no immediate complications; sterile dressing was applied.Corrective treatment: vicodin, arthrocentesis, betamethasone for arthralgia both knees/pain/arthritic pain, large joint arthrocenthesis for large joint arthrocenthesis/effusion/reactions with effusions; not reported for rest of the events outcome: not recovered for arthralgia both knees/pain/arthritic pain, unknown for rest of the events seriousness criterion: required intervention for large joint arthrocenthesis/effusion/reactions with efffusions and arthralgia both knees/pain/arthritic pain, device malfunction a product technical complaint was initiated on (b)(6) 2018 for synvisc-one.Batch number: 7rsl021 global ptc number: (b)(4).An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from 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 received on 12-oct-2018.Global ptc number added.Additional information was received on 19-feb-2019 from lawyer.Concurrent condition were updated.Events of arthralgia both knees/pain/arthritic pain, increase in swelling/posterior left knee swelling, difficulty ambulating, decreased ability to bend her knee/difficulty with the range of motion, significant tenderness to palpation, pain with flexion beyond 90 degree, warm sensate extremity distally, 60 cc of cloudy yellowish orange fluid right knee/90 cc cloudy yellowish fluid left knee, stiffness in the a.M., increased difficulty with weight-bearing, medial greater than lateral compartment discomfort to palpation/fullness in the bilateral suprapatellar pouches/popliteal fullness in the left knee were added with details.Seriousness criteria was updated.Clinical course updated.Text amended accordingly.
|
