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Device malfunction [device malfunction].Limping [limping].Reaction to the injection/ inflammation [joint inflammation] ([knee swelling], [knee pain], [joint warmth], [joint effusion], [knee lock]).Clostridium difficile [clostridium difficile infection] ([stomach discomfort], [arthralgia], [groin pain], [back pain], [hip discomfort]).Reduce hip mobility/ hips lock up when getting out of chair [joint range of motion decreased].Case narrative: initial information received from united states on 19-jun-2018 regarding an unsolicited valid serious case received from other non-health care professional.This case involves a (b)(6) years old male patient who experienced limping, reaction to the injection/ inflammation (latency: 3 hours), clostridium difficile (latency: unknown) while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one); also, device malfunction was identified for the reported lot number.Medical history included medial meniscus tear of the right knee and right knee surgery (prior to the synvisc-one injections).Past medical treatment included synvisc one with four or five synvisc-one injections in the right knee (last injection in (b)(6) 2015; every 6 months getting the injections).The patient's past vaccination(s) and family history were not provided.Patient had no history of prosthetic device and allergy history to avian proteins, feathers, or egg products.Patient was able to bear the weight before injection.On (b)(6) 2017, the patient started taking intra-articular hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml once (lot - 7rsl021) for unknown indication in the right knee.Patient had to walk home and after a while he started limping.Patient got home that same day, elevated his right knee, three hours later, experienced right knee swelling through his pants and knee pain.Patient took off his pants, his right knee was swelling there was pain in the right knee.On the scale of 1-10, the patient had pain of 10.The knee was hot to the touch.Patient wrapped the right knee in ice packs and kept it on for a couple of hours.His wife brought him some crutches he had.Patient used crutches to get around for a week and then a cane for three weeks.Patient was not able to bear the weight before injection.Patient emailed his physician that day on the next morning, he could not remember about his symptoms.The physician said he might have a reaction to the injection.The physician prescribed celebrex for the pain and inflammation.The knee was almost three times its normal size.The physician aspirated the knee and gave prednisone when celebrex did not work.It took about a month to get the swelling completely down and not have any pain.It was reported that the blood and/or knee sample cultures were performed.Also reported, after injected with the synvisc-one patient started to have some stomach problems and in (b)(6) 2018 patient was diagnosed with c-diff.He said he was being treated for the clostridium difficile.Patient still had the stomach issues.Patient said, during the time of his right knee swelling and pain, he started experiencing piercing and stabbing pain issues with both hips and both side of his groin.He said the left side of his hip was the worse and was feeling the pain externally of the hips and the inside of the groin.He said his hip joints feel like they would lock and he would have pain.On (b)(6) 2018, the patient reported his right knee locked after having a few days of knee pain.Patient had reduced hip mobility, hip pain and his hips locked up when getting out of chair or a car.He said if he twist his hips, he would get a stabbing pain inside his groin area.The physician put him on another anti-inflammatory medication called: nabumetone (by impax) 750 mg twice a day to treat the pain on (b)(6) 2018.Patient felt that hips felt disconnected, had lower back pain and it was very tender.Final diagnosis was reaction to the injection/ inflammation, device malfunction, reduce hip mobility/ hips lock up when getting out of chair, clostridium difficile and limping.Patient was not hospitalized.Seriousness criterion: disability for limping; required intervention for device malfunction, reaction to the injection/ inflammation; medically significant for clostridium difficile.The patient outcome was reported as unknown for all.A product technical complaint was initiated on 25-jun-2018 for synvisc one, batch number: 7rsl021, 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 is completed, corrective and preventive actions would be implemented.Follow up was received on 06-jul-2018.No new information was received.Follow up was received on 20-sep-2018.No new information was received.
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Limping/gait had changed considerably [limping].Degenerative joint disease of right knee [degenerative joint disease].([pain upon movement], [muscle atrophy], [joint tenderness], [joint clicking]).Clostridium difficile [clostridium difficile infection] ([stomach discomfort]).Reaction to the injection/ inflammation [joint inflammation] ([knee swelling], [knee pain], [joint warmth], [device malfunction], [joint effusion], [knee lock]).Bilateral hip osteoarthritis [hips osteoarthritis] ([joint range of motion decreased], [back pain], [arthralgia], [hip discomfort], [pain at rest], [joint effusion], [groin pain]).Mild lumbar spondylosis [lumbar spondylosis].Synovitis of right knee [synovitis of knee].Case narrative: upon internal review on 08-aug-2019, reporter causality was updated from not reported to related.Initial information received from united states on 19-jun-2018 regarding an unsolicited valid serious legal case received from other non-health care professional.This case involves a 63 years old male patient who experienced limping/gait had changed considerably, reaction to the injection/ inflammation (latency: 3 hours), synovitis of right knee (latency: 21 days), clostridium difficile, degenerative joint disease of right knee (latency: unknown) while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Also after 10 months and 21 days, patient had bilateral hip osteoarthritis and mild lumbar spondylosis.Medical history included medial meniscus tear of the right knee and right knee surgery (prior to the synvisc-one injections).Past medical treatment included synvisc one with four or five synvisc-one injections in the right knee (last injection on (b)(6) 2015; every 6 months getting the injections).Patient had no history of prosthetic device and allergy history to avian proteins, feathers, or egg products.Patient was able to bear the weight before injection.Surgical history included foot surgery, left knee surgery, left shoulder surgery.Family history included arthritis in father, cancer in mother.Patient was a non-smoker and had alcohol use.On (b)(6) 2017, patient visited primary care for right knee pain and the pain level was 3.On the same day, the patient received intra-articular hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml once (lot - 7rsl021) in the right knee for primary osteoarthritis of right knee and right knee pain.Patient had to walk home and after a while he started limping.The event was assessed as serious with disability as seriousness criteria.Patient got home that same day, elevated his right knee, three hours later experienced right knee swelling through his pants and knee pain.Patient took off his pants, his right knee was swelling there was pain in the right knee.On the scale of 1-10, the patient had pain of 10.The knee was hot to the touch.Patient wrapped the right knee in ice packs and kept it on for a couple of hours.His wife brought him some crutches he had.Patient used crutches to get around for a week and then a cane for three weeks.Patient was not able to bear the weight before injection.Patient emailed his physician that day on the next morning, he could not remember about his symptoms.On (b)(6) 2017, patient again visited physician as he had adverse reaction to synvisc one.The event was assessed as serious with intervention required as seriousness criteria.Patient's pain was 7 on pain scale.Physician found out that there was a recall of the lot number that was used for his injection of synvisc-one.Patient had persisting symptoms and he has been limited.He was still using a cane.He feels pain under his patella as he steps up.The knee was almost three times its normal size.Patient's right knee was examined and he had slight quadriceps atrophy.There were no skin changes but he had some fullness around the knee.Knee range of motion was 0 to about 120 degrees and he had pain at 120 degrees but passive and active motion in the range of between 0 and 120 was not painful.To palpation, he had a trace effusion.Patient also had palpable synovial bogginess.There was some diffuse tenderness mostly along the medial aspect of the knee.He had good strength and no pain with resisted knee flexion and extension.Patient's right lower leg was examined on the same day and there were no abnormalities.Patient was diagnosed with synovitis of right knee on the same day.On (b)(6) 2017, patient's right knee was aspirated of some blood-tinged fluid that was sent for culture and sensitivity as only about 5 ml was aspirated.No growth was observed for 5 and 14 days respectively.The physician put him on celebrex 200 mg daily for the pain and inflammation.Patient had tolerated this well in the past.Patient was also put on straight leg quadriceps strengthening exercises as physician thought a lot of his symptoms were related to quadriceps inhibition due to the effusion and the reaction.Patient tolerated the procedure well with no immediate complications.The physician gave prednisone when celebrex did not work.It took about a month to get the swelling completely down and not have any pain.On (b)(6) 2018, patient had mri of right knee that demonstrated complex displaced tear of the considerably degenerated posterior horn and body segment of the medial meniscus with interval truncation from prior exam, which may be reflective of partial meniscectomy.There was tricompartmental arthrosis, preferentially affecting the medial femorotibial compartment with advanced cartilage wear and interval progression from prior exam without an effusion or synovitis.Also reported, after injected with the synvisc-one patient started to have some stomach problems and in (b)(6) 2018 patient was diagnosed with c-diff.He said his was being treated for the clostridium difficile.Patient still had the stomach issues.On (b)(6) 2018, patient again visited physician as he started experiencing piercing and stabbing pain issues with both hips (moderate pain in right hip, serious pain in left hip) and both side of his groin with stiffness.Patient was feeling the pain externally of the hips and the inside of the groin.He said his hip joints feel like they would lock and he would have pain.Patient also had low back pain, right knee pain, clicking was getting worse, was not improving and gait had changed considerably.Patient's pain varied from 7 to 9 on pain scale.On (b)(6) 2018, patient visited again due to left anterior hip and groin pain.He had some symptoms on the right side but it was mostly on the left.Associated with this, patient had some night pain and some rest pain.He really could not attribute it to any kind of trauma or injury.It has now been ongoing for the last several weeks.His right knee was improved.Again, he had significant swelling after his synvisc injection.He continued to have some left knee pain.Patient had also more recently developed some left-sided low back pain with some radicular-type of pain.On the same day, patient's left hip was examined and there were no abnormalities.His hip motion was limited with flexion and internal rotation both of which caused him significant pain.External rotation was without pain passively.The same day, right hip was also inspected and there were no abnormalities.Range of motion was full but he had some slight pain with full flexion and internal rotation.Examination of both knees showed that there was no effusion.He had good strength and no pain with resisted knee flexion and extension.X-rays of both hips on the same day demonstrated no significant degenerative changes.There are no acute changes.He had slight offset at the head-neck junction bilaterally.Patient had significant left hip pain which does seem to be joint related and consistent with synovitis.Physician suspected that this was probably triggered when he was walking with an abnormal gait because of the right knee.Patient was recommended a mri.Right hip symptoms were similar to the left but much milder.Right knee degenerative joint disease with significant synovitis related to what appears to be contaminated synvisc-one injection.The event was assessed as serious with intervention required as seriousness criteria.On (b)(6) 2018, the patient reported his right knee locked after having a few days of knee pain.Patient had reduced hip mobility, hip pain and his hips locked up when getting out of chair or a car.He said if he twist his hips he would get a stabbing pain inside his groin area.The physician put him on another anti-inflammatory medication called: nabumetone (by impax) 750 mg twice a day to treat the pain.Patient felt that hips felt disconnected, had lower back pain and it was very tender.Patient was not hospitalized.On (b)(6) 2018, patient had mri of left hip that showed bilateral hip osteoarthritis, worse on the left, bilateral hip joint effusions, and mild lumbar spondylosis.On (b)(6) 2018, patient again had a visit and presented with left hip pain mostly in groin.Patient had physical therapy but with no relief.Pain limits his ability to cycle and worse with stairs.On the same day, patient's musculoskeletal exam was positive for arthralgias and joint stiffness, negative for joint swelling.On the same day, patient was diagnosed with primary osteoarthritis of left hip and chronic right-sided low back pain without sciatica.Patient would gradually resume normal activities as pain allowed.If pain persists, surgical evaluation would be considered.Patient should maintain a healthy weight to limit the stress effects on the knee as well as reduce inflammation in the body.During flare-ups, patient might need a short course of oral anti-inflammatory medications, may consider cortisone injections every 3 months as necessary and gel injections every 6 months as appropriate.Action taken: not applicable for all events.Corrective treatment: not reported for mild lumbar spondylosis, crutches and cane for limping, prednisone, celecoxib (celebrex) for degenerative joint disease of right knee and arthritis; captopril (impax) for arthritis, nabumetone (relafen) for other events outcome: unknown for all events.A product technical complaint was initiated on 25-jun-2018 for synvisc one, batch number: 7rsl021, 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 is completed, corrective and preventive actions would be implemented.Follow up was received on 06-jul-2018.No new information was received.Follow up was received on 20-sep-2018.No new information was received.Additional information was received on 08-aug-2019 from lawyer.The case classification was updated to legal.Indication of synvisc one was added.Patient's medical history and family history was added.Additional events of synovitis of right knee, degenerative joint disease of right knee, mild lumbar spondylosis and bilateral hip osteoarthritis were added along with details.Event reduce hip mobility/ hips lock up when getting out of chair was updated as symptom of primary osteoarthritis of left hip.Also symptoms of clostridium difficile were updated as symptom of primary osteoarthritis of left hip except abdominal discomfort.Symptom knee pain was updated to knee pain/pain under his patella as he steps up.Device malfunction was updated as symptom of arthritis.Labs were added.Outcome of joint effusion and joint swelling was updated to recovered.Upon internal review reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.
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