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Couldn't walk/could not get out of bed/needed help getting to the bathroom [unable to walk].Device malfunction [device malfunction].Not able to put pressure on knee/could not put weight on leg [weight bearing difficulty].Wetting the bed [bed wetting].Felt like there were knives in knee [discomfort in joints].Feeling tight [joint tightness].Real bad pain in the back of her knee that goes upto the back of her thigh/having extreme pain in her knee/knee starts hurting after 1/2 hour [knee pain] ([radiating pain]).Case narrative: based on additional information received on 07-sep-2018 from healthcare professional, this case became medically confirmed.This unsolicited case from united states was received on 19-dec-2017 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and was not able to put pressure on knee/could not put weight on leg and had real bad pain in the back of her knee that goes upto the back of her thigh/having extreme pain in her knee/knee starts hurting after 1/2 hour and after unknown latency started wetting the bed, felt like there were knives in knee, feeling tight and couldn't walk/could not get out of bed/needed help getting to the bathroom.Also device malfunction was identified for the reported lot number.The patient's past medical history parathyroidectomy on (b)(6) 2017, lumpectomy, hysterectomy, renal disease, arthritis, uterine cancer and tobacco user with former smoker.The patient's family history included cardiac disease in patient's father.The patient's past vaccination(s) was not provided.At the time of the event, the patient had ongoing hypertension, thyroid disorder, stress and drug hypersensitivity with allergic to statin.Concomitant medications included losartan potassium (losartan) for high blood pressure, amlodipine, fluoxetine for stress and levothyroxine sodium (levothyroxine).Patient was allergic to statin drugs and suffered muscle pain.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once at a dose of 1 df into the right knee (lot number: 7rsl021, expiry date: 31-may-2020) for knee osteoarthritis.It was reported that the patient did not receive a local anesthetic prior to the procedure.She states that the injection itself didn't "feel so bad".On the same day after receiving synvisc one injection, patient had extreme pain and swelling, could not put weight on leg for two weeks.It was reported that pain had continued and radiated into outer back knee and up thigh.Since an unknown date in the first two weeks post injection, after an unknown latency, she could not get out of bed and "wet the bed".The patient needed help getting to the bathroom, unable to make thanksgiving dinner or shop for christmas.Her knee started hurting after 1/2 hour.On an unknown date in 2017, after unknown latency right after her knee was numb and she could walk for about 1 hour after.On an unknown date in 2017, the patient started feeling tight she couldn't walk on it, put pressure on it, and it felt like there were knives in it.The patient had to use crutches and was afraid to call her doctor because it might make her knees worse.She described it as the "worst thing ever".It was reported that the patient was scheduled to receive the injection in her left knee but she canceled that and won't do that again.It was reported that it had been 1 month now and she still had real bad pain in the back of her knee that goes up to the back of her thigh.The patient could only walk up to 1 block now without feeling pain.The patient did not engage in any physical activity after injection.She states that she tried treating it with an elastic knee band, ice, and elevation.The patient has not seen anyone yet regarding her symptoms.Patient could only walk short distances after 6 weeks and was afraid to see doctor again.The patient was seeking compensation for the injection.After having the synvisc-one injection, she called her healthcare professional (hcp) office and was having extreme pain in her knee.Hcp told her to "give it a few more days".She was given a shot from the batch that was contaminated and had bad pain from this.All of november/december she could not walk.She stated that she had an adverse event to synvisc from the batch that was recalled back in (b)(6).Corrective treatment: crutches for couldn't walk/could not get out of bed/needed help getting to the bathroom; elastic knee band, ice, and elevation for real bad pain in the back of her knee that goes upto the back of her thigh/having extreme pain in her knee/knee starts hurting after 1/2 hour; not reported for rest of the events except device malfunction.Outcome: recovering for couldn't walk/could not get out of bed/needed help getting to the bathroom; unknown for wetting the bed, device malfunction, felt like there were knives in knee, feeling tight and not recovered for not able to put pressure on knee/could not put weight on leg and real bad pain in the back of her knee that goes upto the back of her thigh/having extreme pain in her knee/knee starts hurting after 1/2 hour.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.Seriousness criteria: disability for couldn't walk/could not get out of bed/needed help getting to the bathroom and device malfunction.Additional information was received on 19-dec-2017 and 12-jan-2018 (both the information was processed together with clock start date of 19-dec-2017) from patient.Patient's height was added.Medical history and concomitant medications were added.Additional event of device malfunction was added along with details.The event term not able to put pressure on knee was updated to not able to put pressure on knee/could not put weight on leg and outcome was updated form unknown to not recovered.Outcome of real bad pain in the back of her knee that goes upto the back of her thigh was updated form unknown to not recovered.Event onset of not able to put pressure on knee/could not put weight on leg and real bad pain in the back of her knee that goes upto the back of her thigh was updated from 2017 to (b)(6) 2017.Additional symptom of real bad pain in the back of her knee that goes upto the back of her thigh/radiates into outer back knee and up thigh was added.Investigation summary was added.Clinical course was updated and text was amended accordingly.Follow up was received on 23-jan-2018.No new information was received.Additional information was received on 15-may-2018 from the patient.Therapy start date and stop date was updated.Verbatim of event real bad pain in the back of her knee that goes upto the back of her thigh was updated to real bad pain in the back of her knee that goes upto the back of her thigh/having extreme pain in her knee/knee starts hurting after 1/2 hour.Additional event of wetting the bed was added along with details.Verbatim of event couldn't walk was updated to couldn't walk/could not get out of bed/needed help getting to the bathroom.Clinical course was updated.Text was amended accordingly.Additional information received on 07-sep-2018 from healthcare professional.This case became medically confirmed.The patient's past medical history of parathyroidectomy, lumpectomy, hysterectomy, renal disease, arthritis, uterine cancer and tobacco user with former smoker added.The patient's family history of cardiac disease added.Suspect product therapy date updated.Clinical course updated.Text amended accordingly.
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