|
This unsolicited case from united states was received on 05-feb-2018 from the patient.This case concerns a female patient with unspecified age who received treatment with synvisc one injection and the same day the patient experienced swollen/ swelling that was really bad/swollen/swelling was not in the joint but above and around my joint and pain/ excruciating pain/pain that was really bad/bent over in pain; after few days patient was not able to use my leg and had discoloration of the knee; also, device malfunction was identified for the reported lot number.No relevant medical history and concurrent condition was reported.Patient had received synvisc previously 4 times without issue.Patient was immune-compromised.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection (dose, frequency and expiration date: not reported; lot number: 7rsl021) in the right knee.Within 24 hours, patient had swelling and pain.About 24-36 hours after patient received the injection, patient had swelling and pain that was really bad.Patient was bent over in pain and was not able to use the leg.Patient was in excruciating pain.Patient had discoloration of the knee (latency: few days).It was still swollen and still had pain.The swelling was not in the joint but above and around the joint.There was no fluid in the joint to aspirate with no infection and fever.Patient had lot of other health issues.Further reported, that over the course of weeks, patient was still recovering from it.Action taken: unknown corrective treatment: not reported for all outcome: recovering for swollen/swelling that was really bad/swollen/swelling was not in the joint but above and around my joint and pain/excruciating pain/pain that was really bad/bent over in pain; unknown for not able to use my leg and discoloration of my knee a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.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.Seriousness criterion: important medical event of device malfunction.
|
|
Device malfunction [device malfunction] discoloration of my knee [skin discoloration] not able to use my leg [leg discomfort] swollen/swelling that was really bad/swollen/swelling is not in the joint but above and around my joint/ increased swelling/ knee was huge [swelling of r knee] pain/excruciating pain/pain that was really bad/bent over in pain [knee pain] meniscus dmage/ complex tear in my meniscus [meniscus tear] increased fluid [knee effusion].Case narrative: this unsolicited case from united states was received on 05-feb-2018 from the patient.This case concerns a female patient with unspecified age who received treatment with synvisc one injection and the same day the patient experienced swollen/swelling that was really bad/swollen/swelling was not in the joint but above and around my joint/ increased swelling/ knee was huge and pain/excruciating pain/pain that was really bad/bent over in pain; after few days patient was not able to use my leg and had discoloration of the knee; also, device malfunction was identified for the reported lot number ; meniscus damage/ complex tear in my meniscus, increased fluid was also experienced by the patient.No relevant medical history and concurrent condition was reported.Patient had received synvisc previously 4 times without issue.Patient was immune-compromised.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection (dose, frequency and expiration date: not reported; lot number: 7rsl021) in the right knee.Within 24 hours, patient had swelling and pain.About 24-36 hours after patient received the injection, patient had swelling and pain that was really bad.Patient was bent over in pain and was not able to use the leg.Patient was in excruciating pain.Patient had discoloration of the knee (latency: few days).It was still swollen and still had pain.The swelling was not in the joint but above and around the joint.There was no fluid in the joint to aspirate with no infection and fever.Patient had lot of other health issues.Further reported, that over the course of weeks, patient was still recovering from it.On (b)(6) 2018, patient reported that he had five synvisc-one injections in the past but the last one was nothing like the other four and he had adverse events with it.Pt reported of having meniscus damage/ complex tear in meniscus.Patient was not sure if it had occurred due to increased swelling and increased fluid in his knee.It was also reported that the patient's knee was huge.Action taken: not applicable.Corrective treatment: not reported for all.Outcome: recovering for swollen/swelling that was really bad/swollen/swelling was not in the joint but above and around my joint and pain/excruciating pain/pain that was really bad/bent over in pain; unknown for not able to use my leg , increased fluid, meniscus damage/complex tear in meniscus and discoloration of my knee a pharmaceutical technical complaint (ptc) was initiated with (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.Seriousness criterion: important medical event of device malfunction follow-up was received on 26-feb-2018.Gptc number was added.Additional information was received on 22-jun-2018 from the patient.Additional events of increased fluid, meniscus damage/complex tear in meniscus were reported.Event verbatim updated for event swollen/swelling that was really bad/swollen/swelling was not in the joint but above and around my joint to swollen/swelling that was really bad/swollen/swelling was not in the joint but above and around my joint/ increased swelling/ knee was huge.Clinical course was updated and text amended accordingly.
|
