| Lot Number 7RSL021 |
| Device Problem
Device Contamination With Biological Material (2908)
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| Patient Problems
Arthralgia (2355); Joint Swelling (2356)
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| Event Date 11/01/2017 |
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Event Type
malfunction
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Event Description
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This case is cross referred with case: (b)(4) (cluster).
This unsolicited case from united states was received on (b)(6) 2018 from a medical doctor.
This case concerns a female patient (age: not reported) who received treatment with synvisc one and after unknown latency had temperature after injection, pain after injection, warmth in the knee, swelling after injection and knee was aspirated (latency: 2 days).
Also device malfunction was identified for the reported lot number.
No past drugs, medical history, concurrent conditions or concomitant medications were reported.
On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided) in right knee for knee pain.
Patient did not receive any other injections prior to the synvisc-one and it was not sure if the patient was given an injection at the same time of the synvisc-one.
On an unknown date, 2 day after receiving injection, patient was seen two days after the injection and was for complaints of pain and swelling.
It was unknown if the patient engaged in any activities such as tennis or jogging soon after the injection.
Patient was known to have pain and swelling in the affected knee.
Measurements of the knee circumference was not known.
It was unknown if the patient was able to bear weight before and after the injection.
The level of pain that the patient complained of was unknown.
It was unknown if the patient had a fever.
Blood work was done but, results and specific type of lab work completed was unknown.
Cultures were completed but, results of culture were unknown.
The patient had been treated with corticosteroids.
The patient had not been hospitalized yet, but the providers office noted that the patient may require surgery on the knee as a result of the injection.
On an unknown date, after unknown latency, patient had pain, swelling and a temperature after the injection.
Patient did not have fever results.
On (b)(6) 2017, 2 days after receiving injection, patient's knee was aspirated.
Patient did not have results of aspiration.
Blood work was obtained days after the injection in the right knee.
Patient was able to bear weight prior to the injection and after the injection.
Patient was still having warmth in the knee, pain and swelling.
Corrective treatment: corticosteroids for pain after injection, swelling after injection; aspiration for knee was aspirated (joint effusion); not reported for rest of the events.
Outcome: not recovered for pain after injection, swelling after injection and warmth in the knee; unknown for rest of the events.
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: required intervention for device malfunction, pain after injection and swelling after injection.
Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018.
This case concerns a patient who received synvisc-one injection from the recalled lot and later experienced fever, knee pain, knee swelling and warmth.
A temporal relationship can be established with the product administration.
Furthermore, the concerned lot number has been identified to have malfunction by the company.
Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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This case is cross referred with case:(b)(4).
(cluster).
This unsolicited case from united states was received on 09-feb-2018 from a medical doctor.
This case concerns a female patient (age: not reported) who received treatment with synvisc one and after unknown latency had temperature after injection, pain after injection, warmth in the knee, swelling after injection and knee was aspirated (latency: 2 days), chills and difficult to weight bear (latency: 0 day).
Also device malfunction was identified for the reported lot number.
No past drugs and concurrent conditions were reported.
Concomitant medication included ibuprofen (duexis).
Patient had a history of right knee effusion, obesity, arteriosclerosis, osteoarthritis right knee, medial meniscus tear right knee, cardiology and cellulitis.
Patient wear glasses.
Patient had no known allergy.
On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided) in right knee for knee pain.
The same day patient developed chills and difficult to weight bear.
Patient did not receive any other injections prior to the synvisc-one and it was not sure if the patient was given an injection at the same time of the synvisc-one.
On an unknown date, 2 day after receving injection, patient was seen two days after the injection and was for complaints of pain and swelling.
It was unknown if the patient engaged in any activities such as tennis or jogging soon after the injection.
Patient was known to have pain and swelling in the affected knee.
Measurements of the knee circumference was not known.
It was unknown if the patient was able to bear weight before and after the injection.
The level of pain that the patient complained of was unknown.
It was unknown if the patient had a fever.
Blood work was done but, results and specific type of lab work completed was unknown.
Cultures were completed but, results of culture were unknown.
The patient had been treated with corticosteriods.
The patient had not been hospitalized yet, but the providers office noted that the patient may require surgery on the knee as a result of the injection.
On an unknown date, after unknown latency, patient had pain, swelling and a temperature after the injection.
Patient did not have fever results.
On (b)(6) 2017, 2 days after receiving injection, patient's knee was aspirated.
Patient did not have results of aspiration.
Blood work was obtained days after the injection in the right knee.
Patient was able to bear weight prior to the injection and after the injection.
Patient was still having warmth in the knee, pain and swelling.
Corrective treatment: corticosteroids for pain after injection, swelling after injection; aspiration for knee was aspirated (joint effusion); not reported for rest of the events outcome: not recovered for pain after injection, chills and difficult to weight bear, device malfunction, swelling after injection and warmth in the knee; unknown for rest of the events a product technical complaint was initiated with global ptc number 52540 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: required intervention for device malfunction, pain after injection and swelling after injection additional information was received on 06-mar-2018.
Global ptc number was added.
Text was amendde accordingly.
Additional information was received on 16-apr-2018.
Additional event of chills and difficult to weight bear were added with details.
Outcome updated for device malfunction to not recovered.
Medical history added.
Concomitant medications updated.
Clinical course was updated.
Text was amended accordingly.
Pharmacovigilance comment: sanofi company comment dated 16-apr-18.
The follow up information received does not change previous case assessment.
This casse concerns a patient who received synvisc-one injection from the recalled lot and later experienced fever, knee pain, knee swelling and warmth.
A temporal relationship can be established with the product administration.
Furthermore, the concerned lot number has been identified to have malfunction by the company.
Therefore, the causal relationship of the events to the products cannot be excluded.
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