Model Number 3125-1180S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Necrosis (1971); Osteomyelitis (4533)
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Event Date 11/24/2022 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device remains implanted in patient.
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Event Description
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As reported: "i take care of a patient after osteosynthesis of the right femur.The operation was carried out in (b)(6) 2019.The patient came to our department for femoral head necrosis with osteomyelitis and soft tissue abscess of the thigh.We need to extract the implants.This is a stryker 3 gamma nail system.The operation is scheduled for (b)(6) 2022.".
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Event Description
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As reported: "i take care of a patient after osteosynthesis of the right femur.The operation was carried out in (b)(6) 2019.The patient came to our department for femoral head necrosis with osteomyelitis and soft tissue abscess of the thigh.We need to extract the implants.This is a stryker 3 gamma nail system.The operation is scheduled for (b)(6) 2022.".
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Manufacturer Narrative
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The received x-ray was reviewed and the reported necrosis can be confirmed.Only based on this picture it is not possible to determine if the necrosis is in relation with the implants, especially as the devices were implanted for more than 3 years.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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