Model Number EBO101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bacterial Infection (1735)
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Event Date 11/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device discarded.
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Event Description
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It was reported that the patient had to undergo a revision surgery due to a free floating screw from the ulnar cap.Following this surgery the patient had to undergo another revision due to staphylococcus epidermidis.The initial plan was to swap the spool and cap, however the infection loosened the humeral and ulnar components.Components were removed and an antibiotic cement spacer was placed insitu.The patient will be need a subsequent operation after infection clears to have new components implanted.
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population.¿ a review of the labeling did not indicate any abnormalities.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.
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Event Description
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It was reported that the patient had to undergo a revision surgery due to a free floating screw from the ulnar cap.Following this surgery the patient had to undergo another revision due to staphylococcus epidermidis.The initial plan was to swap the spool and cap, however the infection loosened the humeral and ulnar components.Components were removed and an antibiotic cement spacer was placed insitu.The patient will be need a subsequent operation after infection clears to have new components implanted.
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Search Alerts/Recalls
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