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Catalog Number 320-10-00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Fracture, Arm (2351)
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Event Date 02/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Index surgery: (b)(6) 2014.Non-revision of right shoulder components due to a non-displaced periprosthetic humeral fracture.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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As part of the pre-operative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or the postoperative period.The patient has a history of liver disease and hypertension which are patient conditions that could reasonably affect the patient and the reported event.There is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the underlying patient condition.This device is used for treatment not diagnosis.
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Event Description
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The patient was seen on (b)(6) 2017, no surgical intervention, the patient is splinting and bracing the arm/shoulder.Associated mfrs with this event: 1038671-2017-00117, 1038671-2017-00118, 1038671-2017-00119, 1038671-2017-00120, 1038671-2017-00121, 1038671-2017-00122 & 1038671-2017-00124.
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Search Alerts/Recalls
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