Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Death (1802)
|
Event Date 03/20/2006 |
Event Type
Death
|
Manufacturer Narrative
|
Product complaint # (b)(4).Report source is a literature article.There is limited information regarding the reported death.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
The literature article entitled, "fatal cerebral emboli in the absence of a cardiac arterial-venous shunt" written by jennifer tucker ammon, md, cyna khalily, md, and d.Kevin lester, md published by the journal of arthroplasty vol.22 no.3 2007 accepted by publisher 20 march 2006 was reviewed.The article's purpose was to report on one case report of a (b)(6) year old mentally delayed female who underwent a cementless bipolar hemiarthroplasty for treatment of a displaced subcapital femoral neck fracture.A depuy femoral stem and femoral head was utilized.Intraoperatively she remained hemodynamically stable and well perfused with oxygen levels throughout operation.Six hours post op the patient had not awakened from surgery.Mri imaging revealed 22 fat emboli.She did not regain previous consciousness or function and 10 months later she died because of severe generalized debilitation.
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4) investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|