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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Collapse (2416); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).Patient weight is unknown.Date of post-operative event is unknown.This report is for one (1) unknown tfna nail.Additional product codes for this report include hwc.(other): without a valid part and lot number, the udi is not available.Per facility, the complainant parts will not be returned for manufacturer review/investigation.(b)(4).Unknown, as specific part and lot numbers for the complainant nail were not provided.However, the likely 510k (based on the type of construct) is k131548.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that a patient was originally treated for a hip fracture with the implantation of a trochanteric femoral nail advanced (tfna) system on (b)(6) 2016.The construct included the following devices: one (1) femoral nail, one (1) lag screw, and two (2) locking bolts.On an unknown post-operative date, the patient presented with a collapsed femoral neck and femoral head bone.As a result, the patient was returned to the operating room for revision surgery on (b)(6) 2016.During the revision, the surgeon successfully removed all of the original tfna hardware with no reported issues.The patient was then revised to a depuy total hip replacement.The patient's status post-operatively was reported as stable.This report is for one (1) unknown tfna nail.This report is 2 of 3 for (b)(4).
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Search Alerts/Recalls
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