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Catalog Number 456.305 |
Device Problem
Unintended Movement (3026)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Patient identifier not available for reporting.Date of device migration not known.(b)(4).Lot number unknown.Date of implant reported as three (3) weeks prior to explant.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device therapy date reported as three (3) weeks prior to explant.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was 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 implanted with a trochanteric fixation nail (tfn) and helical blade on an unknown date approximately three weeks prior to explant date for a right fractured femur.On an unknown date, the patient returned to the emergency department complaining of pain.X-rays taken at the emergency department identified a varus deformity and a possible cut-out of the nail and helical blade at the interior proximal femur.Patient was returned to the operating room on (b)(6) 2017 for revision.The revision procedure included femur reduction and repositioning a new guide wire into the femoral neck, and a new nail and helical blade were implanted to correct the varus deformity.This was confirmed with ap and lateral x-rays taken during the procedure.There was no surgical delay, and the revision surgery was completed.The patient remained stable during and following the procedure.Concomitant device reported: tfn nail (part 456.414s, lot number unknown, quantity 1) this report is for one (1) 11.0mm helical blade.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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