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Catalog Number 456.305S |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Failure of Implant (1924); Irritation (1941); Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient height is (b)(6).Additional device product code is hwc.Other number¿udi: (b)(4).(therapy date): unknown.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 revision surgery including hardware removal and replacement was performed due to helical blade migration, patient pain and skin irritation.It is reported patient was implanted with a trochanteric femoral nail (tfn) and a 100mm helical blade on unknown date.The femoral head reduced as intended, causing the blade to back out.The patient reported pain from skin irritation where blade backed out.The patient was returned to surgery on (b)(6) 2017 where surgeon removed the helical blade and replaced it with an 80mm helical blade.The surgery was completed successfully with no delay and no harm to patient.Concomitant devices reported: trochanteric femoral nail (part number unknown, lot number unknown, quantity 1).This report is 1 of 1 for (b)(4).
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Search Alerts/Recalls
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