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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Swelling (2091); Impaired Healing (2378)
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Event Type
Injury
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Manufacturer Narrative
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Patient weight is unknown.Additional product codes: hrs and hwc.This report is for an unknown quantity of unknown products (e.G.Pins, cables, plate, screws)/unknown lots.Part and lot numbers are unknown; udi numbers are unknown.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 due to infection, non-union, and red swollen of left thigh that was draining through small open wound around femur, patient was revised on (b)(6) 2015 to removed hardware from (b)(6) 2012 and (b)(6) 2014.All hardware was removed intact.Patient was treated with possible infection and an antibiotic nail was made by the surgeon and implanted in the medullary canal.Procedure was successfully completed and no surgical delays were reported.Patient will return to operating room at later date, once infection has cleared for revision fixation.Patient/status outcome was reported as fine.This report is for an unknown quantity of unknown products.This is report 15 of 15 for (b)(4).
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Search Alerts/Recalls
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