Catalog Number 01.18.404 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 11/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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Batch review performed on 13 december 2020.Lot 182528: 100 items manufactured and released on 07-sep-2018.Expiration date: 2023-08-23.No anomalies found related to the problem.To date, 97 items of the same lot have been already sold without any similar reported even.
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Event Description
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Revision surgery performed 1 year and 8 months after primary surgery, due to a broken femur.Stem, ball head and bipolar head have been successfully revised.
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Manufacturer Narrative
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Clinical evaluation performed by medacta medical affairs department: postoperative femoral fracture, one year and 8 months after primary cementless tha.The fracture is due to a traumatic event.No reason to suspect that this event is due to a faulty device.
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Search Alerts/Recalls
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