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Model Number TR-H200L-S |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Code Available (3191)
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Event Date 12/20/2013 |
Event Type
Injury
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Event Description
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During a radial head implantation surgery, a 7mm hole was broached with a 7mm broach; a 7mm trial stem fit correctly.When the 7mm sterile stem (with 20.0mm head, left) implant was implanted, it did not fit and would not stay in the broached hole.The surgeon then refit the broached hole with a 8mm sterile stem (with 22.0mm head, left) implant which fit satisfactorily.The mis-fit caused an extension in surgery time from a planned time of 3 hours to an actual time of 7 hours.
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Manufacturer Narrative
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Additional mdr associated with this event: 3025141-2014-00001, p/n tr-s0700-s, 7.0mm x 0.00mm stem.
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Search Alerts/Recalls
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