An event regarding stem loosening involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned.-medical records received and evaluation: insufficient information was received for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, x-rays, operative reports and patient medical records would be helpful in investigating this event further.
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