The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.An event regarding loosening involving an exeter shell was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a medical review was performed and concluded: "there is no information at all about the conditions surrounding the cup loosening.No clinical info, no x-rays or any other info.As such can this case not be solved with the current information.More info, especially x-rays would be required to solve this case." -device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a medical review was performed and concluded: "there is no information at all about the conditions surrounding the cup loosening.No clinical info, no x-rays or any other info.As such can this case not be solved with the current information.More info, especially x-rays would be required to solve this case." if further information such as x-rays, patient history, additional operative notes and/or the device becomes available this investigation will be reopened.
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