An event regarding disassociation involving an unknown head was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection: the device was not returned however images of the device were provided.The image was unremarkable dimensional and functional inspection was not performed as no devices were returned.-medical records received and evaluation: a review of the provided information by a clinical consultant concluded that : due to lack of information, the exact root cause of failure in 2015 with stem revision cannot be established although quite likely several procedure-related factors were the major and principal failure factors involved and not device-related factors.X-rays would be required to establish such a procedure-related root cause of failure with more certainty.Under the given conditions with very limited clinical information such a root cause nevertheless remains the most likely failure cause but cannot be proven with complete certainty based upon the available limited evidence.-device history review could not be performed as the device lot is unknown.-complaint history review could not be performed as the device lot is unknown conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, additional operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
|