The primary hip was done elsewhere so no information is available.The revision today was secondary to a change in cup position observed radiographically.A screw, a size 52 trident 1 cup, a 10 degree 32mm insert and a v40 32mm +4 lfit head were removed.The accolade 2 stem was determined to be stable.The cup was revised and head replaced.No further information is available from the surgeon or hospital.
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The following devices were also listed in this report: screw; cat # unk_jr; lot # unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding loosening involving an unknown shell was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to shell loosening.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device information, device return, pathology reports, pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : not available.
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