An event regarding disassociation, altr, and wear involving an unknown accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: not performed as no lot code information was provided.Complaint history review: not performed as no lot code information was provided.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device identification and return, pre and post operative x-rays, pathology reports, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.Device not available.
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It was reported that the patient's left hip was revised due to disassociation of the head from the stem.Surgeon reported metallosis, trunnion wear, and black tissue was observed in the patient.A 5.5 accolade tmzf stem and 36 +5 lfit v40 head were revised to a restoration modular stem construct and ceramic head.Rep reported that x-rays, medical records, and additional information are not available.
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