An event regarding corrosion and abnormal ion level involving a accolade stem was reported.The event of corrosion was confirmed.Abnormal ion level was not confirmed.Method & results: product evaluation and results: material, dimensional, functional and material analysis could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: conclusion/assessment: the patient underwent a routine total hip arthroplasty in 2011.No medical records were provided for the preoperative or postoperative course.She apparently underwent revision hip arthroplasty in 2022.Again, no medical records, preoperative evaluation, radiographs or postoperative care records were provided for review.At the time of revision surgery.There were a small amount of corrosive products noted on the trunnion that were wiped free and the head and liner were exchanged.Increased metal levels were noted in the operative report but not provided for review.No laboratory studies were provided for review.This case is apparently evolved into a legal filing.Event confirmation: a primary total left hip arthroplasty in 2011 can be confirmed.A revision left hip arthroplasty in 2022 can be confirmed.Increased metal levels cannot be confirmed.Injury cannot be confirmed.Device recall cannot be confirmed.Root cause: the root cause for the total hip arthroplasty in 2011 was hip arthritis.The root cause for the revision hip arthroplasty in 2022 was stated as failed left hip arthroplasty secondary to trunnion corrosion, however corrosion products, increased metal levels, or the reasons for failure cannot be confirmed as a root cause cannot be ascertained.Product history review: a review of the device history records indicates devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical information by a clinical consultant indicated: conclusion/assessment: the patient underwent a routine total hip arthroplasty in 2011.No medical records were provided for the preoperative or postoperative course.She apparently underwent revision hip arthroplasty in 2022.Again, no medical records, preoperative evaluation, radiographs or postoperative care records were provided for review.At the time of revision surgery.There were a small amount of corrosive products noted on the trunnion that were wiped free and the head and liner were exchanged.Increased metal levels were noted in the operative report but not provided for review.No laboratory studies were provided for review.This case is apparently evolved into a legal filing.Event confirmation: a primary total left hip arthroplasty in 2011 can be confirmed.A revision left hip arthroplasty in 2022 can be confirmed.Increased metal levels cannot be confirmed.Injury cannot be confirmed.Device recall cannot be confirmed.Root cause: the root cause for the total hip arthroplasty in 2011 was hip arthritis.The root cause for the revision hip arthroplasty in 2022 was stated as failed left hip arthroplasty secondary to trunnion corrosion, however corrosion products, increased metal levels, or the reasons for failure cannot be confirmed as a root cause cannot be ascertained.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
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