Reported event: an event regarding abnormal ion level and wear (trunnionosis) involving a metal head 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.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: "the indications portion of the operative notes that the patient had a v40 cocr femoral head in place.His cobalt level was 5.5 and his chromium level was 1.4.A pre-operative mri showed no , pseudotumor, fluid collection or muscle damage.Intraoperatively once the head was removed the surgeon commented that there was "dark fouling" on the trunnion.This was removed with a wet lap sponge and the trunnion was found to be in good condition.It is confirmed that the patient underwent revision surgery.His pre-operative cobalt and chromium levels were only slightly elevated and his pre-operative mri was benign.Intraoperatively he was found to have a small amount of "dark fouling" on the trunnion.Black material on the trunnion is not an uncommon finding in revision surgery.The trunnion itself was in "good condition".Should additional information become available i would be happy to further this assessment." product history review: review of the device history records indicate 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: it was reported that the patient suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.A review of the provided medical information by a clinical consultant indicated: "the indications portion of the operative notes that the patient had a v40 cocr femoral head in place.His cobalt level was 5.5 and his chromium level was 1.4.A pre-operative mri showed no , pseudotumor, fluid collection or muscle damage.Intraoperatively once the head was removed the surgeon commented that there was "dark fouling" on the trunnion.This was removed with a wet lap sponge and the trunnion was found to be in good condition.It is confirmed that the patient underwent revision surgery.His pre-operative cobalt and chromium levels were only slightly elevated and his pre-operative mri was benign.Intraoperatively he was found to have a small amount of "dark fouling" on the trunnion.Black material on the trunnion is not an uncommon finding in revision surgery.The trunnion itself was in "good condition".Should additional information become available i would be happy to further this assessment." the medical records provided for review were insufficient to confirm the reported events or determine root cause.Further information such as return of the device, pathology reports, pre- and post-operative reports 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.
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