An event regarding abnormal ion level and metallosis involving an unknown abg stem was reported.The event of abnormal ion level was confirmed by clinician review but the event of metallosis 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: a severe corrosion problem 5-years after a left hip abg revision hip arthroplasty with extremely high systemic cobalt and chrome levels has caused a symptomatic cardiac myopathy and possibly as well a pulmonary embolus a few months earlier.Chelation therapy using edta has reduced systemic metal ion levels as well as clinical symptoms significantly although parameters were still far from normal in oct 2018.Left hip exchange using a two-stage procedure was proposed and scheduled for oct 2018, but there is no information available about findings or the actual procedure performed.As such is the left hip source of the metal ions certain as cause for the cardiac problems although actual type or cause of corrosion problem cannot be established due to complete lack of relevant information.-product history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusions: a severe corrosion problem 5-years after a left hip abg revision hip arthroplasty with extremely high systemic cobalt and chrome levels has caused a symptomatic cardiac myopathy and possibly as well a pulmonary embolus a few months earlier.Chelation therapy using edta has reduced systemic metal ion levels as well as clinical symptoms significantly although parameters were still far from normal in oct 2018.Left hip exchange using a two-stage procedure was proposed and scheduled for oct 2018, but there is no information available about findings or the actual procedure performed.As such is the left hip source of the metal ions certain as cause for the cardiac problems although actual type or cause of corrosion problem cannot be established due to complete lack of relevant information.The exact cause of the event could not be determined because insufficient information was provided.Further information such as product details, orthopaedic records, x-rays and/or explant information 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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