Corrected data: product available to stryker.An event regarding corrosion involving an unknown stem was reported.The event was confirmed.Method & results: --device evaluation and results: not performed as the device was not returned.However a mar conducted on the returned head concluded:- "damage consistent with the explantation process was observed on the head.Discoloration was observed on the taper of the head.Eds showed the discoloration was consistent with a corrosion process, material transfer from a hip stem and biological material.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: a review of the device history records could not be performed as the lot id is unknown.-complaint history review: a complaint history review could not be performed as the lot id is unknown.Conclusions: it was reported that the patient was revised due to pain wherein black debris were observed on the explanted devices.A mar conducted on the returned head concluded that discoloration consistent with a corrosion process, material transfer from a hip stem and biological material was observed on the taper of the head.However the root cause of the event could not be determined as sufficient information was not provided.Further information such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.Not returned to manufacturer.
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