The patient was revised to address metallosis.Update rec'd 12/09/2016 - clinical der rec'd indicating revision for adverse tissue reaction.No new information to change mdr decision.*complaint was updated on 12/27/2016.Update rec'd 1/11/2017: medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain , metallosis, stem in varus position (distal stem protrusion into the cortex) with migration.It also mentioned a pending femoral fracture distally to the isthmus and lateral cortex.Several office notes indicate a vertical cup (no measurements provided), but the cup wasn't revised during the revision.Lab levels provided indicate normal cobalt and chromium levels.The srom stem and sleeve are being added to the complaint.This complaint was updated on: 1/27/2017.
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No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible for the unknown lot code(s).Medical records were reviewed.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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