Patient was revised for pain.Update 3/22/16-pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported patient had continual right hip pain, was unable to walk for long amounts of time, difficulty walking and doing household chores, metallosis, and renal issues possibly related to the cobalt chromium poisoning.Medical records reported effusion and metal debris per mri results.Revision surgical report noted large fluid collection of brown-tinged color, significant trunnionosis on femoral stem, trunnion and acetabular component, and metallosis.It appears that (b)(4) is a duplicate as it has dates of (b)(6) 2011 doi and unknown dor but there is no surgical report for dor.The pfs also does not list the date of (b)(6) 2015 as a surgical date.It is not possible to determine if this is truly a duplicate at this point.Coms will be updated and voided as needed when information to clarify if they are duplicates is received.Unknown stem added for corrosion/trunnionosis.
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No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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