The complaints of pain and has grossly elevated metal ions.Patient underwent revision for failed left tha, metallosis.Operative notes reported that there was abundant scar/fibrous tissue present with associated with sinovitis.There was a minimal amount of corrosion present at the neck/trunion junction on the stem, but overall the corrosion form the head/neck articulation was minimal.Doi: (b)(6) 2009; dor: (b)(6) 2019; left hip.
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
|