(b)(4).The head was depuy product; the liner was apparently competitor product, as only femoral components are listed on the sticker sheet from the primary surgery.No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.There was a suggestion that a competitor product was used in the construct.If this is the case it should be noted that using such product for articulation does not align with the design intent of the depuy hip system.This use of depuy devices is not recommended and is considered off label use.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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