No device associated with this report was received for examination.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.(b)(4) has been undertaken to investigate attune post operative loosening further.The analyses and investigations eventually led to a new product development project, which will enhance fixation and make the product more robust to surgical technique per (b)(4).Corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|