Pinnacle claim submission form and medical records received.After review of medical records, during the primary surgery, after trialing with a size 6 high offset broach and then impacting the definitive prosthesis, it was noted that the prosthesis was a little more proud than the broach by a few extra millimeters.Doe: (b)(6) 2009.
|
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 complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : c5egy1000.Device history batch : null.Device history review : review of the device manufacturing record found no deviations or anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|