It was reported that the surgeon broached to a 5 hi offset actis, it fit perfectly.He calcar planed even with the broach, did a trial reduction with x-rays.The real actis implant 101012050 upon impaction would not seat it was 2 mm proud(collar).It was bilateral and the same situation occurred on the left side.
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Product complaint (b)(4).Investigation summary no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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