Patient was revised due to a loose stem.It was undersized, and the porocoat beads separated from the stem.Examination of the reported device was not possible as it was not returned.It was reported the device loosening from the bone to implant interface after more than 20 years of implantation.A search of the complaints databases finds no other reports against the product and lot code combination since its release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.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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