The patient was revised to address infection and loosening of the stem at the cement to implant interface.Competitor cement was used.He was brought to surgery for an i&d wash out and uni polar head exchange.During surgery, it was discovered that the cemented stem was loose and had a biofilm, mucus type film around it and needed to be removed.A new smaller stem and uni head were then implanted.Doi: (b)(6) 2017; dor: (b)(6) 2017.Unknown affected 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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