Der states that patient tripped on a rug and fell down.This accident caused the cement mantle to crack.As a result the c stem subsided causing the patient to dislocate.The surgeon decided to revise the cup along with the stem.The cup was an asr cup implanted in 2008.It was well fixed and the patient didn¿t have any of the adverse issues with the cup.Because there weren¿t any metal head options, the cup needed to be replaced.It was also indicated that there was loosening at the cement to implant interface, depuy cement was used.Doi: 2008; dor: (b)(6) 2018; unknown side, no surgical delay.
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Product complaint # = > pc-(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, a follow-up medwatch will be filed as appropriate.
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