It was reported that once the revision surgery was completed however the surgeon recognized at x-ray after the surgery that it seemed there was a big gap between the insert and the tibial tray thus it was judged the insert might be floating.After that, the surgeon opened the incised wound immediately and confirmed the insert was not locked.The surgeon reinserted the insert and confirmed it was locked, closed the incised wound.The surgery was completed outside a 30 minutes delay.No further information was provided by the hospital.
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(b)(4).No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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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