It was reported that the surgeon was impacting the revision tibial components in the revision tibia construct sat up several mm from where the trial sat when cementing.He had to remove tibia clear out all the cement that he just mixed for implants because it hardened.We had to open new tibial components for patient which caused a 35-40 min delay in the case.Doi: (b)(6) 2021, doe: (b)(6) 2021, right knee.
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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.Device history lot: a manufacturing record evaluation was performed for the finished device 151214050, lot d21083338 number, and no non-conformances / manufacturing irregularities were identified.(b)(4).
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