It was reported that the surgeon put on to explant a hip ball , bipolar shell and a pinnacle liner because of instability, and replace with a new hip ball and a constrained liner.During the procedure the surgeon explanted the hip ball, bipolar shell, and pinnacle liner.The srom stem and pinnacle cup were left in situ.A new 36mm srom hip ball and a 36mm x 56mm constrained liner was implanted.The surgeon was satisfied with the stability this construct provided.Doi: (b)(6) 2016.Dor: (b)(6) 2021.(left hip).
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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 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 device history record (mre) review, was not possible because the required lot code was not provided.
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