It was reported that the patient dislocated both posteriorly and anteriorly.The surgeon decided to explant the cup, liner, head, and replace with a competitor product.The actis stem was retained and used a depuy 28 mm +8.5 biolox head.It was also indicated that there was loosening of the cup at the bone to implant interface.Doi: (b)(6) 2019.Dor: (b)(6) 2020, unknown affected side.
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 null device history batch null device history review null 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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