Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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).The complaint was received into the company with the following comment: the primary surgery was performed via tha (date of primary surgery was unknown).The surgeon recognized that dissociation and dislocation occurred at the patient¿s hip joint in feb 2019.Since it was also recognized that there was suspected armd, the revision surgery was performed on mar 5th 2019 by replacing the stem (p/n: 134524000), the cup (manufactured by kyocera), the liner (p/n: 121887354), the head (962711000).The surgery was completed without a surgical delay.No further information is available.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The products shall be retained for future reference in secure location as per procedures unless specifically requested back by the complainant.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, a follow-up medwatch will be filed as appropriate.
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