After review of medical records, it was reported that the patient got up out of bed and tore the acetabular component out, fractured around it.Then the patient was revised for displaced left acetabular component/ periprosthetic fracture.Operative notes reported that about 300 ml hematoma was expelled.The constrained liner was still locked around the prosthetic ball but it had torn the shell out of her native acetabular fossa.Screws has been added to the complaint.Doi: (b)(6) 2017; dor: (b)(6) 2017; left hip.
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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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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.H10 additional narrative: corrected: h6.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.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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