The patient was revised to address pain and loosening of the tibial component at the cement to implant interface.Cement manufacturer was unknown.It was also reported that the tibia came out with some force but it had not completely debonded between the cement and the tray.There was still some cement attached to the tray.The tray and insert were removed and they put in a stemmed, sleeved attune revision with a cr rp insert.Doi: (b)(6) 2015; dor: (b)(6) 2019, left knee.
|
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).Investigation summary : the device associated with this report was not received for examination.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.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.
|