Catalog Number 150621005 |
Device Problem
Use of Device Problem (1670)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 02/01/2024 |
Event Type
Injury
|
Event Description
|
It was reported that this patient's knee was revised due to malalignment and primary attune tibial insert and tibial tray were removed, and tibia was then recut to correct the malalignment.A replacement tibial insert, and an attune revision tibial tray with augments and a short cemented stem, were then implanted.Patient's patella was also resurfaced, since it had not been resurfaced during his primary procedure.There was no surgical delay.Doi: (b)(6) 2023.Dor: (b)(6) 2024.Affected side: left knee.
|
|
Manufacturer Narrative
|
Product complaint #: (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|
|