Model Number 1513-12-060 |
Device Problem
Difficult to Advance (2920)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/08/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Compass case report (b)(4): this patient has a left total attune knee done by surgeon.It is unknown when the knee was done.On xray, the femur has osteolysis and the tibia looks loose and has fallen into varus.The surgeon revised these components, and it turns out the femur and tibial tray were well fixed and difficult to remove.The patella was well fixed and retained.New implants were inserted.The tibia was prepped for an attune revision tray.The stem was overreamed by 1mm, the broach was fully seated.The real implant did not sit fully.It sat up 2mm.This seems to be a common event when using the attune revision system.All the trials sat perfectly, and the real implant would not seat fully.The pressfit is too much.No delay in surgery.
|
|
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.
|
|
Event Description
|
Additional information received indicated that the revision was due to malalignment.The patient had pain.The tray sitting up required the use of a thinner insert.
|
|
Manufacturer Narrative
|
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.Device history lot: a review of the device manufacturing records (dhr) was performed as part of this investigation.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude, that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
|
|
Search Alerts/Recalls
|
|