Model Number 1504-00-224 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Not Applicable (3189); No Code Available (3191)
|
Event Date 03/29/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(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
|
Received medical records on 06/26/2018.Medical records reviewed for mdr reportability.Right attune total knee revised to address pain and instability.Revising surgeon noted that the pcl was incompetent, on a cr non-stabilized knee replacement.Attune femur, tibial tray, and tibial insert components were revised to competitor products; the attune patella component was retained.Competitor cement was used during the primary surgery.Doi: (b)(6) 2016; dor: (b)(6) 2017; (right knee).
|
|
Manufacturer Narrative
|
(b)(4).No device associated with this report was 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.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).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H6 patient code: no code available (3191) was used to capture joint instability and surgical intervention.
|
|
Search Alerts/Recalls
|