Catalog Number 151650605 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); No Code Available (3191)
|
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
|
The primary surgery was performed on (b)(6) 2016 via tka for left knee joint.After the primary surgery, the patient complained the pain.Thus, it was reported that the revision surgery was performed by replacing the patella and the insert on (b)(6) 2018.The surgeon confirmed that there was no loosening at femur and tibia.No further information was provided by the hospital.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no products were returned.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 will be filed as appropriate.
|
|
Search Alerts/Recalls
|