Model Number 5450-35-500 |
Device Problem
Loss of or Failure to Bond (1068)
|
Patient Problem
No Code Available (3191)
|
Event Date 12/10/2018 |
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.Occupation is a non-healthcare professional.(b)(4).
|
|
Event Description
|
The patient was revised to address loosening of the tibial component at the cement to implant interface.Doi: (b)(6) 2015; do: (b)(6) 2018; left knee.
|
|
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.Patient code: no code available (3191) is used to capture medical device removal.
|
|
Search Alerts/Recalls
|