Model Number 2015-24-000 |
Device Problem
Unintended Movement (3026)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/10/2021 |
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
|
Nurse reported a loose duraloc cup impactor which requires replacement (normal wear and tear).In addition, she reported an attune trial liner which lost its balseal and which also requires replacement.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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 review : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|