Catalog Number 254500138 |
Device Problems
Break (1069); Crack (1135)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
|
Event Date 09/20/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
|
|
Event Description
|
It was reported that both attune trial extractors broke as the surgeon attempted to remove the articulation trial.These events happened in two different surgeries on the same day.Both extractors broke in similar places and a piece did crack off, however neither fell in the patient and were both retrieved.No adverse events were reported and the surgery was completed successfully with minimal delay in both cases.As for the attune articulation surface, this event did not occur during surgery.During routine inspection in spd, it was noted that the spring on the articulation surface is damaged and needs to be replaced.
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
|
|
Manufacturer Narrative
|
Additional narrative: the devices associated with this report were not returned.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will 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
|
Pc(b)(4).Investigation summary : examination of the returned device confirms the reported event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
|
|
Manufacturer Narrative
|
Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
|
|
Search Alerts/Recalls
|