Catalog Number 155503040 |
Device Problem
Loss of Osseointegration (2408)
|
Patient Problem
Bone Fracture(s) (1870)
|
Event Date 11/04/2014 |
Event Type
Injury
|
Event Description
|
Patient was revised to address osteolysis.The talar was loose, found intraoperatively.
|
|
Manufacturer Narrative
|
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number is not available.
|
|
Manufacturer Narrative
|
The device associated with this report was not returned.Review of the device history records and/or a lot specific complaint database search was not possible for the product as the lot code required was not provided.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.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.
|
|
Search Alerts/Recalls
|