Catalog Number 122132448 |
Device Problems
Fracture (1260); Material Separation (1562)
|
Patient Problem
No Code Available (3191)
|
Event Date 06/04/2015 |
Event Type
Injury
|
Event Description
|
Patient was revised to address a liner disassociation.Intraoperatively, the liner was found to be fractured.Update rec'd (b)(4) 2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.There is no new information to report at this time.The complaint was updated on: (b)(4) 2015.
|
|
Manufacturer Narrative
|
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|