Catalog Number 129435120 |
Device Problems
Loss of or Failure to Bond (1068); Break (1069)
|
Patient Problem
Pain (1994)
|
Event Date 06/15/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).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.
|
|
Event Description
|
Patient was revised to address pain, instability, femoral and tibia loosening at an unknown interface.Competitor cement was used.It was also noted the stem on the tibial tray broke at the tray/stem connection.
|
|
Manufacturer Narrative
|
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incidents against the provided product/lot combination since release for distribution.Review of the device history records did not reveal any related manufacturing deviations or anomalies that would have contributed to the reported event.No product contribution to the reported event was identified.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|