Catalog Number UNK-EXTREM |
Device Problem
Naturally Worn (2988)
|
Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Osteolysis (2377)
|
Event Date 02/25/2014 |
Event Type
Injury
|
Event Description
|
Patient was revised to addres pain, poly wear and osteolysis.There was a cyst in the medical aspect of the tibia.
|
|
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.
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 as the product and 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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|