Catalog Number NLS-380000B |
Device Problems
Nonstandard Device (1420); Noise, Audible (3273)
|
Patient Problem
Pain (1994)
|
Event Date 06/01/2012 |
Event Type
Injury
|
Event Description
|
It was reported that patient is experiencing pain since (b)(6) of this year.She also reports some clicking noise.She will follow up with her surgeon.
|
|
Manufacturer Narrative
|
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock met specifications.The complaint history review indicated that there have been similar events for the reported family.The event was confirmed.A voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported event is considered to be under the scope of this recall.
|
|
Search Alerts/Recalls
|