Device Problem
Failure To Adhere Or Bond (1031)
|
Patient Problem
Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
Information was received via journal article.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc3705234/ (b)(4) other device used: catalog #unk, unknown coonrad/morrey ulnar assembly, lot #unk.This report will be amended when our investigation is complete.
|
|
Event Description
|
It has been reported that a (b)(6) female patient with a right side replacement experienced a loose component, pain and was revised.
|
|
Manufacturer Narrative
|
This report is being amended to reflect changes in sections operative notes were requested however none provided.Relevant medical history and adherence to rehabilitation protocol are unknown.No devices or photos were received; therefore the condition of the components is unknown.The part and lot numbers of the product are unknown; therefore the device history records could not be reviewed.These products were used for treatment.The complaint history for these products could not be reviewed due to the lack of lot numbers.It could not be confirmed if the devices are an approved and compatible combination.A definitive root cause cannot be determined with the information provided.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer biomet considers the investigation closed.
|
|
Search Alerts/Recalls
|