The manufacturer became aware of adverse events from the (b)(6) hip fracture register.The title of this report is ¿gamma 3 in the (b)(6) hip fracture register¿ which is associated with the gamma3 locking nail system, within that report, post-operative complications/ adverse events were reported, which occurred between (b)(6) 2005 and (b)(6) 2016.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 290 complaints were initiated for the revision surgeries retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery (re-osteosynthesis) due to unknown reason.About 217 out of 290 cases.It was also indicated that patient died within 60 days of revision surgery however the cause and date of death will not be disclosed.
|