Model Number EISXXXXX |
Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
Injury
|
Manufacturer Narrative
|
This event will be updated once the investigation is complete.Trends will be evaluated.
|
|
Event Description
|
Allegedly, a study by (b)(6) et al reported 1 unrevised case of "instability/dislocation" in a patient implanted with an evolution primary knee.
|
|
Manufacturer Narrative
|
10.Additional information received on 16-aug-2021.Adverse events reported in the article are not medical device related, as clarified by dr.Wazzan in saudi arabia (author of the article and owner of the study) please void the report.11.Corrected data: event not reportable.
|
|
Search Alerts/Recalls
|