Model Number ETPKNXXX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
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 al juhani et al reported 2 unrevised cases of "soft tissue infection" in patients 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.(b)(6) in (author of the article and owner of the study) please void the report.11.Corrected data: event not reportable.
|
|
Search Alerts/Recalls
|