MEDACTA INTERNATIONAL SA GAAK PRIMARY TIBIAL INSERT FIXED, FEMORAL COM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
|
Back to Search Results |
|
Model Number REF02.12.0410FR |
Device Problem
Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 01/26/2022 |
Event Type
Injury
|
Event Description
|
Patient was undergoing elective l knee replacement surgery.R knee implant was briefly implanted in the l knee, but rapidly recognized by vendor when he went to mark product in his log book.Wrong implant was able to be removed immediately as cement had not dried, thus avoiding a major revision surgery.Upon review of this incident, the team felt that the product should have enhanced laterality labelling.Fda safety report id# (b)(4).
|
|
Search Alerts/Recalls
|
|
|