Adverse Events in a Medical Device Registry
Type of medical device or patient population under study
All Kaiser Foundation Health Plan members receiving a total knee or hip replacement.
Manufacturer Name
Howmedica Osteonics Corp.
Manufacturer Name
Telefax medical
Medical Condition Associated with this Study
total joint replacement
Date event was reported
10/08/2021
Date event was reported
3/11/2022
Types of data or information collected
implant characteristics
patient demographics
surgical techniques
Type of Event
Potentially adverse event
Summary
A Pics line being place frayed at the center of the introducer which caused a piece to be sticking out
What challenges arose?
depth of data for manual review of adverse events that occur is too time consuming and intensive
Did the implant cause the patient immediate harm?
The fragment fell into the operative field unsterile.
Was this able to be used for the patient
No
Overall Results
Benefits patients and doctors to view what surgical techniques have the best results, and what implants have the best results.
Summary of Event
9mm implant was placed initially but replaced with 11mm. When switching the implants a locking wire broke but didn't stay with the implant