WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 33650014 |
Device Problem
Migration (4003)
|
Patient Problems
Pain (1994); Swelling (2091)
|
Event Date 03/23/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
|
|
Event Description
|
It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient had increased swelling and pain at early follow-up with evidence of tibial component loosening, which was not present on previous postop radiographs with increasing symptoms of pain.Revision total ankle surgery was recommended to treat this adverse event, but the patient was unable to schedule surgery due to insurance issues.Patient no longer wanted to participate in study, so the patient was removed.
|
|
Search Alerts/Recalls
|
|
|