WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
Unspecified Infection (1930)
|
Event Type
Injury
|
Manufacturer Narrative
|
Literature citation: cody et al.Increased early revision rate with the infinity total ankle prosthesis.Foot & ankle international.2018.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
|
Allegedly, it was reported by cody et al.In an article titled "increased early revision rate with the infinity total ankle prosthesis" it was reported that sixteen ankles (10%) in 15 patients with a mean age of 63 years (range, 45-78 years) underwent revision a mean 13 months postoperatively (range, 2-28 months), divided proportionately between the 2 surgeons such that each surgeon had a 10% revision rate.Revision was performed most commonly for symptomatic (painful) tibial component loosening (6 ankles, 3.8%) and deep infection (6 ankles, 3.8%).
|
|
Search Alerts/Recalls
|
|
|