Catalog Number 20022XXXXX |
Device Problems
Fracture (1260); Loose or Intermittent Connection (1371); Radiation Overexposure (3017)
|
Patient Problem
Osteolysis (2377)
|
Event Type
Injury
|
Manufacturer Narrative
|
The investigation is not complete, trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 1043534-2016-00067, 00068.
|
|
Event Description
|
Allegedly, per roukis et al 2016 interoperative radiation exposure during revision total ankle replacement, there were two talar domes and polys revised due to talar loosening and osteolysis.There were eight intraoperative fractures in revisions.Seven of eight were malleolar fractures and one of eight was a talar body fracture.This was noted as a possible result of the limited stability the external guidance jig provided with large osseous voids and thin malleoli due to revision.These occurred while the jig was attached to the patient.
|
|
Manufacturer Narrative
|
This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.
|
|
Search Alerts/Recalls
|