Unknown Infinity Talar Component

Description of Event or Problem

The digital Stryker Prophecy team received a CT scan indicating that the patient may require a revision surgery for reasons as reported: " The tibial component is likely loose and although so far cultures of the joint fluid aspirate is negative and inflammatory markers are low the preliminary diagnosis would be a low grade infection and thus that would be the cause for the implant failing or having never really integrated into the tibial bone. Soft bone could be contributing, old age, large preop deformity, several surgeries having been performed previously in relatively a short period of time. As an Inbone or Invision tibia implantation requires the talus component to be removed for the retrograde procedure to be performed both components will need to be revised. Either an Inbone or an Invision on both sides could be used and that will be decided based on the Prophecy report and your calculations. I don't think the cause of failure is related to the Infinity prothesis itself"

Additional Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. A review of the Device History is not possible because the lot number was not communicated. Should additional information become available, it will be provided in a supplemental report.