Unknown Tibial component
Received Jul 28, 2026 · Event occurred Jul 3, 2026
Report 3010667733-2026-00982 · MDR key 50058416
Device
Generic name
Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Manufacturer
Wright Medical Technology IncCatalog number
Unk_WWA
Lot number
Unknown
Patient
Not reported
- Cyst(s)
- Inadequate Osseointegration
Narrative
Description of Event or Problem
The digital Stryker Prophecy team received a CT scan indicating that the patient may require a revision surgery of both the tibial and talar components. The plan is to revise tibia and talus components as there are findings on SPECT and recent CT with loosening of both components.Plan for revision from current infinity to inbone tibia and either inbone or invision talus.There is noted bone cyst formation and mild subsidence around implants with no other findings concerning for implant failure. Index procedure was performed at outside hospital on (b)(6) 2026.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.