Cadence Total Ankle System 10207112Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556852347), received between Dec 2, 2024 and Apr 29, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K151459); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ANKLE SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2018, THE CLINICAL SUBJECT EXPERIENCED A PERIPROSTHETIC MEDIAL MALLEOLUS FRACTURE ON (B)(6) 2018 WHILE COMPLETING PHYSICAL THERAPY. THIS ADVERSE EVENT WAS SOLVED BY A ORIF SURGERY ON (B)(6) 2018. THE CURRENT OUTCOME OF THE SUBJECT IS RECOVERED/RESOLVED

  Patient problems: Periprosthetic fracture

  MAUDE report 25024681 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A TAR ON (B)(6) 2018, PATIENT EXPERIENCED INFECTED TAR AND SIGNIFICANT WOUND BREAKDOWN DUE TO HIGH DOSE IV STEROIDS. AFTER THIS, HE HAD SEVERE CORP EXACERBATION. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2019, DURING WHICH A WASHOUT ALONG WITH A SPACER PLACEMENT WAS DONE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Impaired Healing; Medical device site infection; Pain; Wound Dehiscence

  MAUDE report 20824986 ↗
• InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A TAA WAS PERFORMED ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH A PERIPROSTHETIC LUCENCY AROUND THE TIBIAL COMPONENT ON (B)(6) 2019 AND HAD BEEN EXPERIENCING A SLIGHT ACHINESS WHEN ON THEIR LEG FOR A LONG PERIOD OF TIME. LATER, ON (B)(6) 2019, OSTEOLYSIS AROUND THEIR TIBIAL COMPONENT WAS CONFIRMED WITH A CT SCAN. THEREFORE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE SYSTEM WAS CHANGED FOR A SALTO XT. PATIENT'S CURRENT HEALTH STATUS WAS REPORTED AS RESOLVED.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 20819521 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151459. One submission often covers many models, so check the product and lot details in each record.

• Z-1192-2017 · Jan 20, 2017 · Terminated
  Integra Cadence Total Ankle System
• Z-2086-2016 · Apr 29, 2016 · Terminated
  Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and