Cadence™ 10208102Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780239321), received between Jun 4, 2021 and Jun 20, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• InjuryJun 20, 2022Break; Break

  IT WAS REPORTED THAT, 1.5 YEARS AFTER TOTAL ANKLE SURGERY WAS PERFORMED ON (B)(6) 2020, THE CADENCE TALAR DOME. SIZE 2. RIGHT HAD BROKEN PEGS. THE PATIENT EXPERIENCES PAIN AND DESCRIBES AN IMPORTANT DECREASE IN HIS QUALITY OF LIFE. IT IS UNKNOWN IF/HOW THIS ADVERSE EVENT WAS TREATED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 14742812 ↗
• InjuryJun 16, 2022Break; Break

  IT WAS REPORTED THAT, 1.5 YEARS AFTER TOTAL ANKLE SURGERY, THE CADENCE TALAR DOME. SIZE 2. RIGHT HAD BROKEN PEGS. THE PATIENT EXPERIENCES PAIN AND DESCRIBES AN IMPORTANT DECREASE IN HIS QUALITY OF LIFE. IT IS UNKNOWN IF/HOW THIS ADVERSE EVENT WAS TREATED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 14711075 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A

  Patient problems: Osteolysis

  MAUDE report 11942991 ↗

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