Cadence™ 10207112Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780239192), received between Jun 4, 2021 and Jun 4, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 1651501-2021-00016 AND 1651501-2021-00017. CLINICAL STUDY - (B)(6) CLINICAL STUDY HAD AN ADVERSE EVENT REPORT OF ¿SCLEROSIS OF DISTAL TIBIA¿ WITH THE DESCRIPTION OF ¿PER PRINCIPAL INVESTIGATOR: INCREASED SCLEROSIS OF THE DISTAL TIBIA IMPLANT INTERFERENCE WITH SOME OSTEOLYSIS NOTED ON IMAGINING.¿ ¿PROBABLY RELATED¿ TO THE STUDY DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 11942993 ↗

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