Cadence™ 10207101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780239130), received between Jul 18, 2022 and Jul 18, 2022 — 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.

• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT ANKLE JOINT REPLACEMENT HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED VARUS POSITIONING OF THE PROSTHESIS, ANKLE EQUINUS, ANKLE ANKYLOSIS AND ANTEROMEDIAL ANKLE PAIN. AN ADDITIONAL SURGERY WAS CONDUCTED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, A SUPRAMALLEOLAR CLOSING WEDGE OSTEOTOMY, AN ACHILLES TENDON LENGTHENING AND AN ANTERIOR AND POSTERIOR ANKLE ARTHROLYSIS WERE PERFORMED. TWO AND A HALF (2.5) MONTHS AFTER THIS PROCEDURE, THE PATIENT OSTEOTOMIES FUSION CONTINUES TO DEVELOP FROM A RADIOLOGICAL POINT OF VIEW AND THE FOOT IS PLANTIGRADE.

  Patient problems: Arthralgia; Deformity/ Disfigurement

  MAUDE report 15038546 ↗

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