Cadence Total Ankle System 10203102Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556851081), received between Jul 19, 2023 and Jan 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Crack; Fracture

  IT WAS REPORTED THAT, DURING AN ANKLE SURGERY, THE SURGEON SEATED THE TIBIAL IMPLANT USING ONE (1) CADENCE 45 DEGREE TIBIAL IMPACTOR TIP; FORCE WAS DRIVEN THROUGH THE INSTRUMENT TO CAUSE CRACKING AND FRACTURE OF BLACK PLASTIC PIECE OF THE CADENCE 45 DEGREE TIBIAL IMPACTOR TIP. THE PROCEDURE WAS ALREADY COMPLETED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188837 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TAR, SURGEON WAS USING THE CADENCE 45 DEGREE TIBIAL IMPACTOR TIP TO IMPACT A 3X LEFT TIBIAL IMPLANT. HOWEVER, THE BLACK TIP OF IMPACTOR BROKE WHILE DOING IMPLANT SEATING. THE BROKEN PIECE OF BLACK PLASTIC WAS RETRIEVED FROM THE BROKEN TIBIAL IMPACTOR TIP INSTRUMENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605082 ↗
• MalfunctionOct 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TOTAL ANKLE ARTHROPLASTY SURGERY DURING IMPACTION OF THE DEFINITIVE TIBIAL IMPLANT, SURGEON NOTICED THAT A PIECE OF ONE (1) CADENCE 45 DEGREE TIBIAL IMPACTOR TIP BROKE OFF AS HE REMOVED THE IMPACTOR FROM INSIDE THE PATIENT. THERE WAS ONE PIECE, HE IDENTIFIED IT IMMEDIATELY IN THE PATIENT, AND HE REMOVED IT WITHOUT FURTHER ISSUE WITH A KOCHER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397489 ↗
• MalfunctionApr 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TAR SURGERY, ONE (1) CADENCE 45-DEGREE TIBIAL IMPACTOR TIP CRACKED WHILE IMPACTING THE FINAL IMPLANTS, RESULTING IN SEPARATION OF PIECES. NO FRAGMENTS ENTERED THE SURGICAL SITE, AND ALL PIECES WERE ACCOUNTED FOR. THE IMPLANT WAS ALREADY FULLY IMPLANTED WHEN THE INCIDENT OCCURRED. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870425 ↗
• MalfunctionDec 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL ANKLE SURGERY, ONE (1) CADENCE 45 DEGREE TIBIAL IMPACTOR TIP BROKEN WHEN IMPLANTING THE TIBIAL COMPONENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031079 ↗
• MalfunctionNov 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ANKLE SURGERY, ONE (1) 45 DEGREE TIBIAL IMPACTOR TIP'S CORNER PLASTIC TIP BROKE OFF DURING INSERTION OF THE IMPLANT. THE INCIDENT WAS NOTICED AFTER IMPLANTATION WAS COMPLETE, THEREFORE THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY, USING THE SAME DEVICE. THE FRAGMENT FELL INSIDE THE WOUND BUT WAS RECOVERED WITHOUT ISSUE USING PICK-UPS. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604748 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER THE TIBIAL COMPONENT WAS IMPLANTED, THE CADENCE 45 DEGREE TIBIAL IMPACTOR TIP WAS REMOVED AND A PIECE WAS NOTED TO HAVE CRACKED OFF. THE PIECE WAS RETRIEVED WITHOUT FURTHER PROBLEMS OR DELAYS. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557910 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ANKLE SURGERY, ONE (1) 45 DEGREE TIBIAL IMPACTOR TIP WAS CRACKED. AS THE ISSUE WAS NOTICED AFTER IMPLANTATION, THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY, USING THE SAME DEVICE. A PIECE FELL INSIDE THE WOUND BUT WAS RECOVERED WITHOUT ISSUE USING PICK-UPS. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556276 ↗
• MalfunctionMar 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PLASTIC OF TWO (2) CADENCE 45 DEGREE TIBIAL IMPACTOR TIP BREAKS OFF DURING IMPLANTING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THIS CAUSES ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008000 ↗
• MalfunctionJul 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT, ONE (1) CADENCE 45 DEGREE TIBIAL IMPACTOR TIP BROKE WHEN SURGEON WAS USING IT TO IMPLANT TIBIAL COMPONENT IN PATIENT. ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347839 ↗