Harmony 74016263Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556746820), received between Dec 9, 2022 and Jan 30, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA THE UNIVERSAL INSERT SPACER SZ 3-4 12MM BROKE WHILE IMPACTING A TRIAL. ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS RESUMED, BUT IT IS UNKNOWN HOW, OR IF THIS CAUSED ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221112 ↗
• MalfunctionApr 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 12MM FRACTURED WHEN REMOVING THE POLY AFTER TRAILING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905119 ↗
• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON REMOVED A UNIVERSAL INSERT SPACER SZ 3-4 12MM AND THE SHIM BROKE UPON REMOVAL, PIECE FELL OUT ONTO FLOOR, AND NOTHING FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610179 ↗
• MalfunctionOct 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE "FOOT" OF ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 12MM SNAPPED OFF AND BROKE. ALL THE PIECES WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419626 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE PLASTIC OF ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 12MM FRACTURED UPON IMPACTION WHILE ATTEMPTING TO MALLET THE POLY INTO PLACE. THE PROCEDURE RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344803 ↗
• MalfunctionAug 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE SHIM FOR THE UNIVERSAL INSERT SPACER SZ 3-4 12MM BROKE ON ATTACHMENT AND INSERTION. AT THIS TIME, IT IS UNKNOWN IF PIECES FELL INSIDE THE PATIENT, OR IF THERE WAS ANY DELAY OR HOW THE PROCEDURE WAS FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20114273 ↗
• MalfunctionJun 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE UNIVERSAL INSERT SPACER SZ 3-4 12MM BROKE IN HALF. NO PIECES FELL INSIDE THE PATIENT. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY AND IF A DELAY WAS PRESENTED. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510606 ↗
• MalfunctionApr 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 12MM BROKE IN PIECES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011893 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 12MM BROKE APART WHILE TRAILING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948665 ↗