Harmony 74016266Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556746851), received between Sep 2, 2022 and Apr 5, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE PROCEDURE, A UNIVERSAL INSERT SPACER SZ 7-8 11MM BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786973 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 7-8 11MM WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 22291045 ↗
• MalfunctionApr 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IN THE TRIALING PHASE OF THE KNEE, WHEN A POLY INSERT HANDLE WAS USED TO REMOVE ONE (1) UNIVERSAL INSERT SPACER SZ 7-8 11MM, IT FRACTURED DESPITE NO EXCESSIVE FORCE BEING APPLIED. ALL PIECES WERE RETRIEVED FROM THE PATIENT THROUGH SUCTION AND FORCEPS. 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 19055391 ↗
• MalfunctionOct 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A UNIVERSAL INSERT SPACER SZ 7-8 11MM SNAPPED. IT IS UNCLEAR WHEN THE ISSUE WAS NOTICED RELATIVE TO THE SURGERY. HOWEVER, THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656569 ↗
• MalfunctionOct 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) UNIVERSAL INSERT SPACER SZ 7-8 11MM FRACTURED IN HALF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636176 ↗
• MalfunctionSep 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE UNIVERSAL INSERT SPACER SZ 7-8 11MM BROKE INTO TWO PIECES DURING REMOVAL. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353163 ↗