Harmony 74016260Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556746790), received between Feb 14, 2022 and Oct 15, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) UNIVERSAL INSERT SPACER SZ 1-2 11MM HAD AN UNSPECIFIED ISSUE WHICH IS POTENTIALLY RELATED TO DEVICE FRACTURE AS PIECES WERE REPORTEDLY RETRIEVED. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING AN EQUIVALENT S+N BACKUP DEVICE. NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301281 ↗
• MalfunctionJul 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE WHILE BEING CLIPPED INTO THE TRIAL POLY. THERE WERE NO SMALL BROKEN PIECES LEFT IN THE PATIENT. THE SHIM BROKE INTO TWO OR THREE PIECES AND WAS REMOVED BY HAND. THERE ARE NO OP NOTES OR SURGICAL DETAILS AVAILABLE FROM THESE CASES. 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 22403449 ↗
• MalfunctionJun 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN IF ANY PIECE FELL INTO THE INCISION AND HOW THE PROCEDURE FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309699 ↗
• MalfunctionMay 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, TWO (2) UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE WHILE TRIALING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009658 ↗
• MalfunctionMar 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE UNIVERSAL INSERT SPACER SZ 1-2 11MM SHIM BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586576 ↗
• MalfunctionFeb 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE OFF WHILE TRIALING. 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 21446234 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360430 ↗
• MalfunctionJan 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE OFF WHILE REMOVING IT. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 21139178 ↗
• MalfunctionNov 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, A UNIVERSAL INSERT SPACER SZ 1-2 11MM WAS BROKEN. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674012 ↗
• MalfunctionOct 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE WHEN INSERTED DURING TRIALING AND SPLIT INTO THREE (3) 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 20471179 ↗
• MalfunctionAug 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING RANGE OF MOTION TRIALING IN A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991442 ↗
• MalfunctionNov 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE POSTERIOR TAB IN A UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE OFF. 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 18075023 ↗
• MalfunctionMay 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE OFF WHILE BEING USED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. NO INJURIES WERE REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865756 ↗
• MalfunctionApr 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE UNIVERSAL INSERT SPACER SZ 1-2 11MM DEVICE BROKE WHILE SURGEON WAS RUNNING KNEE THROUGH RANGE OF MOTION. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709666 ↗
• MalfunctionMar 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A UNIVERSAL INSERT SPACER SZ 1-2 11MM WAS FOUND BENT BEFORE USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN S+N BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. AFTER A VISUAL INSPECTION, IT WAS REVEALED A PIECE OF THE DEVICE IS FRACTURED OFF ON ONE SIDE, RENDERING IT INOPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488493 ↗
• MalfunctionNov 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, ONE (1) UNIVERSAL INSERT SPACER SZ 1-2 11MM BROKE WHEN THE SURGEON TRIED TO TAKE THE ATTACHMENT OFF. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785903 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT THE SHIM OF THE UNIVERSAL INSERT SPACER SZ 1-2 11MM SNAPPED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529773 ↗