Harmony 74016264Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00885556746837), received between Apr 25, 2022 and Apr 10, 2026 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Fracture” (25 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT, DURING A TKA, AN UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. 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 24845450 ↗
• MalfunctionApr 5, 2026Break

  IT WAS REPORTED THAT, DURING A TKA, A UNIVERSAL INSERT SPACER SZ 5-6 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 24787086 ↗
• MalfunctionMar 30, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, AS THE DOCTOR WAS TRIALING A POLY AND A UNIVERSAL INSERT SPACER SZ 5-6 11MM, THE SPACER SNAGGED ONTO THE TIBIA BASEPLATE, WAS HIT WITH A MALLET, AND SNAPPED A PIECE OFF. ALL PIECES WERE ACCOUNTED FOR AFTER THE INCIDENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724086 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT AT AN UNKNOWN POINT DURING A TKA, THE UNIVERSAL INSERT SPACER SZ 5-6 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 24620120 ↗
• MalfunctionMar 14, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE WHEN BEING REMOVED FROM KNEE. THE PROCEDURE WAS PERFORMED, 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 24600296 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE WHEN INSERTING THE POLY TRIAL INTO THE JOINT. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840238 ↗
• MalfunctionDec 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CLIP OF ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE WHILE REMOVING THE POLY TRIAL. THE BROKEN PIECE WAS RECOVERED. 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 23764380 ↗
• MalfunctionDec 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE IN TWO PIECES ON THE LEG OF THE DEVICE. IT FRACTURED DURING HANDLING ACTIVITIES. 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 23717108 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE UNIVERSAL INSERT SPACER SZ 5-6 11 MM BROKE WHILE IN USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696820 ↗
• MalfunctionDec 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIECE OF ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE WHILE TRIALING THE TOTAL KNEE WITH TRIAL IMPLANTS IN PLACE. ALL PIECES WERE RETRIEVED AND NO PIECES FELL IN THE PATIENT. THE PROCEDURE WAS PERFORMED, 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 23688580 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 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 23392330 ↗
• MalfunctionOct 21, 2025Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON WAS TRAILING USING ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 11MM BUILD UP, BUT THE TRIAL POLY WOULDN'T CLICK IN, SO THE SURGEON USED A MALLET TO TAP IT IN AND THE UNIVERSAL INSERT SPACER SZ 5-6 BROKE, THE PIECES WERE IN THE PATIENT AND WERE EASILY RETRIEVED BY HAND. ALL PIECES WERE RECOVERED. 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 23349666 ↗
• MalfunctionAug 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE. ALL PIECES WERE RETRIEVED AND THERE WAS NO EFFECT ON PATIENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PROCEDURE WAS RESUMED 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 22694159 ↗
• MalfunctionJul 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 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 22403429 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE INTO PIECES WHILE TRAILING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL 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 21932368 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKAS, THE UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE WHEN TRYING TO INSERT THE POLY TRIAL. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318463 ↗
• MalfunctionJan 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY THE SURGEON WAS TRIALING SIZE 5-6 11MM BCS INSERT TRIAL (9MM + 11MM SHIM). UPON REMOVAL OF TRIAL INSERT A SMALL PORTION OF WHITE UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE OFF. ONE SMALL BROKEN PIECE WAS REMOVED WITH A SMALL 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 21103154 ↗
• MalfunctionJan 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE UNIVERSAL INSERT SPACER SZ 5-6 11MM SNAPPED. NOTHING LOST INSIDE THE PATIENT. ALL PIECES FOUND. THE SURGERY WAS COMPLETED WITHOUT ANY DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102542 ↗
• MalfunctionJan 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 11MM'S PLASTIC PIECE BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN IF THERE WAS A S+N BACK-UP DEVICE AVAILABLE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060414 ↗
• MalfunctionOct 17, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE IN A CASE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT 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 20478087 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE DURING TRAILING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19969004 ↗
• MalfunctionJul 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THREE (3) UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE IN HALF. NO PIECES FELL INTO PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773562 ↗
• MalfunctionJul 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN REMOVING THE UNIVERSAL INSERT SPACER SZ 5-6 11MM FROM THE BASE PLATE, THE UNIVERSAL INSERT SPACER SZ 5-6 11MM CRACKED AND BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 19702686 ↗
• MalfunctionJun 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, A UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE IN HALF. NO PIECES FELL INTO PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581443 ↗
• MalfunctionApr 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, AN UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE IN HALF. IT SNAPPED WHEN TAKING THE POLY TRIAL OUT THE SHIM BROKE IN TWO. ALL PIECES WERE FOUND AND NOTHING INSIDE THE PATIENT. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH A S+N BACK-UP. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197651 ↗