Harmony 74016262Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00885556746813), received between Feb 3, 2022 and Jun 7, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Fracture” (38 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE. NOTHING FELT INTO 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 25422699 ↗
• MalfunctionJun 1, 2026Fracture; Premature Separation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN TRIALING ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM, THE SPACER BECAME UNCOUPLED FROM THE TRIAL INSERT, IT THEN WEDGED BETWEEN THE TRIAL FEMUR AND TRIAL TIBIA BASE PLATE AND BROKE INTO A FEW PIECES. PIECES WERE RETRIEVED FROM WOUND WITH A TONSIL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THERE ARE NO OPERATIVE NOTES OR SURGICAL REPORTS AVAILABLE. THERE IS NO LOT NUMBER SINCE DEVICE WAS THROWN AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354224 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345417 ↗
• MalfunctionMay 8, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM FRACTURED. NO FRAGMENTS IN THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131077 ↗
• MalfunctionApr 30, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE IN HALF. THE TWO PIECES WERE DISPOSED OF PROPERLY BY HOSPITAL STAFF. NO PART WAS LEFT IN THE PATIENT¿S ANATOMY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049354 ↗
• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE WHEN TRIALING. 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 25017825 ↗
• MalfunctionApr 5, 2026Break

  IT WAS REPORTED THAT, DURING A TKA, AN UNIVERSAL INSERT SPACER SZ 3-4 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 24786781 ↗
• MalfunctionFeb 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE UNIVERSAL INSERT SPACER SZ 3-4 11MM SHIM SNAPPED WHILE TRIALING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232960 ↗
• MalfunctionDec 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE SHIM ON ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM SNAPPED WHEN IN USE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881289 ↗
• MalfunctionDec 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A UNIVERSAL INSERT SPACER SZ 3-4 11MM SNAPPED IN HALF WHEN BEING REMOVED. 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 23802969 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773639 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773615 ↗
• MalfunctionDec 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE UNIVERSAL INSERT SPACER SZ 5-6 11MM BROKE. 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 23769627 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE IN HALF. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459570 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM SNAPPED IN HALF. 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 22708674 ↗
• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE IN TWO WHEN TRYING TO SNAP IT ONTO THE 9 POLY. 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 22355246 ↗
• MalfunctionJun 18, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, TWO (2) UNIVERSAL INSERT SPACER SZ 3-4 11MM WERE BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED; HOWEVER, NO SURGICAL DELAY WAS REPORTED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283534 ↗
• MalfunctionJun 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM SNAPPED DURING USE. IT IS UNKNOWN HOW THE SURGERY WAS FINISHED. NO DELAY OR INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208220 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. 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 22032206 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM SNAPPED WHEN SURGEON PULLED OUT THE TRAIL POLY. ALL FRAGMENTS WERE EXTRACTED USING TWEEZERS AND SUCTION. NO PIECES WERE LEFT INSIDE 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 22023893 ↗
• MalfunctionMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), AFTER INSERTING THE TRIAL, A PIECE OF ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM SNAPPED OFF. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT BY HAND. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997305 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE WHEN TRYING TO INSERT IT INTO THE TIBIAL BASE PLATE TO CHECK FOR REFLECTION AND EXTENSION. ALL PIECES WERE COLLECTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 21920367 ↗
• MalfunctionApr 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM FRACTURED WHEN REMOVING THE POLY AFTER 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 21906142 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAYED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751412 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A UNIVERSAL INSERT SPACER SZ 3-4 11MM BROKE IN HALF. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749050 ↗