Harmony 74016249Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00885556746684), received between Dec 29, 2021 and May 31, 2026 — classified as 1 injury, 51 malfunctions.

The most frequently reported specific device problem is “Fracture” (44 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC JUNCTION OF ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR BROKE. 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 25342866 ↗
• MalfunctionMay 15, 2026Fracture

  IT WAS REPORTED THAT, DURING A TOTAL KNEE SURGERY, THE BASE OF THE POST OF ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR FRACTURED WHEN IMPACTING THE TIBIA BASEPLATE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE USING A FEMORAL IMPACTOR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187443 ↗
• MalfunctionMar 17, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CENTRAL PEG OF ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR SNAPPED OFF DURING IMPACTION. NO FRAGMENTS REPORTEDLY ENTERED 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 24624238 ↗
• MalfunctionFeb 4, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC TIP THAT GOES INTO ONE (1) MODULAR UNIVERSIAL TIBIAL IMPACTOR BROKE OFF WHILE IMPACTING. 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 24264938 ↗
• MalfunctionDec 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PEG OF ONE (1) MODULAR UNIVERSIAL TIBIAL IMPACTOR BROKE OFF ON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23900409 ↗
• MalfunctionDec 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) MODULAR UNIVERSIAL TIBIAL IMPACTOR BROKE WHILE IMPACTING. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING AN EQUIVALENT S+N BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741915 ↗
• MalfunctionNov 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE INTERFACE OF THE MODULAR UNIVERSAL TIBIAL IMPACTOR WHERE IT ATTACHES TO THE MODULAR HANDLE BROKE UPON IMPACTION. 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 23656636 ↗
• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR BROKE UPON IMPACTING ON THE TIBIA. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783020 ↗
• MalfunctionJun 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE MODULAR UNIVERSAL TIBIAL IMPACTOR BROKE IN USE. IT IS UNKNOWN IF ANY PIECE FELL INTO THE INCISION. 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 22185791 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE MODULAR UNIVERSIAL TIBIAL IMPACTOR BROKE WHILE USING IT. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313831 ↗
• MalfunctionDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE IMPACTING THE TIBIA, THE QUICK CONNECTOR OF ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR BROKE OFF. 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 20983027 ↗
• MalfunctionAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT THE PLASTIC OF TWO (2) MODULAR UNIVERSIAL TIBIAL IMPACTORS SNAPPED WHEN IMPACTING THE TIBIA. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS PERFORMED, 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 20076070 ↗
• MalfunctionAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, UPON FINAL IMPACTION OF TIBIAL IMPLANT THE MODULAR UNIVERSIAL TIBIAL IMPACTOR BROKE AT THE INSERTION POINT. 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 19968471 ↗
• MalfunctionJul 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, UPON IMPACTING THE FEMUR, ONE (1) MODULAR UNIVERSIAL TIBIAL IMPACTOR SNAPPED AT THE POINT BETWEEN THE PLASTIC STEM AND THE UNIVERSAL HANDLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19862846 ↗
• MalfunctionJun 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR SNAPPED OFF UPON IMPACTION. ALL THE BROKEN PIECES WERE ACCOUNTED FOR, AND NO PIECE FELL INTO THE PATIENT. THE PROCEDURE 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 19591840 ↗
• MalfunctionMay 30, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR BROKE OFF. NO PIECES 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 19431418 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MODULAR "UNIVERSAL" TIBIAL IMPACTOR BROKE IN PIECES WHEN IT WAS IN USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376914 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) MODULAR UNIVERSIAL TIBIAL IMPACTOR BROKE OFF WHILE IMPACTING THE TIBIA IMPLANT. 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 19376811 ↗
• MalfunctionMay 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, ONE (1) MODULAR UNIVERSIAL TIBIAL IMPACTOR WAS USED AS A SECONDARY IMPACTOR, AFTER USING THE METAL GUN POLY INSERT ON A TIBIA POLY IMPLANT. AFTER TWO TAPS WITH THE MALLET, THE IMPACTOR BROKE AT THE BASE OF THE PLASTIC. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF PIECES FELL INSIDE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256330 ↗
• MalfunctionMay 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE TIP OF ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240127 ↗
• MalfunctionMay 2, 2024Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE MODULAR UNIVERSAL TIBIAL IMPACTOR GOT FRACTURED, AFTER BEING USED. THE DEVICE FRACTURED BUT REMAINED IN ONE PIECE SO NOTHING REMAINED IN THE PATIENT. 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 19232962 ↗
• MalfunctionApr 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE PLASTIC ADAPTER END THAT INSERTS INTO THE MODULAR SYNC HANDLE OF TWO (2) MODULAR UNIVERSIAL TIBIAL IMPACTOR CRACKED AND BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, HOWEVER, THERE WAS NO DELAY. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097816 ↗
• MalfunctionApr 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE ATTACHMENT NUB OF A MODULAR UNIVERSIAL TIBIAL IMPACTOR BROKE OFF. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A S+N BACK-UP DEVICE. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096860 ↗
• MalfunctionMar 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CONNECTION TO MODULAR HANDLE OF ONE (1) MODULAR UNIVERSIAL TIBIAL IMPACTOR SNAPPED OFF. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PIECES OF THE BROKEN IMPACTOR FELL INSIDE THE PATIENT, AND NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926711 ↗
• MalfunctionMar 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) MODULAR UNIVERSAL TIBIAL IMPACTOR FRACTURE WHILE BEING USED ON A TIBIA BASEPLATE IMPLANT. 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 18887345 ↗