Harmony 74016265Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556746844), received between Feb 14, 2022 and Mar 25, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 12MM BROKE. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY; HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688120 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE UNIVERSAL INSERT SPACER SZ 5-6 12MM BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860091 ↗
• MalfunctionJul 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE INSERTING THE TWO PIECE UNIVERSAL INSERT SPACER SZ 5-6 12MM ON A PRIMARY TOTAL KNEE. IT BROKE AND ALL FOUR PIECES WERE RECOVERED. THEY WERE RELATIVELY LARGE AND EASY TO RECOVER BY HAND. NO INSTRUMENT WAS NEEDED TO RECOVER THE BROKEN 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 19767934 ↗
• MalfunctionApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN TRIALING THE UNIVERSAL INSERT SPACER SZ 5-6 12MM WAS PUT IN PROPERLY. UPON PUTTING THE LEG INTO EXTENSION THE SHIM BROKE. WE WERE ABLE TO MOVE FORWARD WITH THE CASE. THERE WERE NO PIECES TO BE RETRIEVED AS THE BROKEN PIECE EXITED THE WOUND ON ITS OWN. THERE ARE NOT OP REPORTS OR X-RAYS AVAILABLE. 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 19076951 ↗
• MalfunctionApr 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 12MM BROKE WHILE TRIALING. ALL PIECES RECOVERED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792394 ↗
• MalfunctionMar 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY IT WAS NOTICED THAT, THE SHIM OF ONE (1) UNIVERSAL INSERT SPACER SZ 5-6 12MM BROKE WHEN BEING REMOVED. 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 16632766 ↗
• MalfunctionMar 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY THE UNIVERSAL INSERT SPACER SZ 5-6 12MM BROKE IN HALF. 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 16547800 ↗
• MalfunctionJul 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA, ONE UNIVERSAL INSERT SPACER SZ 3-4 11MM AND ONE UNIVERSAL INSERT SPACER SZ 5-6 12MM BROKE. THE PIECES OF THE SPACERS WERE COLLECTED AND THROWN AWAY AFTER THE CASE. THERE WAS NO BROKEN DEBRIS, FROM THE TRIAL, LOCATED IN THE PATIENT. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090102 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT THE SHIM OF THE UNIVERSAL INSERT SPACER SZ 5-6 12MM SNAPPED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529779 ↗