NA 5301020061S1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613153095606), received between Feb 14, 2019 and Jul 15, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT THREE BLADES BROKE DURING A TOTAL HIP ARTHROPLASTY PROCEDURE. IT WAS FURTHER REPORTED THERE WAS A 5 MINUTE DELAY TO OBTAIN A NEW BLADE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE THIRD BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172967 ↗
• MalfunctionJul 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT THREE BLADES BROKE DURING A TOTAL HIP ARTHROPLASTY PROCEDURE. IT WAS FURTHER REPORTED THERE WAS A 5 MINUTE DELAY TO OBTAIN A NEW BLADE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172862 ↗
• MalfunctionJul 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT THREE BLADES BROKE DURING A TOTAL HIP ARTHROPLASTY PROCEDURE. IT WAS FURTHER REPORTED THERE WAS A 5 MINUTE DELAY TO OBTAIN A NEW BLADE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167074 ↗
• MalfunctionMay 18, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841648 ↗
• MalfunctionFeb 14, 2019Break

  DURING PROCEDURE, THE BLADES BROKE AND SNAPPED IN TWO. SECOND BLADE INSERTED WITH THE SAME RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8338951 ↗