NA 2108120000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540042071), received between Apr 7, 2023 and Oct 22, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501327 ↗
• InjuryApr 7, 2023Delivered as Unsterile Product; Device Contaminated at the User Facility; Delivered as Unsterile Product; Device Contaminated at the User Facility

  IT WAS REPORTED FOLLOWING A TOTAL HIP REPLACEMENT, THE PATIENT LATER PRESENTED WITH AN INFECTION. IT WAS ALSO REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AND NO DELAYS AT THE TIME OF THE SURGERY. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16702658 ↗
• InjuryApr 7, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED FOLLOWING A TOTAL HIP REPLACEMENT, THE PATIENT LATER PRESENTED WITH AN INFECTION. IT WAS ALSO REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AND NO DELAYS AT THE TIME OF THE SURGERY. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16702644 ↗