NA 00-5850-046-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024195998), received between Aug 30, 2023 and May 21, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMay 21, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED INTENSE PAIN IN THE LEFT THIGH SINCE INITIAL STAGES OF PREVIOUS SURGERIES. THE PATIENT WAS REVISED APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO LOOSENING. IT WAS NOTED THE EXPLANTED PROSTHETIC COMPONENTS SHOWED NO SIGNS OF REAL DAMAGE, BREAKAGE, WEAR OR OTHER MECHANICAL PROBLEMS, EXCEPT FOR THE ABSENCE OF OSTEOINTEGRATION OF THE FEMORAL STEM.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22063075 ↗
• InjuryOct 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 17907865 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PERIPROSTHETIC FEMUR FRACTURE AFTER A FALL APPROXIMATELY THREE (3) WEEKS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17655756 ↗