PERSONA® 42-5171-004-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024238619), received between Apr 27, 2022 and Jun 6, 2024 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TRIALING, THE INSTRUMENT CHIPPED. THERE WAS NO IMPACT TO PATIENT AND THEY WERE ABLE TO COMPLETE THE SURGERY WITH NO FURTHER ISSUES. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475416 ↗
• MalfunctionMar 27, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987598 ↗
• MalfunctionApr 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURED INSTRUMENT WAS NOTED FOLLOWING STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673549 ↗
• MalfunctionApr 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING A KNEE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219383 ↗