Unix 4540-0308Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327101454), received between Jun 17, 2019 and Jun 17, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2019Naturally Worn; Naturally Worn

  REVISION OF UNIX UNILATERAL KNEE REPLACEMENT PERFORMED IN 2015. ORIGINAL IMPLANT WAS REVISED ON 22/5/19 DUE TO SEVERE POLY WEAR RESULTING IN METALLOSIS. DR. REMOVED THE EXISTING UNIX KNEE AND REVISED WITH A TRIATHLON TOTAL KNEE REPLACEMENT (CR FEMUR WITH STEMMED TIBIA). UPDATE 24/MAY/2019 WG: AS REPORTED IN HOW WAS ISSUE NOTICED "ISSUE WAS IDENTIFIED PRIOR TO MEDICAL PROCEDURE WHEN THE SURGEON PERFORMED A KNEE ARTHROSCOPY TO IDENTIFY THE PATIENT¿S COMPLAINTS OF PAIN AND METALLOSIS WAS OBSERVED".

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 8705968 ↗