Persona® Trabecular Metal® 42-5008-068-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024469938), received between Oct 25, 2019 and Oct 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2019Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, STIFFNESS, INSTABILITY, LIMITED ROM, AND SWELLING. X-RAYS NOTED TIBIAL CUT WAS IN SIGNIFICANT VARUS. DURING THE REVISION PROCEDURE, HETEROTOPIC OSSIFICATION, POLY WEAR, AND LOOSENING OF THE FEMORAL COMPONENT WERE NOTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; Pain; Swelling

  MAUDE report 9238248 ↗