Persona® Trabecular Metal® 42-5028-060-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024230743), received between Feb 7, 2020 and Sep 6, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 20156219 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. A FEW DAYS FOLLOWING THE SURGERY, WHILE THE PATIENT WAS STILL IN THE HOSPITAL, THEY MIS-STEPPED AND TORE MULTIPLE LIGAMENTS. PATIENT WAS REVISED A WEEK POST-IMPLANTATION DUE TO LIGAMENT AND SOFT TISSUE DAMAGE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 19323078 ↗
• InjurySep 6, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 11 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, INSTABILITY, AND TIBIAL SUBSIDENCE. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15361584 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVEN MONTHS POST IMPLANTATION DUE TO PAIN AND SWELLING. DURING REVISION PROCEDURE, SURGEON NOTED CLEAR SYNOVIAL FLUID, BUT THAT SYNOVIUM WAS INFLAMED AND SENT TISSUE BIOPSY¿S FOR EVALUATION. HE ALSO NOTED THAT THERE WAS VERY LITTLE BONE IN GROWTH IN THE TIBIAL BASE PLATE AND FEMUR PROSTHESIS. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12561556 ↗
• InjuryFeb 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT WAS EXPERIENCING STIFFNESS AND CONSEQUENTLY UNDERWENT A MANIPULATION UNDER ANESTHESIA WITH INJECTION OF THE RIGHT KNEE. APPROXIMATELY 2 WEEKS POST MANIPULATION, THE PATIENT'S SWELLING HAD REPORTEDLY RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9681152 ↗