Persona® 42-5706-064-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024576506), received between Dec 30, 2024 and Feb 11, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT BEGAN EXPERIENCING RESTRICTED RANGE OF MOTION, PERSISTENT PAIN, WALKING DIFFICULTIES, SWELLING, AND DIFFICULTY PERFORMING DAILY ACTIVITIES SEVEN MONTHS POST IMPLANTATION. BETWEEN RADIOGRAPHIC IMAGING AND ASSESSMENT, PATELLAR BAJA, ABNORMAL PATELLAR TRACKING, AND ABNORMAL PATELLAR HEIGHT WAS FOUND. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY AND WAS REFERRED TO NEUROSURGERY FOR A POTENTIAL GENICULATE BLOCK. SYMPTOMS WERE ONGOING WITH AN INCREASING FEEING OF LOCKING AND INSTABILITY IN THE KNEE. X-RAYS SHOWED TIBIAL AND FEMORAL RADIOLUCENCY, AND A BONE SCAN SHOWED REUPTAKE THROUGHOUT THE KNEE. THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED ONE YEAR, ONE MONTH LATER DUE TO LOOSENING. PATELLAR IMPLANT REMAINED. ARTICULAR SURFACE REPLACED AS A BEST PRACTICE. THE STUDY SITE HAS MINIMAL INFORMATION AS THE REVISION OCCURRED AT AN OUTSIDE FACILITY.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Loss of Range of Motion; Pain; Radiolucent Lines; Swelling/ Edema; Synovitis

  MAUDE report 21357469 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Cellulitis; Skin Discoloration; Swelling/ Edema; Unspecified Infection

  MAUDE report 21034998 ↗