Persona® PPS® 42-5086-068-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024631359), received between Sep 4, 2024 and Jul 30, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A STUDY THAT APPROXIMATELY 1 MONTH POST IMPLANTATION OF A LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS DIAGNOSED WITH CELLULITIS AND WAS PRESCRIBED ANTIBIOTICS, AS WELL AS UNDERWENT A WOUND DEBRIDEMENT, IRRIGATION, AND WOUND CARE. THE PATIENT WAS REPORTED AS FULLY HEALED APPROXIMATELY 6 WEEKS LATER. DEVICES REMAIN IMPLANTED. ATTEMPTS WERE MADE AND ALL AVAILABLE INFORMATION WAS PROVIDED.

  Patient problems: Cellulitis

  MAUDE report 22668484 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. AT THE ONE YEAR FOLLOW UP, THE PATIENT REPORTED SEVERE PAIN AND DIFFICULTY WITH DAILY ACTIVITIES. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 22508455 ↗
• InjuryMay 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE FEMORAL IMPLANT. THE PATIENT WAS REVISED WITHOUT ISSUE.

  Patient problems: Aseptic loosening

  MAUDE report 22073656 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 2.5 MONTHS POSTOP, THE PATIENT EXPERIENCED THREE SYNCOPAL EPISODES AND RADIOGRAPHIC IMAGING CONFIRMED A PULMONARY EMBOLISM. THE PULMONARY EMBOLISM IS RESOLVING WITH PRESCRIBED MEDICATION AND ALL IMPLANTS REMAIN IN PLACE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pulmonary Embolism; Syncope/Fainting

  MAUDE report 20137497 ↗