Persona® PPS® 42-5086-068-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024631366), received between Apr 19, 2024 and Nov 20, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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.

• InjuryNov 20, 2025Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain

  MAUDE report 23604786 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 16 DAYS POST-OP, THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC FOR MILD REDNESS TO PROXIMAL INCISION AS A PROPHYLAXIS TREATMENT AND IT RESOLVED WITH NO FURTHER ALLEGATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erythema; Post Operative Wound Infection

  MAUDE report 21036279 ↗
• MalfunctionOct 9, 2024Difficult or Delayed Positioning; Difficult to Insert; Difficult or Delayed Positioning; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407744 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION, THE PATIENT EXHIBITED INADEQUATE FLEXION OF THE IMPLANTED JOINT. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED WITHOUT COMPLICATION AND THE PATIENT'S RANGE OF MOTION IMPROVED. ALL DEVICES REMAIN IMPLANTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 19143246 ↗