Persona® PPS® 42-5086-062-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024631298), received between Oct 21, 2024 and Nov 25, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Packaging 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 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: Ambulation or Postural Difficulties; Loss of Range of Motion; Scar Tissue

  MAUDE report 20770449 ↗
• MalfunctionOct 21, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT UPON OPENING THE FEMORAL COMPONENT, A HAIR WAS IDENTIFIED BETWEEN THE LAYERS OF STERILE PACKAGING. THE IMPLANT WAS STILL USED TO COMPLETE THE SURGERY AS THE HAIR WAS NOT WITHIN THE INNER STERILE PACKAGING AND DID NOT MAKE CONTACT WITH THE PRODUCT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493542 ↗