Persona® The Personalized Knee® OsseoTi® 42-5350-067-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024631915), received between Oct 15, 2024 and Sep 29, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Melted; Device Damaged Prior to Receipt by User

  It was reported that when the outer box of a tibial implant was opened, the inner portion appeared deformed, as if melted. There was no surgical delay. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931478 ↗
• MalfunctionDec 16, 2025Positioning Problem; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815651 ↗
• MalfunctionDec 10, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770299 ↗
• MalfunctionDec 5, 2025Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726955 ↗
• InjuryNov 6, 2025Adverse 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: Bone Fracture(s)

  MAUDE report 23486261 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM A STUDY THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ABOUT A YEAR LATER, THE PATIENT DEVELOPED TENDONITIS REQUIRING ADDITIONAL SURGERY TO THE OPERATIVE JOINT FOR IT BAND RELEASE AND SYMPTOMS ARE NOW REPORTEDLY RESOLVING. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Impingement; Tendinopathy

  MAUDE report 23294663 ↗
• MalfunctionOct 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING KNEE PAIN AND TIBIAL RADIOLUCENCY APPROXIMATELY TWELVE (12) WEEKS FOLLOWING RIGHT KNEE ARTHROPLASTY. NO REVISION HAS BEEN PLANNED TO DATE. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Radiolucent Lines

  MAUDE report 20455776 ↗