Persona® The Personalized Knee® OsseoTi® 42-5350-075-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024631946), received between May 3, 2023 and Sep 30, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947925 ↗
• MalfunctionDec 15, 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 23802831 ↗
• 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 22508532 ↗
• InjuryMay 8, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED A PATIENT BEGAN TO EXPERIENCE LIMITED RANGE OF MOTION AND STIFFNESS ABOUT ONE MONTH POST IMPLANTATION. PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA ABOUT ONE WEEK LATER WITH NO COMPLICATIONS. FOLLOWING THE MANIPULATION, THE PATIENT CONTINUED TO EXPERIENCE STIFFNESS AND LIMITED RANGE OF MOTION AND TWO WEEKS AFTER THE FIRST MUA A SECOND MANIPULATION WAS COMPLETED. IN THE MONTHS FOLLOWING, THE PATIENT PRESENTED WITH CONTINUED STIFFNESS. FIVE MONTHS AFTER THE SECOND MANIPULATION, THE PATIENT UNDERWENT AN ARTHROSCOPIC LYSIS OF ADHESIONS AND SYNOVECTOMY DUE TO ARTHROFIBROSIS. ALL IMPLANTS REMAIN IN PLACE AND THE EVENT IS IMPROVING. SUSPECTED TIBIAL OVERHANG IS NOTED IN SUPPLIED RECORDS.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21987439 ↗
• 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 20137485 ↗
• InjuryMay 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT WAS HOSPITALIZED TWO DAYS POST IMPLANTATION FOR PNEUMONIA, CLOSTRIDIOIDES DIFFICILE (C. DIFF) COLITIS, AND SEPSIS. TREATED WITH OXYGEN, ORAL VANCOMYCIN, IV CEFEPIME, ORAL FLAGYL, IV FLUIDS WERE ADMINISTERED. AFTER ADMISSION, THE PATIENT BEGAN DEVELOPING RECURRENT FEVERS WITH NO APPARENT CAUSE. A CT REVEALED A PULMONARY EMBOLISM AND SO THE PATIENT WAS STARTED ON IV HEPARIN. THE PATIENT'S OUTCOME HAS NOT RESOLVED AND IS ONGOING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pneumonia; Pulmonary Embolism

  MAUDE report 19415489 ↗
• MalfunctionMar 13, 2024Malposition of Device; Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895962 ↗
• MalfunctionMay 3, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT AN IMPLANT HAD A HAIR IN THE STERILE PACKAGE ON THE DEVICE. IT IS UNKNOWN AT THIS TIME IF HAIR CAME FROM ROOM OR PRIOR TO OPENING STERILE PACKAGE. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860292 ↗