Persona® 42-5046-058-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024562547), received between Dec 17, 2020 and May 23, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K181947, K191625); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT REPORTED MODERATE PAIN TO THE KNEE WITH EXTREME PAIN STANDING UPRIGHT AND BENDING TO THE FLOOR DURING THE TWO YEARS FOLLOW UP. THE PATIENT HAS IMPROVED AS THE STUDY CONTINUED, ALL RADIOGRAPHIC IMAGING DISPLAYS NO SIGNIFICANT FINDINGS, AND ALL PRODUCTS REMAIN IMPLANTED.

  Patient problems: Pain

  MAUDE report 22077591 ↗
• InjuryJul 8, 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: Fall; Pain

  MAUDE report 19697251 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A REVISION 7 YEARS LATER DUE TO ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN OVER THE PES BURSA AND WAS INITIAL PRESCRIBED NSAIDS AND PHYSICAL THERAPY FOR PES ANSERINUS BURSITIS. THE PATIENT RECEIVED A CORTISONE INJECTION SIXTEEN MONTHS POST REVISION. ALL IMPLANTS REMAIN IN PLACE AND AT THE TWO-YEAR FOLLOW-UP, REPORTS NO PAIN.

  Patient problems: Bursitis; Pain

  MAUDE report 19139777 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE PROCEDURE AND APPROXIMATELY 1 YEAR POST-OP, WAS REVISED DUE TO INSTABILITY. THE PATIENT WAS REVISED TO A NEW SYSTEM AND THE SURGEON NOTED THAT THE IMPLANTS WERE WELL FIXED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 18538031 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY. SUBSEQUENTLY, THE PATIENT FELL AND REPORTS ONGOING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Pain

  MAUDE report 14515910 ↗
• InjuryMar 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT DEVELOPED STIFFNESS, DECREASED RANGE OF MOTION, AND SCAR TISSUE/ADHESIONS AND UNDERWENT MANIPULATION UNDER ANESTHESIA APPROXIMATELY THREE MONTHS AND ONE WEEK POST IMPLANTATION. AT TWO YEAR FOLLOW UP THE PATIENT HAS MILD PAIN AND STIFFNESS WITH NORMAL X-RAY, NO REVISION REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 13942683 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED COUGH, SHORTNESS OF BREATH, RIB PAIN, BACK PAIN, NAUSEA/VOMITING, AND DIARRHEA WHICH PROGRESSED TO DIFFICULTY BREATHING AND THE PATIENT WAS HOSPITALIZED APPROXIMATELY THREE WEEKS POST IMPLANTATION WITH PULMONARY EMBOLISM AND PNEUMONIA. THESE ISSUES WERE RESOLVED APPROXIMATELY SEVEN MONTHS LATER WITH MEDICAL TREATMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Embolism/Embolus; Pneumonia

  MAUDE report 13942560 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND INFLAMMATION IN KNEE EIGHT MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Inflammation; Pain

  MAUDE report 13548804 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A RIGHT UNILATERAL KNEE REPLACEMENT. APPROXIMATELY ONE MONTH POST IMPLANTATION, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND ARTHROFIBROSIS.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 11029574 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181947, K191625. One submission often covers many models, so check the product and lot details in each record.

• Z-2578-2026 · May 11, 2026 · Open, Classified
  Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: