Persona® 42-5046-058-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024562684), received between Jun 29, 2022 and Jul 6, 2023 — classified as 2 injuries.

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

• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING AMBULATION DIFFICULTIES, PAIN, SWELLING, REDNESS IN KNEE POST IMPLANTATION. IT WAS FURTHER REPORTED THAT THE PATIENT'S PAIN LEVELS ARE OUT OF CONTROL, AND THEY CANNOT WALK UNASSISTED. THERE IS A FUTURE ARTHROSCOPY PLANNED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 17269619 ↗
• InjuryJun 29, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ILIOTIBIAL BAND TENDONITIS WITH PAIN AND DISCOMFORT APPROXIMATELY ONE (1) YEAR FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS TREATED CONSERVATIVELY WITH A CORTISONE INJECTION AND PRESCRIBED PHYSICAL THERAPY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Failure of Implant; Inflammation; Pain

  MAUDE report 14852038 ↗

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: