Persona® 42-5046-070-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024562608), received between Jun 7, 2021 and Oct 27, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Flaked” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Malposition of Device; Malposition of Device

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

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

  MAUDE report 23393091 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. APPROXIMATELY 8 MONTHS POST-OP, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY AS THE PATIENT HAD A SEVERE, PAINFUL SKIN REACTION DUE TO A NICKEL ALLERGY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 20460590 ↗
• InjurySep 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE A LOSS OF RANGE OF MOTION AND AN INFECTION WAS SUSPECTED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY WHERE LOOSENING WAS FOUND HOWEVER THE INFECTION RESULTS WERE INCONCLUSIVE. ALL COMPONENTS WERE REVISED WITHOUT COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Loss of Range of Motion; Unspecified Infection

  MAUDE report 20226653 ↗
• 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 MANIPULATION UNDER ANESTHESIA AND REVISION ONE YEAR ELEVEN MONTHS POST IMPLANTATION DUE TO ASEPTIC FAILURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND MANIPULATION UNDER ANESTHESIA TWO MONTHS LATER DUE TO SWELLING, LIMITED RANGE OF MOTION, STIFFNESS, ADHESIONS, AND SCAR TISSUE. ALL IMPLANTS REMAIN IN PLACE.

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

  MAUDE report 19139759 ↗
• InjuryApr 16, 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 19119179 ↗
• MalfunctionJun 7, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNKNOWN REVISION WHEN THE FEMORAL IMPLANT WAS OPENED THE TECH NOTICED AFTER REMOVING THE PLASTIC PLUG, THERE WAS SOMETHING FLAKING OFF THE BOSS OF THE IMPLANT. DURING INVESTIGATION, IT WAS DETERMINED THAT THE REPORTED DEBRIS IS NOT A RESULT OF FLAKING OF THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947674 ↗

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: