Persona® 42-5046-058-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024562530), received between Feb 17, 2022 and Dec 27, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2024Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, ERYTHEMA, SWELLING, FEMORAL LOOSENING AND PERIPROSTHETIC, MEDIAL FEMORAL CONDYLE FRACTURE APPROXIMATELY FOUR YEARS POST IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: Bone Fracture(s); Erythema; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 21027265 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS PAIN, INSTABILITY, SWELLING AND EFFUSIONS APPROXIMATELY THREE (3) YEARS FOLLOWING THE PATIENT'S LAST KNEE PROCEDURE. DURING THE REVISION, SIGNIFICANT SCAR TISSUE WAS IDENTIFIED. THE ARTICULAR SURFACE WAS EXCHANGED FOR A LARGER SIZE AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED THAT THE PATIENT WAS BEING REVISED FOR INCREASING GLOBAL INSTABILITY OVER THE PREVIOUS SIX (6) TO NINE (9) MONTHS. UPON EXAMINATION, THE PATIENT HAD ABOUT FIVE (5) DEGREES OF RECURVATUM AND SIGNIFICANT INSTABILITY AT TERMINAL EXTENSION WITH ABOUT ONE (1) CENTIMETER OF CORONAL PLANE INSTABILITY. DURING THE PROCEDURE, SIGNIFICANT SCAR AND FIBROTIC TISSUE WAS DEBRIDED. ALL IMPLANTS WERE EXAMINED AND APPEARED STABLE AND THE ARTICULAR SURFACE WAS REPLACED WITH A LARGER SIZE WITH NO INTRAOPERATIVE COMPLICATIONS NOTED.

  Patient problems: Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18948833 ↗
• InjuryOct 16, 2023Adverse 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 LATER, 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 17942148 ↗
• InjuryOct 16, 2023Adverse 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 LATER, 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 17942142 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED MODERATE L PES ANSERINE BURSITIS APPROXIMATELY EIGHT MONTHS POST IMPLANTATION. THE PATIENT WAS GIVEN CORTISONE INJECTIONS AND THE ISSUE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 13548316 ↗

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: