Persona® 42-5420-079-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024562813), received between Feb 21, 2022 and Jun 5, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE IMPLANTS AND REPORTED PAIN. THE IMPLANTS WERE FOUND TO BE LOOSE BUT WELL-ADHERED TO THE CEMENT MANTLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain

  MAUDE report 19468928 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ASPIRATION, ARTHROCENTESIS AND TRIAMCINOLONE ACETONIDE INJECTIONS TO ADDRESS PAIN, SYNOVITIS, LOSS OF RANGE OF MOTION, JOINT EFFUSION AND SWELLING APPROXIMATELY SIX MONTHS FOLLOWING LEFT KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18901932 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEVELOPED A DVT WITHIN THE LEFT LOWER LEG SEVEN DAYS AFTER THE PROCEDURE. THE DVT WAS RESOLVED WITH ELIQUIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 18701786 ↗
• InjuryDec 15, 2022Adverse 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 SURGERY. SUBSEQUENTLY, THE PATIENT HAD SWELLING IN THE LEFT KNEE RESULTING IN A LEFT KNEE ASPIRATION APPROXIMATELY 2.5 YEARS LATER. NO FURTHER COMPLICATIONS OR RESULTS WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15988235 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS EXPERIENCING MILD SWELLING, STIFFNESS AND PES ANSERINE TENDERNESS APPROXIMATELY 3 MONTHS POST IMPLANTATION. MILD BLOODY DRAINAGE AND PERIINCISIONAL DRAINAGE WAS ALSO NOTED. PATIENT WAS TREATED WITH VOLTAREN TOPICAL GEL AND PHYSICAL THERAPY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 13576815 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE PAIN AND CREPITATION CONSISTENT WITH ARTHROFIBROSIS APPROXIMATELY SIXTEEN MONTHS POST-IMPLANTATION. THE PATIENT WAS SCHEDULED FOR AN ARTHROSCOPY AND DEBRIDEMENT BUT IT IS UNKNOWN IF IT HAS OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fibrosis; Pain

  MAUDE report 13567589 ↗

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: