Persona® 42-5566-066-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024556744), received between Feb 22, 2022 and Jun 19, 2024 — classified as 5 injuries.

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.

• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN TO HAVE KNEE PAIN AFTER AN UNKNOWN INJURY, APPROXIMATELY THREE YEARS POST IMPLANTATION. PATIENT WAS PRESCRIBED ANTI-INFLAMMATORIES, ICE, AND HOME EXERCISES PROGRAM FOR QUAD STRENGTHENING. ALL IMPLANTS REMAIN IN PLACE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19566857 ↗
• InjuryJun 14, 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: Bone Fracture(s); Extraskeletal ossification; Pain; Radiolucent Lines

  MAUDE report 19536907 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A REVISION 7 MONTHS LATER DUE TO TIBIAL AND FEMORAL INSTABILITY. SUBSEQUENTLY, 6 MONTHS AFTER THE REVISION THE PATIENT WAS EXPERIENCING ANTERIOR KNEE PAIN AND FOUND RADIOLUCENCY ON RADIOGRAPHIC IMAGING. A FEW MONTHS LATER, THE PATIENT HAD AN EPISODE OF PAIN AND STIFFNESS AND CONTINUED TO DISPLAY RADIOLUCENCY AT THE 2 YEAR FOLLOW-UP. PATIENT REPORTS DISTAL THIGH PAIN WITH A POSSIBLE STRESS FRACTURE AND WAS TOLD TO WEAR A BRACE. AT THIS TIME, NO SURGICAL INTERVENTION HAS BEEN REPORTED AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Bone Fracture(s); Extraskeletal ossification; Pain; Radiolucent Lines

  MAUDE report 19536588 ↗
• 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 PREINCISIONAL 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; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 13576741 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT EXPERIENCED PAIN, STIFFNESS, SWELLING, INFLAMMATION, AND WOUND DRAINAGE. ATTEMPTS TO GATHER ADDITIONAL INFORMATION ARE UNDERWAY, HOWEVER NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 13576739 ↗

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: