Persona® 42-5046-066-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024562585), received between Feb 17, 2022 and May 29, 2025 — 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.

• InjuryMay 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE SURGERY AND APPROXIMATELY 2 MONTHS POST-OP, THE PATIENT WAS REVISED DUE TO PAIN AND FEMORAL LOOSENING. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22107778 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIRTEEN DAYS POST-OPERATION THE PATIENT EXPERIENCED HEMARTHROSIS AND DEVELOPED A LARGE EFFUSION. 60ML OF BLOODY SYNOVIAL FLUID WAS ASPIRATED WITHOUT COMPLICATION.

  Patient problems: Hematoma; Joint effusion

  MAUDE report 18922617 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST-IMPLANTATION, THE PATIENT REPORTS PERSISTENT PAIN. RADIOLOGY RESULTS REVEAL INCREASED RADIOLUCENCY CONCERNING FOR LOOSENING OF THE TIBIA AND A STABLE PERIPROSTHETIC FRACTURE AT THE LATERAL FEMORAL CONDYLE. DUE TO THE BONE LOSS FROM TWO PRIOR REVISIONS, THE PATIENT DOES NOT WANT TO PURSUE ANOTHER REVISION AND WILL BE TREATED CONSERVATIVELY AT THIS TIME.

  Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis; Pain

  MAUDE report 13977689 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE DAYS POST IMPLANTATION, THE PATIENT HAD PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF PAIN. DURING EVALUATION, THE SURGEON NOTED HEMARTHROSIS OF THE REPLACED JOINT. PATIENT WAS TREATED WITH PHYSICAL THERAPY AND A NARCOTIC PAIN MEDICATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 13568781 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ARTHROSCOPY OF RIGHT KNEE WITH LYSIS OF ADHESIONS APPROXIMATELY TWO MONTHS POST IMPLANTATION. PHYSICAL THERAPIST NOTICED PASSIVE PATELLAR MOBILIZATION AND RANGE OF MOTION WAS LIMITED IN RIGHT KNEE POST KNEE REPLACEMENT. STIFFNESS AND ARTHROFIBROSIS OF RIGHT KNEE WERE NOTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

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

  MAUDE report 13550416 ↗

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: