Persona® 42-5046-062-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024562554), received between Mar 18, 2022 and Mar 14, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 18901924 ↗
• InjuryMay 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Pain; Radiolucent Lines

  MAUDE report 16947984 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON UNKNOWN DATE DUE TO UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 13869599 ↗
• InjuryMar 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND POSSIBLE LOOSENING APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY. INITIAL OPERATIVE NOTES NOTED THE PATIENT WAS REVISED DUE TO INFECTION AND ADDITIONAL ANTIBIOTICS WERE ADMINISTERED IN THE BONE CEMENT. THE SURGEON NOTED THAT THE EXTRA ANTIBIOTICS MAY RESULT IN EARLY LOOSENING. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. REVISION OPERATIVE NOTES REPORTED THAT THE PATIENT WAS BEING REVISED FOR PAIN AND POTENTIAL LOOSENING. THE PATELLA WAS IN GOOD POSITION AND NOT LOOSE, SO THE SURGEON DID NOT REMOVE IT TO MAINTAIN BONE STOCK AT THE PATELLA. THE ARTICULAR SURFACE, FEMORAL AND TIBIAL COMPONENTS WERE REMOVED. NO NOTES WERE MADE ON THE CONDITION OF THE FEMORAL AND TIBIAL COMPONENTS. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13805911 ↗

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: