Persona® 42-5568-070-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024556942), received between Dec 15, 2022 and Dec 22, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING CONTINUED PAIN AND STIFFNESS APPROXIMATELY FIVE (5) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Crepitus; Loss of Range of Motion; Pain

  MAUDE report 23864718 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED AS THIS EVENT IS NOT REPORTABLE.

  Patient problems: Fever; Joint effusion; Pain; Unspecified Infection

  MAUDE report 21909458 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED AS THIS EVENT IS NOT REPORTABLE.

  Patient problems: Fever; Joint effusion; Pain; Unspecified Infection

  MAUDE report 21909439 ↗
• InjurySep 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE A LOSS OF RANGE OF MOTION AND AN INFECTION WAS SUSPECTED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY WHERE LOOSENING WAS FOUND HOWEVER THE INFECTION RESULTS WERE INCONCLUSIVE. ALL COMPONENTS WERE REVISED WITHOUT COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Loss of Range of Motion; Unspecified Infection

  MAUDE report 20226661 ↗
• 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 19468835 ↗
• InjuryApr 16, 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: Fall; Pain

  MAUDE report 19119242 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  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: Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15988254 ↗

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: