Persona® 42-5566-070-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024556829), received between Feb 18, 2022 and Dec 22, 2025 — classified as 5 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 5 most recent of 5 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 23864739 ↗
• 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 21909473 ↗
• 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 19468840 ↗
• 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 19468832 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO INSTABILITY. SUBSEQUENTLY, AT EIGHT MONTHS POST OP, THE PATIENT EXPERIENCED A SEVERE EFFUSION. ONE YEAR AND FIVE MONTHS LATER, THE PATIENT REPORTED SEVERE STIFFNESS AND PAIN. THE FINAL OUTCOME HAS BEEN REPORTED AS TOLERATED WITH NO MEDICAL INTERVENTION. THE PRODUCTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

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

  MAUDE report 13559984 ↗

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: