Persona® 42-5420-075-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024562899), received between Feb 17, 2022 and Sep 16, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 20226694 ↗
• MalfunctionAug 13, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL BILATERAL KNEE SURGERY. DURING THE SURGERY, A RIGHT TIBIA AND POLY WERE INSERTED INTO THE PATIENT'S LEFT SIDE. THE RIGHT SIDED IMPLANTS WERE CORRECTLY LABELED. THERE WAS A 30 MINUTE SURGICAL DELAY TO DISCUSS THE ERROR WITH THE SURGEON, HOWEVER, THE IMPLANTS REMAIN IMPLANTED. THE PATIENT HAS NOT HAD ANY ISSUES TO DATE AND HAS MOBILIZED WITH GOOD EFFECT. A REVISION SURGERY IS NOT PLANNED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973175 ↗
• InjuryJul 11, 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); Fall; Pain

  MAUDE report 19719575 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A TOTAL KNEE REVISION 4 YEARS POST IMPLANTATION DUE TO INFECTION. AN ADDITIONAL REVISION OF THE PATELLAR COMPONENT TOOK PLACE APPROXIMATELY 18 MONTHS POST PROCEDURE DUE TO ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT REPORTED AN ONSET OF ANTERIOR KNEE PAIN THAT BEGAN 8 MONTHS AFTER THE PATELLA REVISION.

  Patient problems: Ambulation or Postural Difficulties; Joint Contracture; Pain

  MAUDE report 19119380 ↗
• MalfunctionJun 13, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. A IMPACTOR WAS USED TO SEAT THE TIBIAL INSERT INTO THE TRAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117371 ↗
• InjuryAug 9, 2022Migration; Migration

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE YEARS POST IMPLANTATION DUE TO THE TIBIAL BASEPLATE INTERNALLY ROTATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15192819 ↗
• 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 13550453 ↗

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: