Persona® Vivacit-E® 42-5228-007-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024555303), received between Sep 7, 2021 and Sep 30, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fracture

  Patient problems: Joint Laxity; Pain

  MAUDE report 50947301 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT¿S ARTICULAR SURFACE WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Arthrofibrosis; Insufficient Information

  MAUDE report 24291821 ↗
• InjuryJan 20, 2026Premature Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE POLYETHYLENE EXCHANGE APPROXIMATELY 20 MONTHS POST-IMPLANTATION DUE TO A DISENGAGED LOCKING SCREW IDENTIFIED ON RADIOGRAPH. THE TEAM WAS NOTIFIED FOLLOWING REVIEW OF AN X-RAY. INTRA-OPERATIVELY, ALL IMPLANTS WERE WELL FIXED. THE DISENGAGED SCREW AND THE CONSTRAINED CONDYLAR KNEE POLYETHYLENE INSERT WERE REMOVED, AND A CPS POLYETHYLENE INSERT WAS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24114530 ↗
• InjurySep 2, 2025Fracture; Fracture

  IT WAS REPORTED A PATIENT WAS REVISED APPROXIMATELY THREE YEARS AND FOUR MONTHS POST IMPLANTATION DUE TO INSTABILITY, INABILITY TO BEAR WEIGHT, AND LIMITED RANGE OF MOTION. THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY FOLLOWING A TRAUMATIC MOTOR VEHICLE ACCIDENT. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE INSTABILITY, INABILITY TO BEAR WEIGHT, AND LIMITED RANGE OF MOTION AND UNDERWENT A REVISION. DURING THE REVISION, THE POLYETHYLENE POST WAS FRACTURED, THE POLY WAS UPSIZED TO 20MM, ALL OTHER COMPONENTS WERE RETAINED, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. AT THE TWO-WEEK FOLLOW-UP, THE PATIENT WAS DOING WELL WITH MINIMAL PAIN.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Joint Laxity; Loss of Range of Motion

  MAUDE report 22936414 ↗
• InjuryMar 5, 2025Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE SHEARED IMPLANT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21525490 ↗
• 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 13568914 ↗
• InjuryOct 7, 2021Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT A RIGHT REVISION PROCEDURE SEVEN WEEKS POST IMPLANTATION DUE TO ARTICULAR SURFACE PROSTHESIS FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 12590459 ↗
• InjurySep 7, 2021Migration; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 12434152 ↗

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: