PERSONA® Vivacit-E® 42-5402-000-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00889024247680), received between Oct 20, 2020 and Jan 7, 2026 — classified as 40 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K121771, K172524); 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION TKR DUE TO PATELLA INSTABILITY AND MALTRACKING. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 23996337 ↗
• InjuryDec 4, 2025Positioning Failure; Positioning Failure

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

  Patient problems: Pain

  MAUDE report 23716027 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Joint Laxity

  MAUDE report 23392998 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANTATION OF A PRIMARY LEFT KNEE ARTHROPLASTY, THE PATIENT WAS REVISED OF THE PATELLA COMPONENT DUE TO INSTABILITY AND PAIN. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23097828 ↗
• MalfunctionJun 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING SURGERY, THE PERSONA PATELLA WAS OPENED A HAIR WAS FOUND EMBEDDED IN THE PATELLA. ANOTHER DEVICE WAS USED FOR THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335604 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PROGRESSIVE PERSISTENT PAIN AND WAS PRESCRIBED MEDICATION APPROXIMATELY TWO YEARS AND THREE MONTHS POST IMPLANTATION. THE PATIENT WAS PRESCRIBED MEDROL DOS PAK AND THE ISSUE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22131033 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE PATELLA DUE TO PAIN APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22015618 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED PAIN IN THE BACK OF LEFT KNEE APPROXIMATELY ON YEAR, NINE MONTHS POST IMPLANTATION AND WAS PRESCRIBED PHYSICAL THERAPY. REPORTED IMPROVING, AND REMAINS IMPLANTED. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: Pain

  MAUDE report 21980464 ↗
• InjuryMar 27, 2025Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE AND PATELLAR COMPONENTS APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information; Pain

  MAUDE report 21706689 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE POST IMPLANTATION DUE TO PAIN AND STIFFNESS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 20566541 ↗
• InjuryOct 15, 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: Thrombosis/Thrombus

  MAUDE report 20455899 ↗
• InjuryOct 9, 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: Pain

  MAUDE report 20407664 ↗
• InjuryJul 8, 2024Adverse 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 TWENTY MONTHS POST IMPLANTATION DUE TO PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19689432 ↗
• InjuryJun 27, 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: Loss of Range of Motion; Pain

  MAUDE report 19628368 ↗
• InjuryJun 12, 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: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain

  MAUDE report 19522103 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. PATIENT REPORTED A POPPING SENSATION WITH FEELING THE JOINT GAVE OUT. THEY NOTED THEIR LAST EPISODE THEY HEARD THE POP AND FELT THE IMPLANT MOVE OUT THEN POP INTO PLACE. THE PATIENT ALSO REPORTED HAVING PAIN AND DIFFICULTY AMBULATING. NO RECORDS WERE PROVIDED. THE PATIENT FOLLOWED UP WITH THEIR SURGEON, WHO ORDERED AN MRI FOR THEIR CONTINUED PAIN, DIFFICULTY AMBULATING, DECREASED RANGE OF MOTION, AND SUBLUXATION. A REVISION WAS PLANNED FOR THE NEAR FUTURE BUT WAS DELAYED DUE TO THE PATIENT'S MEDICAL HISTORY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Subluxation; Swelling/ Edema

  MAUDE report 19461965 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A REVISION 7 YEARS LATER DUE TO ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN OVER THE PES BURSA AND WAS INITIAL PRESCRIBED NSAIDS AND PHYSICAL THERAPY FOR PES ANSERINUS BURSITIS. THE PATIENT RECEIVED A CORTISONE INJECTION SIXTEEN MONTHS POST REVISION. ALL IMPLANTS REMAIN IN PLACE AND AT THE TWO-YEAR FOLLOW-UP, REPORTS NO PAIN.

  Patient problems: Bursitis; Pain

  MAUDE report 19139781 ↗
• InjuryApr 9, 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: Adhesion(s); Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 19070154 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18439669 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY SIXTEEN MONTHS POST-IMPLANTATION DUE TO PATELLA PAIN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 18124528 ↗
• InjuryOct 16, 2023Adverse 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: Unspecified Infection

  MAUDE report 17938425 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 6 WEEKS POST IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND ARTHROFIBROSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain

  MAUDE report 17879715 ↗
• InjuryAug 23, 2023Malposition of Device; Naturally Worn; Malposition of Device; Naturally Worn

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 17604657 ↗
• InjuryAug 9, 2023Adverse 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: Hyperresponsive to stimuli; Pain; Swelling/ Edema

  MAUDE report 17487919 ↗
• InjuryJun 13, 2023Adverse 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: Loss of Range of Motion

  MAUDE report 17119187 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771, K172524. One submission often covers many models, so check the product and lot details in each record.

• Z-1917-2016 · May 11, 2016 · Terminated
  Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
• Z-1266-2015 · Jan 28, 2015 · Terminated
  Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in eit