PERSONA® Vivacit-E® 42-5402-000-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024247710), received between Oct 23, 2019 and Aug 5, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient has experienced moderate to severe pain and difficulty with activities approximately one (1) year following a right knee arthroplasty. Patient was recommended to modify activities and shoe wear and to pursue physical therapy, deep tissue massage and weight loss.Attempts have been made, however, no additional information is available.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 50148088 ↗
• MalfunctionFeb 27, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATELLAR IMPLANT PACKAGE WAS OPENED, AND THE PACKAGING WAS FOUND TO BE WARPED, SO THE IMPLANT WAS NOT USED AND WAS DISCARDED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468972 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 23766984 ↗
• InjuryJun 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22198238 ↗
• InjuryMar 12, 2025Adverse 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: Insufficient Information

  MAUDE report 21584733 ↗
• InjuryNov 14, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, AN OVERSIZED PATELLA WITH OVERHANG AND POTENTIAL LYSIS AROUND A PATELLA PEG APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20688376 ↗
• InjurySep 30, 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: Cellulitis; Inflammation

  MAUDE report 20333134 ↗
• 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 20226785 ↗
• InjuryJun 21, 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: Synovitis

  MAUDE report 19583544 ↗
• InjuryMay 28, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THIRTY FOUR MONTHS POST IMPLANTATION DUE TO PAIN AND IMPLANT LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19404086 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED DEEP VEIN THROMBOSIS AND WAS TREATED MEDICALLY 26 DAYS POST IMPLANTATION. THE COMPONENTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16215860 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT HAS SUBSEQUENTLY EXPERIENCED PAIN FOR OVER ONE YEAR POST-IMPLANTATION. INFECTION HAS BEEN RULED OUT AND THE MEDICAL TEAM CANNOT DETERMINE WHAT IS CAUSING THE PAIN. THE CURRENT OUTCOME OF THE PATIENT IS UNKNOWN AND FURTHER PLANNED MEDICAL INTERVENTION HAS NOT BEEN REPORTED. DUE DILIGENCE IS IN PROCESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15975744 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. LEGAL COUNSEL IS REPORTING PATIENT HAS FILED AN UNKNOWN ALLEGATION. PATIENT HAS NOT BEEN REVISED TO DATE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15950616 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 MONTHS LATER DUE TO STIFFNESS AND FIXED FLEXION DEFORMITY. THERE WERE NO CONTRIBUTING CONDITIONS REPORTED. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 15666644 ↗
• InjurySep 20, 2021Malposition of Device; Malposition of Device

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

  Patient problems: Insufficient Information

  MAUDE report 12497779 ↗
• MalfunctionOct 23, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING THE DISTRIBUTION PROCESS PACKAGING DAMAGE WITH STERILITY BARRIER POTENTIALLY COMPROMISED WAS IDENTIFIED. NO PATIENT OR SURGICAL INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 9225231 ↗

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