PERSONA® Vivacit-E® 42-5402-000-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00889024247703), received between Oct 23, 2019 and Dec 18, 2025 — classified as 30 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A CORTICOSTEROID INJECTION TO ADDRESS PAIN, SWELLING AND STIFFNESS APPROXIMATELY ONE (1) YEAR FOLLOWING RIGHT KNEE ARTHROPLASTY. HOWEVER, THE PATIENT CONTINUES TO EXPERIENCE PAIN AND HAS BEEN REFERRED FOR GENICULAR NERVE BLOCKS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23843993 ↗
• InjuryNov 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Pain; Swelling/ Edema

  MAUDE report 23584831 ↗
• InjuryOct 16, 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: Joint Laxity; Pain

  MAUDE report 23316331 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN TO EXPERIENCE LIMITED RANGE OF MOTION AND STIFFNESS ABOUT ONE MONTH POST IMPLANTATION. PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA ABOUT ONE WEEK LATER WITH NO COMPLICATIONS. FOLLOWING THE MANIPULATION, THE PATIENT CONTINUED TO EXPERIENCE STIFFNESS AND LIMITED RANGE OF MOTION AND TWO WEEKS AFTER THE FIRST MUA, A SECOND MANIPULATION WAS COMPLETED. IN THE MONTHS FOLLOWING, THE PATIENT PRESENTED WITH CONTINUED STIFFNESS. FIVE MONTHS AFTER THE SECOND MANIPULATION, THE PATIENT UNDERWENT AN ARTHROSCOPIC LYSIS OF ADHESIONS AND SYNOVECTOMY DUE TO ARTHROFIBROSIS. ALL IMPLANTS REMAIN IN PLACE AND THE EVENT IS IMPROVING. SUSPECTED TIBIAL OVERHANG IS NOTED IN SUPPLIED RECORDS.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 23094176 ↗
• InjurySep 16, 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: Bone Fracture(s)

  MAUDE report 23061908 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO KNEE RETINACULUM TEAR. THE PATELLA IMPLANT WAS EXCHANGED WITHOUT REPORTED COMPLICATION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Damage to Ligament(s); Pain

  MAUDE report 22806495 ↗
• InjuryJul 30, 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: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Pain; Weight Changes

  MAUDE report 22664433 ↗
• InjuryJun 18, 2025Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR YEARS TWO AND A HALF MONTHS POST IMPLANTATION DUE TO ASEPTIC LOOSENING. DURING THE REVISION THE PATELLA WAS FOUND TO BE GROSSLY LOOSE, THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE SLIGHTLY MOBILE AND ASEPTIC LOOSENING WAS CONFIRMED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema; Tendinopathy

  MAUDE report 22285738 ↗
• InjuryApr 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT A PATELLECTOMY PROCEDURE THREE MONTHS POST IMPLANTATION DUE TO DISLOCATION OF PATELLA. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Bursitis; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 21756140 ↗
• InjuryMar 27, 2025Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND TWO MONTHS POST IMPLANTATION DUE TO PATELLAR LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 21710999 ↗
• InjuryNov 19, 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 20724894 ↗
• InjuryOct 29, 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. APPROXIMATELY 2 MONTHS LATER, THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO LACK OF FLEXION AND STIFFNESS.

  Patient problems: Loss of Range of Motion

  MAUDE report 20560125 ↗
• InjuryOct 24, 2024Adverse 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 10 MONTHS POST IMPLANTATION DUE TO PAIN, SWELLING, AND INSTABILITY. DURING THE REVISION, SCAR TISSUE WAS DEBRIDED AND A MANIPULATION UNDER ANESTHESIA WAS PERFORMED, AND THE COMPONENTS WERE NOTED TO BE WELL FIXED. ALL IMPLANTS WERE REPLACED WITHOUT COMPLICATIONS.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20521519 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TEN (10) WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. THE ARTICULAR SURFACE, FEMORAL COMPONENT, AND PATELLAR IMPLANT WERE EXCHANGED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 20128578 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS APPROXIMATELY SIX (6) DAYS FOLLOWING RIGHT KNEE ARTHROPLASTY AND REQUIRED ANTICOAGULATION THERAPY. REPORTEDLY, THE PATIENT HAS SINCE IMPROVED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED DURING THE INITIAL PROCEDURE. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19819177 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO (2) YEARS AND ONE (1) MONTH POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE LIMITED RANGE OF MOTION AND WAS UNABLE TO BEND THE IMPLANTED KNEE PAST 90 DEGREES AND USE STAIRS. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY. THE TIBIAL COMPONENT, ARTICULAR SURFACE, AND IMPLANTED PATELLA WERE REPLACED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 19658260 ↗
• InjuryJun 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE REVISION 2 YEARS POST IMPLANTATION FOR PAIN IN LEFT KNEE. SUSPECTED PATELLA LOOSENING WHICH WAS CORRECTLY DIAGNOSED. REPLACED PATELLA WITH NEW CEMENTED PATELLA.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19478103 ↗
• MalfunctionMay 7, 2024Contamination; Contamination

  IT WAS REPORTED THE IMPLANT SEEMED TO HAVE A SHINY/GREASY FILM ON THE BACK OF THE IMPLANT. ONCE WE TRIED TO IMPLANT INTO CEMENT IT WOULDN¿T HOLD INTO THE CEMENT. A DIFFERENT PATELLA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY OR HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261543 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN EXPERIENCING RESTRICTED RANGE OF MOTION, PERSISTENT PAIN, WALKING DIFFICULTIES, SWELLING AND DIFFICULTY PERFORMING DAILY ACTIVITIES APPROXIMATELY SEVEN MONTHS POST IMPLANTATION. BETWEEN RADIOGRAPHIC IMAGING AND ASSESSMENT, PATELLAR BAJA, ABNORMAL PATELLAR TRACKING, AND ABNORMAL PATELLAR HEIGHT WAS FOUND. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY AND WAS REFERRED TO NEUROSURGERY FOR A POTENTIAL GENICULATE BLOCK.

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

  MAUDE report 18310784 ↗
• InjuryAug 8, 2023Loosening 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: Failure of Implant

  MAUDE report 17481784 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA TWO MONTHS POST IMPLANTATION DUE TO ARTHROFIBROSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 17171115 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT INITIAL KNEE REPLACEMENT. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS. IT WAS NOTED AS RESOLVED 2 WEEKS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Ankylosis; Discomfort

  MAUDE report 16863174 ↗
• MalfunctionMar 27, 2023Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620936 ↗
• InjuryDec 13, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED PATIENT UNDERWENT ARTHROSCOPIC SYNOVECTOMY POST IMPLANTATION DUE TO PATELLAR CLUNK SYNDROME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Scar Tissue

  MAUDE report 15968896 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD SUBCUTANEOUS ABSCESS ONE MONTH POST IMPLANTATION. CLEANING WAS PERFORMED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Abscess

  MAUDE report 15967711 ↗

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