PERSONA® Vivacit-E® 42-5124-007-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024237247), received between Apr 12, 2022 and Dec 9, 2025 — classified as 13 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K121771); 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 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: Fluid Discharge; Impaired Healing; Muscle/Tendon Damage; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 23759802 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22903311 ↗
• InjuryJul 3, 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 LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY EIGHT (8) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO STIFFNESS OF THE IMPLANTED JOINT. THE FEMORAL COMPONENT, STEM AND ARTICULAR SURFACE WERE EXCHANGED WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Muscular Rigidity

  MAUDE report 22395283 ↗
• MalfunctionJun 2, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ARTICULAR SURFACE AND TIBIAL TRAY WOULD NOT ASSEMBLE. THE SURGEON TRIED TO INSERT THE LINER AND LOCK WITH AN INSERT GUN, BUT THE INSERT WOULD NOT LOCK DOWN. THE SURGEON WASHED AND CLEANED UP BEFORE INSERTING THE LINER AGAIN. THERE WAS NO TISSUE OR CEMENT IN THE TIBIA OR BLOCKING THE INSERT FROM GOING IN BUT WAS STILL UNABLE TO LOCK DOWN THE INSERT. AS A LAST RESORT, THE SURGEON TRIED TO PUNCH THE INSERT IN WITH A TIBIA PUNCH WITH INWARDS AND DOWNWARDS DIRECTION, AND THERE WAS STILL A BIG GAP BETWEEN THE INSERT AND TIBIA. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123437 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3007963827.

  Patient problems: Muscular Rigidity

  MAUDE report 21413706 ↗
• MalfunctionDec 31, 2024Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT AN ARTICULAR SURFACE WOULD NOT ASSEMBLE WITH THE TIBIAL IMPLANT. ANOTHER ARTICULAR SURFACE WAS USED AS THE FIRST ONE WOULD NOT FIT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048541 ↗
• InjuryDec 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; Skin Discoloration; Swelling/ Edema; Unspecified Infection

  MAUDE report 21035007 ↗
• 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 20128571 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO INFECTION. THE TIBIAL INSERT WAS REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 20050484 ↗
• InjuryJun 25, 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; Scar Tissue

  MAUDE report 19607675 ↗
• 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 19583085 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIFTEEN MONTHS POST IMPLANTATION DUE TO PAIN AND INSTABILITY. DURING THE REVISION, THE SURGEON NOTED THAT THE DISTAL FEMORAL REFRESHER CUT OF 5MM WAS CONSISTENT WITH A DIAGNOSIS OF FLEXION INSTABILITY. THE FEMORAL COMPONENT AND ART SURFACE WERE REPLACED WHICH RESOLVED THE COMPLICATION, AND THE TIBIAL AND PATELLAR COMPONENTS REMAINED INTACT AND WELL-FIXED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19359501 ↗
• MalfunctionApr 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, AS THE SURGEON PLACED THE TIBIAL INSERT INTO THE TIBIAL TRAY USING AN INSERTER, THE TIBIAL TRAY CRACKED AND SMALL CHIP BROKE FROM THE TRAY. THE TIBIAL TRAY AND INSERT WERE REMOVED AND ADDITIONAL IMPLANTS WERE USED TO COMPLETE THE PROCEDURE. IT WAS LATER DETERMINED THAT THE EXPLANTED TIBIAL INSERT ALSO HAD A SMALL FRACTURE AND WAS NOT SEATED COMPLETELY ON THE TIBIAL TRAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191639 ↗
• MalfunctionApr 2, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A INITIAL TOTAL KNEE ARTHROPLASTY, THE SURGEON COULD NOT GET THE TIBIAL INSERT TO SEAT ON THE TIBIAL TRAY. THE PROCEDURE WAS COMPLETED USING ANOTHER TIBIAL INSERT THAT WAS AVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020047 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 7 DAYS POST IMPLANTATION, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PATIENT WAS ADMITTED FOR PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE, ELEVATED TROPONINS, AND ACUTE MYOCARDIAL INJURY. THE PATIENT WAS PLACED ON ADDITIONAL ANTICOAGULANTS AND OXYGEN AND DISCHARGED 3 DAYS LATER. APPROXIMATELY 2 WEEKS LATER, THE PATIENT WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS OF THE LEFT CALF. THE PATIENT IS TAKING ELIQUIS. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: Cardiac Enzyme Elevation; Hypoxia; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 15971233 ↗
• InjuryMay 6, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3.5 YEARS POST IMPLANTATION DUE TO PAIN, SWELLING, AND INSTABILITY. DURING THE SURGERY, IT WAS NOTED THAT THE PATELLAR COMPONENT HAD INCOMPLETE COVERAGE AND THERE WAS A SMALL AREA OF NECROSIS ON THE CENTER OF THE PATELLA. THE ARTICULAR SURFACE AND PATELLA WERE EXCHANGED AND THE SURGERY WAS COMPLETE WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 14310400 ↗
• InjuryApr 12, 2022Appropriate Device Problem Term/Code Not Available; Noise, Audible; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO PAIN WITH ACTIVITIES, CLICKING, AND LIMITED EXTENSION. DURING THE REVISION, SIGNIFICANT SCARRING AND HETEROTROPHIC BONE FORMATION WAS DEBRIDED. A NEW ARTICULAR SURFACE WAS PLACED WITHOUT COMPLICATION.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 14084766 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771. 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