PERSONA® Vivacit-E® 42-5224-007-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024243750), received between Sep 23, 2020 and Oct 31, 2025 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Joint Dislocation

  MAUDE report 23435804 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA (MUA) APPROXIMATELY ONE YEAR TWO AND A HALF MONTHS POST IMPLANTATION. DURING THE PROCEDURE A LARGE AMOUNT OF SCAR TISSUE WAS EXCISED, FOLLOWING THE MUA THE KNEE FLEXED TO 120 AND HAD GREAT ROM WITHOUT IMPINGEMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 22293520 ↗
• MalfunctionMay 2, 2025Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950914 ↗
• MalfunctionMar 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ARTICULAR SURFACE DID NOT MATE WITH THE TIBIAL PLATE. THE OPERATION WAS COMPLETED WITH A DIFFERENT ARTICULAR SURFACE. THIS RESULTED IN A 5¿10-MINUTE SURGICAL DELAY. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559861 ↗
• InjuryJan 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE POLYETHYLENE FRACTURE APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21055963 ↗
• InjuryJun 4, 2024Noise, Audible; Noise, Audible

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19459296 ↗
• MalfunctionApr 16, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO MATE THE ARTICULAR SURFACE WITH THE TIBIAL COMPONENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115376 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 4.5 YEARS POST IMPLANTATION DUE TO INSTABILITY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 18998145 ↗
• InjuryNov 1, 2023Difficult to Insert; Dent in Material; Difficult to Insert; Dent in Material

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, THE MATING SLOT ON THE FRONT OF THE TIBIAL BASEPLATE BROKE WHILE ENGAGING THE ARTICULAR SURFACE VIA PERSONA ARTICULAR SURFACE INSERTER. THE ARTICULAR SURFACE FAILED TO ENGAGE IN AN OPTIMAL POSITION. IT WAS STUCK AND SURGEON STRUGGLED TO REMOVE IT OUT, RESULTING IN A DENT AND SCRATCH ON THE ARTICULAR SURFACE. THEREFORE, A NEW ARTICULAR SURFACE WAS OPENED AS PER REQUEST. THE BROKEN TIBIAL BASEPLATE COMPONENT WAS ALREADY CEMENTED INTO THE TIBIA SO IT REMAINED IMPLANTED. THE SURGICAL DELAY WAS APPROXIMATELY 20 MINUTES TO REMOVE THE STUCK ARTICULAR SURFACE AND TO PUT IN A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048825 ↗
• MalfunctionOct 31, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT COMPLAINED OF PAIN, SWELLING, LIMITED EXTENSION, SEVERE LIMP, AND CHRONIC QUADRICEPS WEAKNESS. THE SURGEON SUSPECTED A QUADRICEPS TENDON TEAR. APPROXIMATELY ONE YEAR, SIX MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION WHERE SIGNIFICANT SCAR TISSUE WAS ENCOUNTERED DUE TO PATELLA BAJA BUT ALL PATELLA AND QUADRICEPS TENDONS WERE FOUND INTACT. THE FEMORAL, TIBIA, AND POLY WERE REVISED WITH COMPETITOR PRODUCTS. THE PATELLA WAS NOT REVISED. THE PATIENT IS ALLEGING HER COMPONENTS WERE TOO LARGE.

  Patient problems: Ambulation or Postural Difficulties; Joint effusion; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18040574 ↗
• MalfunctionJun 15, 2023Difficult to Insert; Dent in Material; Difficult to Insert; Dent in Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135153 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS, WOUND DEHISCENCE AND LIMITED FLEXION IN KNEE TWO MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 14238005 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY APPROXIMATELY 13 MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ON 12 MONTHS LATER DUE TO PERSISTENT PAIN FOR ONE YEAR. DURING THE PROCEDURE THERE WAS SOME MID FLEXION LAXITY WHICH THE IT BAND WAS TRANSECTED. THE POLY WAS EXCHANGED WITHOUT DIFFICULTY.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 12799648 ↗
• MalfunctionAug 20, 2021Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE SURGEON FAILED TO INSERT AN ARTICULAR SURFACE TO THE TIBIAL COMPONENT. SEVERAL ATTEMPTS WERE MADE AND HE CONFIRMED THAT THERE WAS NO CEMENT OR THIRD PARTICLES BETWEEN THE ARTICULAR SURFACE AND TIBIAL COMPONENT. SUBSEQUENTLY, A BACKUP WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348470 ↗
• InjurySep 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Bacterial Infection; Hematoma; Loss of Range of Motion; Necrosis; Tissue Damage; Wound Dehiscence

  MAUDE report 10573013 ↗

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