PERSONA® Vivacit-E® 42-5224-007-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024243767), received between Apr 27, 2020 and Dec 29, 2025 — classified as 9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Off-Label Use; Inaccurate Information; Off-Label Use; Inaccurate Information

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON WAS PLANNING TO IMPLANT A CEMENTED CR FEMORAL COMPONENT WITH A MC POLY, HOWEVER, WHEN PUTTING THE IMPLANTS AWAY, THE NURSING TEAM REALIZED THEY HAD A PS POLY WITH A CR FEMUR. THE SURGEON THOUGHT THAT THE INNER STICKER PACKET MAY HAVE BEEN MISLABELED, HOWEVER, THE INVENTORY TEAM SUGGESTED THAT THAT WAS NOT THE CASE AS THEY WERE NOT MISSING A MC POLY AND WERE ONLY SHORT A PS POLY. NO SURGICAL INTERVENTION IS CURRENTLY PLANNED AS THE SURGEON BELIEVES HE IMPLANTED THE CORRECT MC POLY. THE SALES REP STATED THAT THEY THOUGHT THE BOXES WERE LABELED PROPERLY AND WAS NOT SURE IF THE INNER STICKER PACKET WAS MISLABELED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906034 ↗
• MalfunctionAug 25, 2025Off-Label Use; Inaccurate Information; Off-Label Use; Inaccurate Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882758 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

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

  MAUDE report 20793715 ↗
• InjuryApr 17, 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); Alteration in Body Temperature; Loss of Range of Motion; Scar Tissue; Swelling/ Edema; Unspecified Infection

  MAUDE report 19124539 ↗
• InjuryApr 17, 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: Inflammation; Swelling/ Edema

  MAUDE report 19124152 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA PROCEDURE TWO MONTHS POST IMPLANTATION DUE TO STIFFNESS AND LIMITED RANGE OF MOTION. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 17693005 ↗
• MalfunctionJul 19, 2023Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON ATTEMPTED TO INSERT THE ARTICULAR SURFACE, BUT IT DID NOT SEAT PROPERLY IN THE TIBIAL PLATE. AS A RESULT, THE SURGERY WAS COMPLETED WITH AN ALTERNATIVE ARTICULAR SURFACE IMPLANT. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17348873 ↗
• MalfunctionJul 11, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY, AND WAS DROPPED ON THE FLOOR DURING ATTEMPTED IMPLANTATION. 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 17298236 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO AND A HALF MONTHS POST-IMPLANTATION DUE TO STIFFNESS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

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

  MAUDE report 14348497 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT RIGHT TKA APPROXIMATELY 2 YEARS AGO. SUBSEQUENTLY, PATIENT HAD A POLY SWAP THREE MONTHS LATER FOR UNKNOWN REASONS. SALES REP STATES HE BELIEVES THE PATIENT HAS A HISTORY OF INSTABILITY AND LIGAMENT LAXITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12698879 ↗
• InjurySep 11, 2020Adverse 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; Scar Tissue; Swelling

  MAUDE report 10522047 ↗
• InjuryJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS LIGAMENTOUS INSTABILITY APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. THE ARTICULAR SURFACE WAS REMOVED AND REPLACED. IT WAS VERIFIED BY THE SURGEON THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 10179768 ↗
• InjuryApr 27, 2020Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

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

  Patient problems: No Information

  MAUDE report 10001525 ↗

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