PERSONA® Vivacit-E® 42-5124-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024237087), received between Nov 20, 2019 and Aug 4, 2026 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133321 ↗
• MalfunctionNov 21, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING PROCEDURE, THE ARTICULAR SURFACE DID NOT ASSEMBLE WITH MATING IMPLANT. 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 20745337 ↗
• MalfunctionNov 16, 2023Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT AN ARTICULAR SURFACE WOULD NOT MATE WITH THE TIBIAL PLATE. THE SURGEON CONFIRMED THAT THERE WAS NO FOREIGN SUBSTANCE INTERFERENCE BETWEEN THE MATING AREA. AS A RESULT, THE OPERATION WAS COMPLETED WITH ANOTHER ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148694 ↗
• MalfunctionAug 16, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE DID NOT FIT TO MATING COMPONENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15236408 ↗
• MalfunctionNov 3, 2021Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746428 ↗
• InjuryNov 1, 2021Material Erosion; Material Erosion

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 12729414 ↗
• InjuryNov 20, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND ELEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO PAIN, TIBIAL AND FEMORAL LOOSENING, AND A FRACTURED TIBIAL COMPONENT. AT THE DIAGNOSIS, THE TIBIA BASE WAS SUBSIDED AND THE COMPONENT WAS LOOSENING. LOOSENING OF THE FEMUR COMPONENT WAS ALSO CONFIRMED. AT THE REVISION PROCEDURE, WEAR WAS SEEN ON THE EXPLANTED ARTICULAR SURFACE AND THE PLASTIC CAP FOR THE EXPLANTED TIBIA COMPONENT WAS FRACTURED. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Pain

  MAUDE report 9350042 ↗

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