PERSONA® Vivacit-E® 42-5221-008-12 (UDI 00889024242418)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024242418), received between Aug 8, 2025 and Aug 8, 2025 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 09-JUN-2025, A JOURNAL ARTICLE WAS RETRIEVED FROM THE KNEE (2025) THAT REPORTED A PROSPECTIVE, NON-RANDOMIZED, MULTI-CENTER STUDY FROM THE USA. THE PURPOSE OF THE STUDY WAS TO INVESTIGATE THE EARLY RADIOGRAPHIC, SURVIVAL AND CLINICAL OUTCOMES OF A CEMENTLESS TANTALUM METAL TIBIAL IMPLANT WITH A MODULAR ANATOMIC COMPONENT. THE STUDY REVIEWED 148 IMPLANTS, FROM SEVEN RESEARCH SITES, BETWEEN 2018 AND 2020. A CEMENTLESS PERSONA TRABECULAR METAL TIBIA WAS IMPLANTED IN ALL PATIENTS WITHOUT THE USE OF AUTOGRAFT BONE PASTE SLURRY. WITH REGARD TO THE TIBIAL COMPONENT, 79 PATIENTS RECEIVED A MEDIAL CONGRUENT VIVACIT-E COMPONENT, 25 PATIENTS RECEIVED A POSTERIOR STABILIZED POLYETHYLENE COMPONENT, 25 PATIENTS RECEIVED A POSTERIOR STABILIZED VIVACIT-E COMPONENT, AND 19 PATIENTS RECEIVED AN ULTRA-CONGRUENT VIVACIT-E COMPONENT. THE PATELLA WAS RESURFACED IN 92 KNEES. THE INDICATION FOR SURGERY WAS ARTHRITIS, AVASCULAR NECROSIS OF THE FEMORAL CONDYLE, POST-TRAUMATIC LOSS OF JOINT CONFIGURATION, MODERATE DEFORMITY, AND/OR THE SALVAGE OF PREVIOUSLY FAILED SURGICAL ATTEMPTS THAT DID NOT INCLUDE PARTIAL OR FULL ARTHROPLASTY OF THE IPSILATERAL KNEE. THE STUDY POPULATION HAD A MEAN AGE OF 63.3 YEARS

  Patient problems: Crepitus; Pain; Tendinopathy

  MAUDE report 22748815 ↗