PERSONA® Vivacit-E® 42-5121-008-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024469334), received between Nov 2, 2023 and Nov 2, 2023 — 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.

• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, STIFFNESS, POPPING SENSATIONS, LIGAMENT LAXITY, INSTABILITY AND LIMITED ABILITY TO PERFORM DAILY ACTIVITIES APPROXIMATELY FIFTEEN (15) MONTHS POST-OPERATIVELY. THE ARTICULAR SURFACE AND FEMORAL COMPONENT WERE REVISED AND REPLACED AND A TIBIAL STEM ADDED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 WITH AT HOME THERAPY. REVISION OPERATIVE NOTES NOTED THE PATIENT'S PAIN BEGAN APPROXIMATELY SIX (6) MONTHS PRIOR, LIMITING DAILY ACTIVITY, AND THE PATIENT WAS ALSO EXPERIENCING INSTABILITY. DURING THE PROCEDURE, SEVERE VARUS-VALGUS LAXITY AND HYPEREXTENSION WERE NOTED. THE FEMORAL COMPONENT WAS IN GOOD ALIGNMENT AND REMOVED WITHOUT DIFFICULTY. SCLEROTIC AND NON-VIABLE BONE REQUIRED REMOVAL FROM THE FEMUR PRIOR TO PLACING THE NEW FEMORAL COMPONENT. A SEQUENTIALLY LARGER ARTICULAR SURFACE WAS USED TO ACHIEVE STABILITY AND THE TIBIAL BASEPLATE WAS PUNCHED TO ACCOMMODATE THE TIBIAL STEM. NO INTRAOPERATIVE COMPLICATIONS WERE IDENTIFIED.

  Patient problems: Ambulation or Postural Difficulties; Hyperextension; Joint Laxity; Necrosis; Pain

  MAUDE report 18061912 ↗