PERSONA® Vivacit-E® 42-5121-003-11 (UDI 00889024235496)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024235496), received between Jan 24, 2022 and Jan 24, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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.

• InjuryJan 24, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY 14 MONTHS AGO. SUBSEQUENTLY, PATIENT HAD NO ISSUES IMMEDIATE POST OP BUT STARTED TO EXPERIENCE SWELLING AND STIFFNESS/TIGHTNESS SHORTLY AFTER. PATIENT HAD DIFFICULTY WALKING, STANDING, GETTING UP AND DOWN FROM SITTING POSITION. PATIENT WAS ABLE TO WALK UP TO ONE MILE. PATIENT UNDERWENT AN ASPIRATION TO REMOVE FLUID APPROXIMATELY 6 MONTHS AGO AND GOT NO RELIEF. APPROXIMATELY 3 MONTHS AGO SYMPTOMS STARTED TO GET WORSE; PATIENT WAS NOW EXPERIENCING PAIN AND CAN'T STAND FOR MORE THAN 10 MIN, CAN'T GET UP AND DOWN, CAN'T BEND KNEE, CAN'T WALK ANY DISTANCE WITHOUT PAIN. PATIENT UNDERWENT SECOND ASPIRATION LAST MONTH AND FLUID WAS SENT FOR TESTING FOR INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 13337693 ↗