PERSONA® Vivacit-E® 42-5221-009-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024468511), received between May 9, 2022 and Mar 24, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erythema; Post Operative Wound Infection

  MAUDE report 24679929 ↗
• InjuryDec 4, 2025Pitted; Pitted

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

  Patient problems: Insufficient Information

  MAUDE report 23716340 ↗
• InjuryMay 7, 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: Ambulation or Postural Difficulties

  MAUDE report 19260239 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18614144 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT HAS SUBSEQUENTLY EXPERIENCED PAIN FOR OVER ONE YEAR POST-IMPLANTATION. INFECTION HAS BEEN RULED OUT AND THE MEDICAL TEAM CANNOT DETERMINE WHAT IS CAUSING THE PAIN. THE CURRENT OUTCOME OF THE PATIENT IS UNKNOWN AND FURTHER PLANNED MEDICAL INTERVENTION HAS NOT BEEN REPORTED. DUE DILIGENCE IS IN PROCESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15976772 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 MONTHS LATER DUE TO STIFFNESS AND FIXED FLEXION DEFORMITY. THERE WERE NO CONTRIBUTING CONDITIONS REPORTED. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 15666629 ↗
• InjuryJun 16, 2022Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. APPROXIMATELY ONE YEAR POST IMPLANTATION, THE PATIENT PRESENTED WITH CLICKING IN THE KNEE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO ARTICULAR SURFACE DISSOCIATION DUE TO LATERAL LAXITY. THE POLYETHYLENE COMPONENT WAS REVISED WITHOUT COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 14711837 ↗
• MalfunctionMay 9, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO INSERT THE ARTICULAR SURFACE. ANOTHER ARTICULAR SURFACE WAS USED. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338316 ↗