PERSONA® Vivacit-E® 42-5121-003-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024468894), received between Dec 5, 2022 and May 14, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, STIFFNESS, DECREASED RANGE OF MOTION, KNEE HEAVINESS AND POSSIBLE FEMORAL LOOSENING APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. THE KNEE ACHIEVED GOOD RANGE OF MOTION AND EXCELLENT STABILITY AT THE TIME OF PROCEDURE COMPLETION. REVISION OPERATIVE NOTES NOTED EXTENSIVE SCAR TISSUE THROUGHOUT THE KNEE. THE FEMORAL COMPONENT WAS INSPECTED BUT DID NOT REVEAL ANY EVIDENCE OF OBVIOUS LOOSENING. THE TIBIAL AND PATELLAR COMPONENTS WERE WELL-FIXED AND LEFT INTACT. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Arthrofibrosis; Inflammation; Loss of Range of Motion; Pain

  MAUDE report 25167514 ↗
• InjuryDec 23, 2025Adverse 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: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 23876261 ↗
• MalfunctionDec 4, 2025Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719961 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A KNEE LINER EXCHANGE DUE TO INSTABILITY IN EXTENSION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 23554995 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND DIFFICULTY AMBULATING UNABLE TO BEAR WEIGHT POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20127303 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18439716 ↗
• MalfunctionMay 3, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE DIDN'T NEATLY MATE WITH THE TIBIAL PLATE, ALTHOUGH SEVERAL ATTEMPTS WERE MADE BY THE SURGEON. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859667 ↗
• InjuryDec 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY OF THE TIBIAL COMPONENT AND ARTICULAR SURFACE. THE REASON FOR REVISION SURGERY IS UNKNOWN. DUE DILIGENCE IS IN PROCESS FOR THIS COMPLAINT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15914814 ↗