Persona® The Personalized Knee® 42-5099-040-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024632202), received between May 31, 2023 and Nov 3, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Mechanical Jam; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452220 ↗
• MalfunctionMay 28, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE FEMORAL SIZER WAS FOUND TO BE INACCURATE. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096980 ↗
• MalfunctionOct 30, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE SURGEON NOTICED MOTION IN TOP PORTION OF THE DEVICE WHILE SIZING THE FEMUR WITH DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE.HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566546 ↗
• MalfunctionJun 11, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515246 ↗
• MalfunctionJun 11, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515243 ↗
• MalfunctionJun 11, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS NOTED THAT WHEN THE NEW SIZER WAS GOING TO BE PLACED IN A KIT, THE ETCHING AND TICK MARKS WERE MIS-ALIGNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515241 ↗
• MalfunctionApr 26, 2024Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE POSTERIOR REFERENCING SIZER SEEMS A BIT TOO LOOSE WHEN USED ON THE FEMUR AND ISN¿T AS PRECISE AS IT SHOULD BE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO IMPACT ON THE PATIENT. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192530 ↗
• MalfunctionApr 18, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE SIZER WAS NO LONGER ABLE TO LOCK ON THE PREFERRED SETTING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140883 ↗
• MalfunctionOct 17, 2023Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951912 ↗
• MalfunctionMay 31, 2023Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032553 ↗