Persona® 00-5901-035-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024563193), received between Aug 2, 2022 and Feb 9, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Fracture; Damaged Thread

  IT WAS REPORTED METAL THREAD CAME OFF OF SCREW WHEN SCREWING INTO 4-IN-1. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293932 ↗
• MalfunctionDec 1, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRODUCT HAD DAMAGED STERILE PACKAGING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681616 ↗
• MalfunctionMay 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HEX DRIVER BROKE DURING SURGERY. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003176 ↗
• InjuryAug 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE HEX HEAD SCREW FRACTURED DURING INSERTION. THE SURGEON ATTEMPTED TO REMOVE IT, BUT PART OF THE TIP REMAINED INSIDE THE BODY. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19917585 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A REVISION 7 YEARS LATER DUE TO ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN OVER THE PES BURSA AND WAS INITIAL PRESCRIBED NSAIDS AND PHYSICAL THERAPY FOR PES ANSERINUS BURSITIS. THE PATIENT RECEIVED A CORTISONE INJECTION SIXTEEN MONTHS POST REVISION. ALL IMPLANTS REMAIN IN PLACE AND AT THE TWO-YEAR FOLLOW-UP, REPORTS NO PAIN.

  Patient problems: Bursitis; Pain

  MAUDE report 19139798 ↗
• MalfunctionAug 2, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT THERE WERE METAL SHAVINGS RELATED TO THE FIXATION OF THE CUTTING BLOCK AND SCREWS OR SAW BLADE. ALL METAL SHAVINGS WERE RETRIEVED FROM THE PATIENT'S WOUND. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145868 ↗
• MalfunctionAug 2, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT THERE WERE METAL SHAVINGS RELATED TO THE FIXATION OF THE CUTTING BLOCK AND SCREWS OR SAW BLADE. ALL METAL SHAVINGS WERE RETRIEVED FROM THE PATIENT'S WOUND. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145867 ↗