Persona® 42-5399-051-85Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304809086), received between Feb 17, 2020 and Feb 7, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Fracture; Material Fragmentation; Mechanical Jam; Fracture; Material Fragmentation; Mechanical Jam

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

  Patient problems: Foreign Body In Patient

  MAUDE report 16310917 ↗
• MalfunctionJun 27, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN INITIAL LEFT PARTIAL KNEE ARTHROPLASTY, A DRILL PIN BECAME JAMMED IN THE CUTTING GUIDE. THERE WAS NO SURGICAL DELAY OR PATIENT IMPACT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14832411 ↗
• MalfunctionMar 14, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN INITIAL LEFT KNEE PROCEDURE, THE DRILL PIN COLD WELDED INTO THE TIBIAL BLOCK. THE SURGEON WAS ABLE TO REMOVE THE CUTTING BLOCK WITHOUT ADDITIONAL INTERVENTION, SURGICAL DELAY, OR PATIENT IMPACT. THE PIN FRACTURED AFTER SURGERY WHEN TRYING TO REMOVE IT FROM THE BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758640 ↗
• MalfunctionNov 22, 2021Mechanical Jam; Mechanical Jam

  SEE H10 NARRATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856761 ↗
• MalfunctionMay 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT THIS EVENT OCCURRED DURING SURGERY. THE DEVICE FRACTURED AND THE PINS ARE DEFORMED WHICH AFFECTED THE PROCEDURE. NO KNOWN ADVERSE EVENT WAS REPORTED. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884517 ↗
• MalfunctionFeb 17, 2020Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, THE PIN WOULD NOT RELEASE FROM THE GUIDE. THE SURGERY WAS FINISHED WITH THE CORRECTION CUT BLOCK. NO KNOWN ADVERSE EVENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9716533 ↗