Persona® 42-5046-062-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024562707), received between Nov 28, 2022 and Mar 28, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Unstable” (1 report).

1 other recall cover devices cleared under the same FDA submission (K181947, K191625); they may or may not involve this specific model.

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 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A HEMATOMA EVACUATED APPROXIMATELY TWO WEEKS POST PROCEDURE. A SIGNIFICANT HEMATOMA WAS NOTED, EVACUATED, AND A DRAIN PLACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

  Patient problems: Hematoma

  MAUDE report 21720034 ↗
• InjurySep 27, 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: Pain; Swelling/ Edema

  MAUDE report 20321356 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO (2) FALLS APPROXIMATELY SEVENTEEN (17) MONTHS AND FORTY (40) MONTHS FOLLOWING A RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS PRESCRIBED ANTI-INFLAMMATORIES AND REHABILITATION WAS RECOMMENDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Fall; Pain

  MAUDE report 19721697 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT RIGHT KNEE A TWO STAGE REVISION FOR INFECTION. SUBSEQUENTLY, APPROXIMATELY 7 MONTHS LATER THE PATIENT BEGAN TO HAVE INTERMITTENT PAIN AND SWELLING AND 2 YEARS FIVE MONTHS REPORTED AN INCREASE IN PAIN AND WAS PRESCRIBED PHYSICAL THERAPY. ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19139728 ↗
• InjuryJan 5, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING UNKNOWN ONGOING CHRONIC PROBLEMS POST IMPLANTATION ON THE RIGHT KNEE. THE PATIENT ALLEGES TO BE MEETING WITH A SURGEON FOR FURTHER CARE; HOWEVER, NO FURTHER INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Fall; Insufficient Information; Pain

  MAUDE report 18452187 ↗
• InjuryJul 11, 2023Adverse 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: Damage to Ligament(s)

  MAUDE report 17301482 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, BURSITIS AND TENDONITIS FOUR MONTHS POST IMPLANTATION DUE TO A FALL. RADIOGRAPHICALLY, IMPLANTS REMAIN INTACT, IN STABLE POSITION, AND WITH NO EVIDENCE OF LOOSENING OR WEAR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Fall; Numbness; Pain

  MAUDE report 15868529 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, BURSITIS AND TENDONITIS FOUR MONTHS POST IMPLANTATION DUE TO A FALL. RADIOGRAPHICALLY, IMPLANTS REMAIN INTACT, IN STABLE POSITION, AND WITH NO EVIDENCE OF LOOSENING OR WEAR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. HOWEVER; NO MORE IS AVAILABLE.

  Patient problems: Fall; Numbness; Pain

  MAUDE report 15868470 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181947, K191625. One submission often covers many models, so check the product and lot details in each record.

• Z-2578-2026 · May 11, 2026 · Open, Classified
  Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: