Persona® Trabecular Metal® 42-5450-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024560666), received between Mar 29, 2022 and Jan 2, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND STIFFNESS APPROXIMATELY SIX (6) MONTHS FOLLOWING KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 23944135 ↗
• InjuryNov 17, 2025Malposition of Device; Malposition of Device

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

  Patient problems: Ambulation or Postural Difficulties; Crepitus; Numbness; Pain; Swelling/ Edema

  MAUDE report 23567836 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN APPROXIMATELY TWO (2) YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. THE PATIENT WAS INSTRUCTED TO CONTINUE OVER-THE-COUNTER PAIN-RELIEVERS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 21650724 ↗
• InjurySep 17, 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: Bursitis; Pain

  MAUDE report 20235537 ↗
• InjurySep 17, 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: Bursitis; Pain

  MAUDE report 20235534 ↗
• InjuryMar 18, 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: Hematoma; Joint effusion

  MAUDE report 18922639 ↗
• InjuryMar 13, 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: Fall; Inflammation; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 18895467 ↗
• InjuryJul 1, 2022Unstable; Migration; Unstable; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY PROCEDURE. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN, CREPITUS AND INSTABILITY. APPROXIMATELY TWO MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY. DURING THE SURGERY, A TIBIAL CORTEX FRACTURE WAS NOTED WHICH RESULTED IN SUBSIDENCE AND MINIMAL FIXATION OF THE TIBIAL COMPONENTS. THE TIBIAL BASEPLATE WAS ALSO NOTED TO HAVE DETACHED FROM THE TIBIAL STEM COMPONENT. AFFECTED COMPONENTS WERE REVISED WITHOUT REPORTED COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Failure of Implant; Joint Laxity; Osteopenia/ Osteoporosis; Pain

  MAUDE report 14886669 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND TENDERNESS OF THE PES ANSERINUS AND ILIOTIBIAL TRACT REQUIRING A CORTISONE INJECTION TWO YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Bursitis; Loss of Range of Motion; Pain

  MAUDE report 14582659 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED COUGH, SHORTNESS OF BREATH, RIB PAIN, BACK PAIN, NAUSEA/VOMITING, AND DIARRHEA WHICH PROGRESSED TO DIFFICULTY BREATHING AND THE PATIENT WAS HOSPITALIZED APPROXIMATELY THREE WEEKS POST IMPLANTATION WITH PULMONARY EMBOLISM AND PNEUMONIA. THESE ISSUES WERE RESOLVED APPROXIMATELY SEVEN MONTHS LATER WITH MEDICAL TREATMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Embolism/Embolus; Pneumonia

  MAUDE report 13942638 ↗

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: