Persona® 42-5420-067-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024562783), received between Feb 17, 2022 and Jul 10, 2025 — classified as 6 injuries.

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

• InjuryJul 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY THAT UNDERWENT A TOTAL KNEE PROCEDURE. SUBSEQUENTLY, TWO (2) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION, THE PATIENT REPORTED SEVERE PAIN AND A CONCERN OF WEAKNESS. ONGOING TENDINITIS/BURSITIS AND MILD EFFUSION WERE ALSO NOTED ON EXAM. ON THE NEXT FOLLOW-UP SIX (6) MONTHS LATER, RADIOGRAPHIC IMAGING DISPLAYED POSSIBLE LOOSENING AND BONE LOSS. THE PATIENT WISHES TO MANAGE THESE SYMPTOMS CONSERVATIVELY WITH HOME CARE AND OBSERVATION AT THIS TIME. ALL COMPONENTS REMAIN IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Bursitis; Joint effusion; Muscle Weakness/Atrophy; Osteopenia/ Osteoporosis; Pain; Tendinopathy

  MAUDE report 22472140 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, ERYTHEMA, SWELLING, FEMORAL LOOSENING AND PERIPROSTHETIC, MEDIAL FEMORAL CONDYLE FRACTURE APPROXIMATELY FOUR YEARS POST IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 21027295 ↗
• InjuryOct 9, 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: Ambulation or Postural Difficulties; Muscle/Tendon Damage; Pain; Synovitis

  MAUDE report 17894292 ↗
• InjuryMay 16, 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: Hypersensitivity/Allergic reaction

  MAUDE report 16938319 ↗
• InjuryJul 1, 2022Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  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 14886655 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED MODERATE L PES ANSERINE BURSITIS APPROXIMATELY EIGHT MONTHS POST IMPLANTATION. THE PATIENT WAS GIVEN CORTISONE INJECTIONS AND THE ISSUE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 13548365 ↗

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: