Persona® 42-5046-062-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024562691), received between Feb 16, 2022 and Jul 10, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 5 most recent of 5 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 22472018 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING UNKNOWN ONGOING CHRONIC PROBLEMS POST IMPLANTATION. 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: Insufficient Information; Pain

  MAUDE report 18451182 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD FRACTURED FEMUR UPON FINAL TRAILING POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 16860291 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ONSET INFLAMMATION AND ILIOTIBIAL BAND FRICTION APPROXIMATELY NINE MONTHS POST IMPLANTATION. THE ISSUES WERE NOTED TO BE RESOLVED AFTER ORAL STEROIDS, TOPICAL CREAM, AND FORMAL PHYSICAL THERAPY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 13551783 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT A LEFT REVISION PROCEDURE APPROXIMATELY TWO YEARS POST IMPLANTATION DUE SEVERE PAIN WITH TWISTING OR STAIRS AND MODERATE PAIN WITH PATELLAR TENDONITIS. THE PATIENT WAS TREATED WITH A TOPICAL ANTI-INFLAMMATORY CREAM AND THE OUTCOME WAS REPORTED AS RESOLVED ON THE SAME DAY. THE PRODUCTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Pain

  MAUDE report 13546106 ↗

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: