Persona® Trabecular Metal® 42-5450-005-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024560673), received between Feb 16, 2022 and Dec 27, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 21027299 ↗
• 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 20321380 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING ALLERGY TO METAL EIGHT MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17844515 ↗
• InjuryApr 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST-IMPLANTATION, THE PATIENT REPORTS PERSISTENT PAIN. RADIOLOGY RESULTS REVEAL INCREASED RADIOLUCENCY CONCERNING FOR LOOSENING OF THE TIBIA AND A STABLE PERIPROSTHETIC FRACTURE AT THE LATERAL FEMORAL CONDYLE. DUE TO THE BONE LOSS FROM TWO PRIOR REVISIONS, THE PATIENT DOES NOT WANT TO PURSUE ANOTHER REVISION AND WILL BE TREATED CONSERVATIVELY AT THIS TIME.

  Patient problems: Osteopenia/ Osteoporosis; Pain

  MAUDE report 13977817 ↗
• 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 13551424 ↗
• 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 13546110 ↗

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: