Persona® 42-5603-135-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887868250033), received between Feb 16, 2022 and Sep 17, 2024 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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: Bone Fracture(s); Fall; Pain; Swelling/ Edema

  MAUDE report 20238843 ↗
• 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: Bone Fracture(s); Fall; Pain; Swelling/ Edema

  MAUDE report 20238837 ↗
• 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: Bone Fracture(s); Fall; Pain; Swelling/ Edema

  MAUDE report 20238816 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED ADDITIONAL PHYSICAL THERAPY AND WAS PRESCRIBED DICLOFENAC AND CELEBREX FOR TREATMENT OF PES ANSERINUS BURSITIS, ILIOTIBIAL BAND TENDONITIS, PAIN, SWELLING, STIFFNESS, WEAKNESS AND INSTABILITY APPROXIMATELY TWO (2) MONTHS FOLLOWING LEFT KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS UPON IMPLANTATION OF DEVICES.

  Patient problems: Bursitis; Muscle Weakness/Atrophy; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 18825791 ↗
• InjuryApr 13, 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: Bursitis; Pain

  MAUDE report 16732426 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY WITH UNKNOWN PRODUCT. THE PATIENT WAS REVISED APPROXIMATELY 1.5 YEARS LATER DUE TO IMPLANT LOOSENING. AT THE 1 YEAR FOLLOW UP, THE PATIENT PRESENTED WITH LEFT LATERAL KNEE PAIN THAT RADIATES TO LOWER LEG. NARCOTICS WERE PRESCRIBED. AT THE 2 YEAR FOLLOW UP APPOINTMENT. A LARGE LEFT KNEE EFFUSION WAS PRESENT. LEFT KNEE ASPIRATION WAS COMPLETED IN THE OFFICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15978556 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 11 WEEKS POST IMPLANTATION, THE PATIENT DEVELOPED SWELLING, INFLAMMATION, AND PES BURSITIS OF THE RIGHT KNEE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH A CORTISONE INJECTION AND THE ISSUES RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 13568859 ↗
• 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 13548377 ↗
• 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 13546105 ↗

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: