Persona® 42-5420-075-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024562806), received between Jan 14, 2021 and Dec 22, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING CONTINUED PAIN AND STIFFNESS APPROXIMATELY FIVE (5) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 23864882 ↗
• InjuryNov 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23573813 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN TWO YEARS AND FOUR MONTHS POST IMPLANTATION. THE TIBIAL, STEM AND TIBIAL CONE IMPLANTS WERE REVISED FOR CAUSE, THE ARTICULAR SURFACE WAS ALSO REPLACED AS BEST PRACTICE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22282195 ↗
• 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 20235579 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN TO EXPERIENCE AN INCREASE IN PAIN APPROXIMATELY 8 MONTHS POST PROCEDURE. THE PATIENT WAS PRESCRIBED A MEDROL PACK AND AN ADDITIONAL COURSE OF PHYSICAL THERAPY. THE PAIN IMPROVED BUT RETURNED AROUND 2 WEEKS LATER WHERE IT WAS PRESENTED OVER THE LCL AND A GENICULAR BLOCK WAS RECOMMENDED. ALL RADIOGRAPHIC IMAGING DISPLAYS IMPLANTS IN GOOD POSITION WITHOUT GROSS FAILURE OR LOOSENING AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain

  MAUDE report 19567552 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT BEGAN TO HAVE KNEE PAIN AFTER AN UNKNOWN INJURY, APPROXIMATELY THREE YEARS POST IMPLANTATION. PATIENT WAS PRESCRIBED ANTI-INFLAMMATORIES, ICE, AND HOME EXERCISES PROGRAM FOR QUAD STRENGTHENING. ALL IMPLANTS REMAIN IN PLACE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19567032 ↗
• MalfunctionMar 25, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18975195 ↗
• 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 18825774 ↗
• InjuryAug 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17584615 ↗
• 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 OF PAIN AND SWELLING APPROXIMATELY SIX MONTHS POST- IMPLANTATION. THE ISSUES WERE NOTED TO BE RESOLVED AFTER ORAL STEROIDS AND ANTI INFLAMMATORY MEDICATION.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 13551513 ↗
• 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 13546108 ↗
• InjuryFeb 15, 2021Difficult to Insert; Off-Label Use; Difficult to Insert; Off-Label Use

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH PERSONA. THE SURGEON COULD NOT INSERT PERSONA MC SURFACE TO TIBIA BASE PLATE AND HE DISENGAGED THE SURFACE TO CLEAN SPACE BETWEEN THE SURFACE AND THE TIBIA BASE PLATE BY SALINE. AFTER THAT, HE TRIED TO INSERT THE SURFACE AGAIN BUT HE COULD NOT. SUBSEQUENTLY, PERSONA UC SURFACE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11327375 ↗
• InjuryJan 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant; No Information

  MAUDE report 11170172 ↗

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: