Persona® 42-5046-070-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024562592), received between Mar 24, 2021 and Dec 22, 2025 — classified as 9 injuries.

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 9 most recent of 9 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 23864540 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PRIMARY KNEE IMPLANTED, FOLLOWED BY A FULL REVISION SIXTEEN MONTHS LATER. THIS WAS FOLLOWED BY A BEARING REPLACEMENT NINE MONTHS POST REVISION. A THIRD REVISION WAS PERFORMED ELEVEN MONTHS AFTER THE PREVIOUS WITH THE ARTICULAR SURFACE REPLACED DUE TO FLEXION INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 22771361 ↗
• InjuryJun 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE IMPLANTS AND REPORTED PAIN. THE IMPLANTS WERE FOUND TO BE LOOSE BUT WELL-ADHERED TO THE CEMENT MANTLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain

  MAUDE report 19468919 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE SURGERY. SUBSEQUENTLY, THE PATIENT HAD SWELLING IN THE LEFT KNEE RESULTING IN A LEFT KNEE ASPIRATION APPROXIMATELY 2.5 YEARS LATER. NO FURTHER COMPLICATIONS OR RESULTS WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15988245 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN APPROXIMATELY 18 MONTHS POST IMPLANTATION. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 15410858 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION KNEE SURGERY AND APPROXIMATELY 1 YEAR LATER, THE PATIENT PRESENTED WITH INCREASED PAIN AND LIMITED FLEXION. LABS AND ASPIRATIONS WERE NOT INDICATIVE OF INFECTION, BUT THE PATIENT¿S INFLAMMATORY MARKERS WERE ELEVATED. THE PATIENT WAS RETURNED TO THE OPERATING ROOM APPROXIMATELY 2 WEEKS LATER FOR AN OPEN LYSIS OF ADHESIONS, POLY EXCHANGE, EXTENSIVE SCAR TISSUE DEBRIDEMENT, LATERAL RELEASE, AND MANIPULATION. NO PURULENCE OR SIGNS OF INFECTION WERE NOTED DURING THE REVISION. THE POLY WAS EXCHANGED WITHOUT COMPLICATION, AND THE PATIENT WAS ADMITTED FOR PROPHYLACTIC IV ANTIBIOTIC THERAPY PENDING CULTURE RESULTS. UPON FOLLOW UP, ALL CULTURES WERE NEGATIVE FOR BACTERIAL GROWTH, BUT HISTOPATHOLOGY REVEALED ACUTE INFLAMMATION. THE PATIENT REPORTED FEELING BETTER THAN PRIOR TO THE PROCEDURE, AND LABS SHOWED IMPROVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Adhesion(s); Inflammation; Loss of Range of Motion; Pain; Scar Tissue; Subclinical Infection

  MAUDE report 13801384 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE PAIN AND CREPITATION CONSISTENT WITH ARTHROFIBROSIS APPROXIMATELY SIXTEEN MONTHS POST-IMPLANTATION. THE PATIENT WAS SCHEDULED FOR AN ARTHROSCOPY AND DEBRIDEMENT BUT IT IS UNKNOWN IF IT HAS OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fibrosis; Pain

  MAUDE report 13567574 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO INSTABILITY. SUBSEQUENTLY, AT EIGHT MONTHS POST OP, THE PATIENT EXPERIENCED A SEVERE EFFUSION. ONE YEAR AND FIVE MONTHS LATER, THE PATIENT REPORTED SEVERE STIFFNESS AND PAIN. THE FINAL OUTCOME HAS BEEN REPORTED AS TOLERATED WITH NO MEDICAL INTERVENTION. THE PRODUCTS REMAIN IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Bacterial Infection; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 13559934 ↗
• InjuryMar 24, 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

  MAUDE report 11563024 ↗

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: