Persona® 42-5566-058-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024556720), received between Mar 29, 2022 and Jul 8, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED AN UNKNOWN FALL. THE PATIENT REPORTS PAIN AND STIFFNESS POST IMPLANTATION. THE PATIENT WAS PRESCRIBED AN ADDITIONAL COURSE OF PHYSICAL THERAPY WHICH HAS IMPROVED THE PATIENT¿S SYMPTOMS. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Fall; Pain

  MAUDE report 19697277 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS SEEN IN THE OFFICE ABOUT THREE YEARS POST IMPLANTATION AFTER SUBSEQUENT FALLS AND NOW EXPERIENCING PAIN AND A SIGNIFICANT EFFUSION. THE PATIENT HAS A FIVE DEGREE EXTENSOR LAG SECONDARY TO THE PAIN AND SWELLING AND AT THE OFFICE APPOINTMENT, AN ASPIRATION WAS PERFORMED. LIMITED BLOODY FLUID WAS COLLECTED AS IT WAS THOUGHT TO BE COAGULATED. ALL RADIOGRAPHIC IMAGING DISPLAYS IMPLANTS IN GOOD POSITION WITHOUT SIGNS OF GROSS FAILURE OR LOOSENING AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Fall; Hematoma; Joint effusion; Loss of Range of Motion; Pain

  MAUDE report 19566996 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AN INJECTION FOR PES BURSITIS APPROXIMATELY SEVENTEEN (17) MONTHS FOLLOWING A LEFT KNEE ARTHROPLASTY TO ADDRESS CONTINUOUS POST-OPERATIVE PAIN AND SWELLING. THE PATIENT'S PAIN RESOLVED AFTER THE INJECTION WAS ADMINISTERED, HOWEVER, THE PATIENT CONTINUED TO HAVE WORSENING MODERATE EFFUSION. INITIAL OPERATIVE NOTES NOTED THAT THE PARTIAL KNEE ARTHROPLASTY TRACKED WITHOUT COMPLICATION AND THE PATIENT'S RANGE OF MOTION WAS ZERO (0) TO ONE-HUNDRED FORTY (140) DEGREES AND STABLE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14517262 ↗
• InjuryMay 26, 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 SURGERY. SUBSEQUENTLY, THE PATIENT FELL AND REPORTS ONGOING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Pain

  MAUDE report 14516115 ↗
• InjuryMay 26, 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 SURGERY. SUBSEQUENTLY, THE PATIENT FELL AND REPORTS ONGOING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Pain

  MAUDE report 14516103 ↗
• InjuryMar 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT DEVELOPED STIFFNESS, DECREASED RANGE OF MOTION, AND SCAR TISSUE/ADHESIONS AND UNDERWENT MANIPULATION UNDER ANESTHESIA APPROXIMATELY THREE MONTHS AND ONE WEEK POST IMPLANTATION. AT TWO YEAR FOLLOW UP THE PATIENT HAS MILD PAIN AND STIFFNESS WITH NORMAL X-RAY, NO REVISION REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 13942716 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED COUGH, SHORTNESS OF BREATH, RIB PAIN, BACK PAIN, NAUSEA/VOMITING, AND DIARRHEA WHICH PROGRESSED TO DIFFICULTY BREATHING AND THE PATIENT WAS HOSPITALIZED APPROXIMATELY THREE WEEKS POST IMPLANTATION WITH PULMONARY EMBOLISM AND PNEUMONIA. THESE ISSUES WERE RESOLVED APPROXIMATELY SEVEN MONTHS LATER WITH MEDICAL TREATMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Embolism/Embolus; Pneumonia

  MAUDE report 13942569 ↗

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: