Persona® 42-5568-066-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024556935), received between Apr 1, 2022 and Jun 19, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 19567540 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A REVISION 7 MONTHS LATER DUE TO TIBIAL AND FEMORAL INSTABILITY. SUBSEQUENTLY, 6 MONTHS AFTER THE REVISION THE PATIENT WAS EXPERIENCING ANTERIOR KNEE PAIN AND FOUND RADIOLUCENCY ON RADIOGRAPHIC IMAGING. A FEW MONTHS LATER, THE PATIENT HAD AN EPISODE OF PAIN AND STIFFNESS AND CONTINUED TO DISPLAY RADIOLUCENCY AT THE 2 YEAR FOLLOW-UP. PATIENT REPORTS DISTAL THIGH PAIN WITH A POSSIBLE STRESS FRACTURE AND WAS TOLD TO WEAR A BRACE. AT THIS TIME, NO SURGICAL INTERVENTION HAS BEEN REPORTED AND ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Bone Fracture(s); Extraskeletal ossification; Pain; Radiolucent Lines

  MAUDE report 19536917 ↗
• 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 15978582 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Bone Fracture(s); Osteopenia/ Osteoporosis; Pain

  MAUDE report 13977985 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Bone Fracture(s); Osteopenia/ Osteoporosis; Pain

  MAUDE report 13977921 ↗

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: