Persona® Partial Knee System 42-5580-006-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304808577), received between Jul 6, 2020 and Oct 30, 2025 — classified as 5 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (K161592); 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.

• InjuryOct 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT UNDERWENT A RIGHT KNEE TKA APPROXIMATELY TWO YEARS AGO. SUBSEQUENTLY THE PATIENT HAD A REVISION AFTER EXPERIENCING PAIN AND INFLAMMATION DUE TO A METAL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 23425747 ↗
• InjurySep 15, 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: Arthritis; Aseptic loosening; Cyst(s); Osteolysis

  MAUDE report 23057580 ↗
• InjuryMar 25, 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 KNEE ARTHROPLASTY REVISION TO ADDRESS INSTABILITY AND ASEPTIC LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS NEARLY THREE (3) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Fall; Pain

  MAUDE report 13901611 ↗
• InjuryDec 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO FRACTURING OF THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11045753 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT UNDERWENT A RIGHT KNEE TKA APPROXIMATELY TWO YEARS AGO. SUBSEQUENTLY THE PATIENT HAD A REVISION AFTER EXPERIENCING PAIN AND INFLAMMATION DUE TO A METAL ALLERGY.

  Patient problems: Inflammation; Pain; Reaction; Swelling

  MAUDE report 10233171 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161592. One submission often covers many models, so check the product and lot details in each record.

• Z-1238-2018 · Nov 29, 2017 · Terminated
  Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10
• Z-0349-2018 · Jul 5, 2017 · Terminated
  Persona Partial Knee System, Size 8, Finishing Guide