Persona® Partial Knee System 42-5580-005-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304808485), received between Oct 8, 2020 and Jul 29, 2025 — classified as 7 injuries.

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

• InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22644106 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN LEFT INITIAL KNEE SURGERY. APPROXIMATELY 2.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO PAIN. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22131792 ↗
• InjuryMay 9, 2025Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE STUDY SITE REPORTED LOOSENING OF THE FEMORAL IMPLANT. THE EVENT IS DECLARED AS 'UNRELATED' TO THE DEVICE AND IS TOLERATED. THERE ARE NO CURRENT PLANS FOR REVISION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 21995224 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21927997 ↗
• InjuryOct 27, 2023Adverse 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: Pain

  MAUDE report 18021456 ↗
• InjuryOct 5, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT MEDIAL UNILATERAL KNEE ARTHROPLASTY. APPROXIMATELY 3 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, NUMBNESS, STIFFNESS, SWELLING, NOISE, AND DIFFICULTIES WITH MOBILITY.

  Patient problems: Loss of Range of Motion; Numbness; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15543684 ↗
• InjuryOct 8, 2020Adverse 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: No Code Available; Pain; Patient Problem/Medical Problem

  MAUDE report 10648374 ↗

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