Persona® Partial Knee System 42-5380-007-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304812727), received between May 28, 2020 and Jun 30, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT UNI-COMPARTMENTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, SWELLING, INSTABILITY, AND VARUS LAXITY IN EXTENSION APPROXIMATELY 1.5 YEARS POST-OP AND UNDERWENT A REVISION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 22356949 ↗
• 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 22131793 ↗
• InjuryNov 27, 2024Adverse 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: Bone Fracture(s)

  MAUDE report 20798274 ↗
• InjuryApr 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND BONE SCAN DISPLAYED IMPLANT LOOSENING APPROXIMATELY ONE YEAR POST IMPLANTATION. NO REVISION IS PLANNED AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16776197 ↗
• InjuryOct 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 15544245 ↗
• InjuryJun 30, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND BONE SCAN DISPLAYED IMPLANT LOOSENING APPROXIMATELY ONE YEAR POST IMPLANTATION. NO REVISION IS PLANNED AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 14874088 ↗
• InjuryMay 28, 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: Inflammation; Pain; Reaction; Swelling

  MAUDE report 10096152 ↗

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