Persona® Partial Knee System 42-5580-004-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00880304808553), received between Oct 15, 2019 and Sep 29, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Unstable” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50935696 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT UNILATERAL KNEE ARTHROPLASTY. SUBSEQUENTLY 5 MONTHS POST-OP, THE PATIENT RECEIVED A STEROID INJECTION TO THE RIGHT KNEE FOR PES BURSITIS FOLLOWING AN INCIDENT OF PAIN AFTER BENDING DOWN TO GET INTO A PLANK POSITION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain

  MAUDE report 19351352 ↗
• 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 16775868 ↗
• 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 14874070 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT SUFFERED A MEDIAL TIBIAL PLATEAU FRACTURE UNDER THE TIBIA. THERE WERE NO CONTRIBUTING FACTORS RELATED TO THE EVENT. THE PATIENT HAD GOOD BONE QUALITY. THE FRACTURE HEALED, HOWEVER, THE PATIENT WAS REVISED APPROXIMATELY 3 MONTHS POST-IMPLANTATION DUE TO CONTINUED PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12553827 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN INITIAL RIGHT PARTIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A PULMONARY EMBOLISM AND WAS HOSPITALIZED OVERNIGHT APPROXIMATELY 3 MONTHS POST-IMPLANTATION. NO FURTHER COMPLICATIONS WERE NOTED. AT THE NEXT FOLLOW UP VISITS, THE PATIENT REPORTED SLIGHT PAIN, NO PROBLEMS, FULL RANGE OF MOTION, AND REMAINED VERY SATISFIED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 12540188 ↗
• InjurySep 9, 2021Unstable; Migration; Unstable; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, INSTABILITY, POLYETHYLENE DEGRADATION AND FEMORAL COMPONENT DISPLACEMENT APPROXIMATELY THREE YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain

  MAUDE report 12446405 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE IS RELATED TO ONGOING ISSUES PREVIOUSLY REPORTED ON 0001825034-2019-00602.

  Patient problems: Pain

  MAUDE report 9947761 ↗
• InjuryMar 25, 2020Unstable; Unstable

  IT WAS REPORTED THAT APPROXIMATELY 1 YEAR POST IMPLANTATION, THE PATIENT WAS TREATED FOR PAIN AND INSTABILITY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 9879974 ↗
• InjuryOct 15, 2019Unstable; Unstable

  IT WAS REPORTED THAT APPROXIMATELY 1 YEAR POST IMPLANTATION, THE PATIENT WAS TREATED FOR PAIN AND INSTABILITY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 9193090 ↗
• InjuryOct 15, 2019Unstable; Unstable

  IT WAS REPORTED THAT APPROXIMATELY 1 YEAR POST IMPLANTATION, THE PATIENT WAS TREATED FOR PAIN AND INSTABILITY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 9193085 ↗
• InjuryOct 15, 2019Adverse 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: Abscess; Wound Dehiscence

  MAUDE report 9192382 ↗

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