Persona® Partial Knee System 42-5380-005-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00880304812697), received between Oct 15, 2019 and Sep 29, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Migration” (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 11 most recent of 11 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 50935675 ↗
• InjuryMar 18, 2025Adverse 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 SURGERY. AT THE ONE YEAR FOLLOW UP VISIT, THE PATIENT REPORTED ONGOING PAIN AND SWELLING. THE RIGHT KNEE WAS ASPIRATED AND AN ARTHROSCOPY WAS PERFORMED ON UNKNOWN DATES. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21634629 ↗
• InjuryApr 20, 2023Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE PROCEDURE. SUBSEQUENTLY, APPROXIMATELY 5 MONTHS POST PROCEDURE, THE PATIENT WAS REVISED DUE TO TIBIAL SUBSIDENCE. SURGEON IS OF THE OPINION THE SUBSIDENCE MAY BE DUE TO POSSIBLE PATIENT POOR BONE QUALITY RATHER THAN IMPLANT FAILURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16775749 ↗
• InjuryApr 22, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE HEMIARTHROPLASTY REVISION APPROXIMATELY FIVE (5) MONTHS POST-OPERATIVELY TO ADDRESS TIBIAL COMPONENT SUBSIDENCE AND PAIN. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED NO SIGNIFICANT SCARRING, NO DAMAGE TO THE ARTICULAR SURFACE AND THERE WERE NO PROBLEMS WITH THE LOCKING MECHANISM. THE TIBIAL AND FEMORAL COMPONENTS WERE REMOVED WITHOUT BONE LOSS AND THERE WAS NO NOTATION OF LOOSENING. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 14186801 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL PARTIAL RIGHT KNEE PROCEDURE. DURING THE TRIAL REDUCTION, THE PATIENT SUSTAINED AN ANTERIOR CRUCIATE LIGAMENT INJURY. THE PATIENT REMAINED IN THE HOSPITAL FOR THREE DAYS. AT THE TIME OF THIS REPORT, NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED AND THE FINAL OUTCOME IS UNKNOWN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Damage to Ligament(s); Inflammation; Pain; Swelling/ Edema

  MAUDE report 13283153 ↗
• 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 12553834 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING PAIN DURING POST-OP FOLLOW UP.

  Patient problems: Pain

  MAUDE report 11873074 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED WITH PPK; SUBSEQUENTLY ABOUT ONE WEEK AFTER THE PRIMARY OPERATION, THE PATIENT'S TIBIA BONE CRACKED FROM A PINHOLE MADE BY NEW TYPE CUT GUIDE. THE PATIENT BONE HAS BEEN OBSERVED. A REVISION IS NOT PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11783747 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REPORTED ONGOING PAIN ONE (1) YEAR FOLLOWING RIGHT KNEE ARTHROPLASTY AND WAS GIVEN COCODAMOL FOR TREATMENT OF PAIN. THE PATIENT LATER UNDERWENT AN ARTHROSCOPIC PROCEDURE APPROXIMATELY TWENTY (20) MONTHS POST-OPERATIVELY TO ADDRESS THE KNEE PAIN THAT HAD NOT YET RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 10072483 ↗
• 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 9193093 ↗
• 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 9192376 ↗

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