Persona® Partial Knee System 42-5282-005-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00880304818231), received between Oct 15, 2019 and Sep 29, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 10 most recent of 10 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 50935673 ↗
• MalfunctionDec 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN INITIAL PARTIAL KNEE ARTHROPLASTY, FOREIGN MATERIAL RESEMBLING A HUMAN HAIR WAS OBSERVED UPON OPENING OF THE DEVICE PACKAGING. THE DEVICE WAS IMPLANTED HOWEVER THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830038 ↗
• 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 21634618 ↗
• MalfunctionApr 21, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE DID NOT INSERT INTO THE MATING COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16786379 ↗
• MalfunctionDec 13, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE DID NOT INSERT INTO THE MATING COMPONENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968929 ↗
• 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 12553837 ↗
• 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 11873453 ↗
• 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 10072487 ↗
• 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 9879978 ↗
• 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 9192380 ↗

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