Persona® Partial Knee System 42-5580-003-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00880304808461), received between Sep 11, 2020 and Aug 19, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported from a clinical study that the patient experienced moderate to severe knee pain and stiffness following an initial left partial knee arthroplasty. This was mentioned at follow-up visits through approximately five years post-implantation, symptoms were managed with acetaminophen and nonsteroidal anti-inflammatory drugs. The implants remained in place without further intervention. Attempts have been made and no further information has been provided.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 50332428 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported in a clinical study that at the two-year follow-up visit a patient reported experiencing increased pain and dissatisfaction. Home strengthening exercises were recommended as well as over the counter medication for pain. All implants remain intact, and no further information has been provided at this time. Attempts to obtain additional information have been made; however, no more information is available at this time.

  Patient problems: Pain

  MAUDE report 50174757 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY. APPROXIMATELY 2 YEARS AND 8 MONTHS POST IMPLANTATION, BILATERAL KNEE PAIN WAS REPORTED, AND A CORTISONE INJECTION WAS ADMINISTERED TO THE STUDY KNEE. ALL PRODUCTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22372707 ↗
• 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 22356895 ↗
• InjuryFeb 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE MONTH POST IMPLANTATION DUE TO ARTICULAR SURFACE DISLOCATION. THE ARTICULAR SURFACE DISLOCATION OCCURRED AFTER THE PATIENT FELL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 21333469 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TEN MONTHS POST IMPLANTATION DUE TO ONGOING PAIN AND PATIENT COMORBIDITIES AFTER GARDENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 16775588 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TEN MONTHS POST IMPLANTATION DUE TO PAIN AND DECREASED DAILY ACTIVITIES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 14469654 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, SWELLING AND TIBIAL OSTEOLYSIS APPROXIMATELY FIFTEEN (15) MONTHS POST-OPERATIVELY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES REPORTED REMOVAL OF IMPLANTS WITHOUT BONE LOSS WITH NO LOOSENING IDENTIFIED. NEW COMPONENTS WERE IMPLANTED AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 11585849 ↗
• InjuryFeb 5, 2021Unstable; Noise, Audible; Unstable; Noise, Audible

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

  Patient problems: Pain; Swelling

  MAUDE report 11285671 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, SWELLING AND TIBIAL OSTEOLYSIS APPROXIMATELY FIFTEEN (15) MONTHS POST-OPERATIVELY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES REPORTED REMOVAL OF IMPLANTS WITHOUT BONE LOSS WITH NO LOOSENING IDENTIFIED. NEW COMPONENTS WERE IMPLANTED AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling

  MAUDE report 11276189 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT UNILATERAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A FALL THREE WEEKS POST OP. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO DIFFICULTY AMBULATING, DECREASE IN ACTIVITY OF DAILY LIVING, PAIN, SWELLING, RADIOLUCENCY, A PERIPROSTHETIC FRACTURE, LOOSENING, SUBSIDENCE, AND POOR BONE QUALITY.

  Patient problems: Limited Mobility Of The Implanted Joint; Osteopenia/ Osteoporosis; Pain; Swelling

  MAUDE report 10524460 ↗

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