Persona® Partial Knee System 42-5380-006-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304812703), received between Jan 23, 2020 and Sep 30, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity; Periprosthetic fracture

  MAUDE report 50946495 ↗
• InjurySep 30, 2026Implant subsidence

  It was reported that a patient had an initial left partial knee arthroplasty performed. Approximately 6-8 weeks postop, the patient was participating in physical therapy and felt a sudden pain with inability to walk. X-rays revealed a periprosthetic tibial fracture with implant subsidence. As a result, the patient underwent an open reduction internal fixation. The initial partial knee implants remained intact. No further details regarding the event are known at this time.

  Patient problems: Ambulation or Postural Difficulties; Pain; Periprosthetic fracture

  MAUDE report 50946339 ↗
• InjuryMar 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL BILATERAL PPK SURGERY. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PROXIMAL TIBIAL PAIN ON THE LEFT AND WAS REVISED DUE TO PAIN AND TIBIAL LOOSENING APPROXIMATELY 1 YEAR POST-OP. THE SURGEON NOTED THERE WAS SLIGHT TIBIAL MICROMOTION. ALL COMPONENTS WERE REVISED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24639620 ↗
• 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 22372712 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT PARTIAL KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21928010 ↗
• InjuryAug 9, 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 19948466 ↗
• 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: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 11586045 ↗
• InjuryFeb 5, 2020Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

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

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 9672279 ↗
• InjuryJan 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE WAS REPORTED UNDER THE INCORRECT MANUFACTURING SITE MFR. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. PLEASE SEE 0001825034-2020-00490.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 9622805 ↗

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