Persona® Partial Knee System 42-5380-004-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304812666), received between Nov 20, 2019 and Jun 19, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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.

• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A KNEE ARTHROPLASTY. APPROXIMATELY 2.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO A PERI-PROSTHETIC FRACTURE AND PAIN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 22292755 ↗
• InjuryApr 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HEMIARTHROPLASTY. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, DIFFICULTY AMBULATING, AND LOOSENING. DURING THE REVISION, PERIPROSTHETIC FRACTURE TO THE TIBIA WAS NOTED. ALL COMPONENTS WERE REPLACED WITH CONVERSION TO TOTAL KNEE REPLACEMENT WITHOUT COMPLICATIONS.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pain

  MAUDE report 16776368 ↗
• InjuryDec 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HEMIARTHROPLASTY. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, DIFFICULTY AMBULATING, AND LOOSENING. DURING THE REVISION, PERIPROSTHETIC FRACTURE TO THE TIBIA WAS NOTED. ALL COMPONENTS WERE REPLACED WITH CONVERSION TO TOTAL KNEE REPLACEMENT WITHOUT COMPLICATIONS.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pain

  MAUDE report 15931702 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE ARTICULAR SURFACE TO ADDRESS INFECTION EIGHTEEN (18) DAYS POSTOPERATIVELY. THE INFECTION DID NOT RESOLVE AND AN ADDITIONAL ARTICULAR SURFACE REVISION WAS PERFORMED SIXTEEN (16) FOLLOWING THE FIRST REVISION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11588131 ↗
• InjuryFeb 5, 2021Adverse 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: Pain; Swelling

  MAUDE report 11285679 ↗
• InjurySep 11, 2020Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling

  MAUDE report 10522447 ↗
• InjurySep 8, 2020Adverse 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: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 10501462 ↗
• InjuryApr 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY. CEMENT WAS USED FOR THE TIBIAL AND FEMORAL COMPONENTS. AT THE 3-MONTH POST-OP VISIT, THERE WERE NO REPORTED PROBLEMS. AT THE 1-YEAR POST-OP VISIT, THE PATIENT REPORTED MODERATE PAIN. AT THE 2-YEAR POST-OP VISIT, LITTLE MEDIAL/LATERAL INSTABILITY WAS NOTED ALONG WITH RADIOGRAPHIC FINDINGS OF A TIBIAL FRACTURE. SUBSEQUENTLY; THE PATIENT UNDERWENT REVISION APPROXIMATELY 2 YEARS POST IMPLANTATION TO REPLACE THE TIBIAL COMPONENT DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Pain

  MAUDE report 9949048 ↗
• InjuryNov 20, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: No Code Available

  MAUDE report 9350326 ↗

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