Persona® Partial Knee System 42-5380-007-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00880304812734), received between Jul 6, 2020 and Nov 24, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 20768414 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 19529256 ↗
• InjuryNov 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY TO ADDRESS TIBIAL LOOSENING AND PAIN THAT INCREASED WITH WEIGHT-BEARING APPROXIMATELY FOUR (4) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18074920 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED AN IN-OFFICE ASPIRATION TO TREAT A LARGE EFFUSION SIXTEEN (16) DAYS FOLLOWING A RIGHT PARTIAL KNEE ARTHROPLASTY. 90CC OF BLOODY FLUID WAS ASPIRATED WITH NO SIGNS OF INFECTION. THE PATIENT PROGRESSED WITH NO FURTHER COMPLICATIONS AND WAS SATISFIED WITH JOINT FUNCTION AND PAIN MANAGEMENT.

  Patient problems: Joint effusion; Pain

  MAUDE report 17010146 ↗
• InjuryMay 25, 2023Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT INITIAL UKA OPERATION WAS PERFORMED. POSTOPERATIVELY, FOLLOW-UP CONFIRMED THAT THE TIBIA PLATE WAS SINKING. AND A REVISION WAS PERFORMED ONE YEAR, ONE MONTH POST IMPLANTATION. AT THE REVISION, THE SURGEON FOUND A LOT OF WEAR ON THE REMOVED ARTICULAR SURFACE.

  Patient problems: Insufficient Information

  MAUDE report 17004257 ↗
• InjuryApr 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND BONE SCAN DISPLAYED IMPLANT LOOSENING APPROXIMATELY ONE YEAR POST IMPLANTATION. NO REVISION IS PLANNED AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16775849 ↗
• InjuryJun 30, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN AND BONE SCAN DISPLAYED IMPLANT LOOSENING APPROXIMATELY ONE YEAR POST IMPLANTATION. NO REVISION IS PLANNED AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 14874065 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT UNDERWENT A RIGHT KNEE TKA APPROXIMATELY TWO YEARS AGO. SUBSEQUENTLY THE PATIENT HAD A REVISION AFTER EXPERIENCING PAIN AND INFLAMMATION DUE TO A METAL ALLERGY.

  Patient problems: Inflammation; Pain; Reaction; Swelling

  MAUDE report 10233163 ↗

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