PERSONA® 42-5271-008-10Recalls & reported problems
Zimmer, Inc. · Class 2
All models of PERSONA (364)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024245167), received between Dec 16, 2020 and Jun 5, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2024Fracture; Fracture
IT WAS REPORTED THAT AFTER THE CASE WHEN CLEANING, THE CENTRAL STERILE TECHNICIAN BROKE THE POLY TRIALS WHEN DISASSEMBLING THEM. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19468538 ↗MalfunctionFeb 27, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16443627 ↗MalfunctionOct 24, 2022Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15658166 ↗MalfunctionOct 14, 2022Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15605803 ↗MalfunctionDec 16, 2020Fracture; Fracture
IT WAS REPORTED PROVISIONAL FRACTURED DURING STERILE PROCESSING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 11018652 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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