Persona® Partial Knee System 42-5380-004-02Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Persona Partial Knee System (60)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304812673), received between Apr 10, 2020 and May 22, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Pain4
- Aseptic loosening1
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2025Loosening 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: Aseptic loosening; Pain
MAUDE report 22073966 ↗InjuryMay 22, 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: Pain
MAUDE report 19376753 ↗InjuryMar 8, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND TIBIAL FRACTURE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 13697027 ↗InjurySep 1, 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: Bone Fracture(s)
MAUDE report 10478735 ↗InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE IS RELATED TO ONGOING ISSUES PREVIOUSLY REPORTED ON 0001825034-2019-00604.
Patient problems: Pain
MAUDE report 9947764 ↗
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 · TerminatedPersona 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 · TerminatedPersona Partial Knee System, Size 8, Finishing Guide
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 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.
How reports and recalls are matched · Editorial policy · Report an error on this page