ATTUNE 1523-01-001Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT UNIVERSAL 5MM CEMENTED SIZE 1/2 · Class 2 · Implant
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295057499), received between Dec 26, 2024 and Dec 26, 2024 — classified as 2 injuries.
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 Problem2
Patient problems
- Bone Fracture(s)2
- Fall2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT FELL AND FRACTURED TIBIA. THE TIBIA IMPLANTS WERE EXPLANTED, AND NEW ONES WERE INSERTED WITH A LONGER STEM TO BYPASS THE FRACTURE. THERE WAS NO SURGICAL DELAY OR CONSEQUENCES TO THE PATIENT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Bone Fracture(s); Fall
MAUDE report 21018929 ↗InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT FELL AND FRACTURED TIBIA. THE TIBIA IMPLANTS WERE EXPLANTED, AND NEW ONES WERE INSERTED WITH A LONGER STEM TO BYPASS THE FRACTURE. THERE WAS NO SURGICAL DELAY OR CONSEQUENCES TO THE PATIENT. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Bone Fracture(s); Fall
MAUDE report 21018824 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 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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