ATTUNE 1517-10-422Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX 22MM SIZE 4 · Class 3 · Implant
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295055877), received between Apr 22, 2025 and Apr 22, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF COMPONENTS OF LEFT KNEE. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY. PROCEDURE RELATED: DEFINITELY NOT. DATE OF EVENT: 29-JAN-2025. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440104. LOT NUMBER ID: J3198U. COMPONENT TYPE: FEMORAL COMPONENT. DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151316110. LOT NUMBER ID: J2332W. COMPONENT TYPE: FEMORAL STEM. DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904001. LOT NUMBER ID: J32A89. COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT. DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904002. LOT NUMBER ID: J4629Y. COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT. DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 150660004. LOT NUMBER ID: 9113354. COMPONENT TYPE: TIBIAL BASE COMPONENT. DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151214030. LOT NUMBER ID: J5202D. COMPONENT TYPE: TIBIAL STEM. DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151302000. LOT NUMBER ID: 8596354. COMPONENT TYPE: FEMORAL STEM O
Patient problems: Insufficient Information
MAUDE report 21882515 ↗
Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices
- ATTUNE 1506-10-005Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing442 reports
- ATTUNE 1506-10-004Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing442 reports
- ATTUNE 1518-20-038Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3 deaths393 reports
- LCS SIGMA 1294-33-130Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 recall310 reports
- ATTUNE 1518-20-035Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing342 reports
- P.F.C. SIGMA 96-0102Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 death319 reports
- ATTUNE 1518-20-041Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing308 reports
- ATTUNE 1506-10-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing284 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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