ATTUNE 1514-04-150Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION CONCENTRIC CONE LARGE · Class 3 · Implant
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295520634), received between Jul 25, 2024 and Jul 10, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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
- Loss of or Failure to Bond3
- Adverse Event Without Identified Device or Use Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Insufficient Information3
- Joint Laxity1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INSTABILITY; IT WAS NOTED THERE WAS NO CEMENT.
Patient problems: Joint Laxity
MAUDE report 25779058 ↗InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
(B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION, ANESTHESIA REGIONAL (SPINAL, EPIDURAL). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 152020706, LOT NUMBER: M59R71, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 7 6MM. CATALOG NUMBER: 545050501, LOT NUMBER: 4473386, COMPONENT TYPE: CEMENT, DESCRIPTION: SMARTSET CEMENT WITH GENTAMICIN 40G. CATALOG NUMBER: 151404150, LOT NUMBER: 4112124, COMPONENT TYPE: CONE, DESCRIPTION: REVISION CONCENTRIC CONE LARGE. CATALOG NUMBER: 151404150, LOT NUMBER: 4112124, COMPONENT TYPE: CONE, DESCRIPTION: REVISION CONCENTRIC CONE LARGE.
Patient problems: Insufficient Information
MAUDE report 21984236 ↗InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: NO INFORMATION PROVIDED, DATE OF IMPLANT: NO INFORMATION PROVIDED, DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION, ANESTHESIA REGIONAL (SPINAL, EPIDURAL). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 152020706 LOT NUMBER: M59R71 COMPONENT TYPE: INSERT DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 7 6MM. CATALOG NUMBER: 545050501 LOT NUMBER: 4473386 COMPONENT TYPE: CEMENT DESCRIPTION: SMARTSET CEMENT WITH GENTAMICIN 40G. CATALOG NUMBER: 151404150 LOT NUMBER: 4112124 COMPONENT TYPE: CONE DESCRIPTION: REVISION CONCENTRIC CONE LARGE. CATALOG NUMBER: 151404150 LOT NUMBER: 4112124 COMPONENT TYPE: CONE DESCRIPTION: REVISION CONCENTRIC CONE LARGE.
Patient problems: Insufficient Information
MAUDE report 21984206 ↗InjuryMar 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION.
Patient problems: Insufficient Information
MAUDE report 21547777 ↗MalfunctionJul 25, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE ITEMS WERE DAMAGED IN TRANSIT. THE OUTER BOXES WERE SMASHED IN TRANSIT AND CAUSED THE IMPLANTS TO BE DAMAGED AS WELL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19825678 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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