ATTUNE 1506-00-005Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL BASE FIXED BEARING SIZE 5 CEMENTED · Class 2 · Implant
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune tibial base is a knee implant that is held in place with cement. Most of the 589 reports describe loosening where the implant meets the cement, and many mention pain and revision surgery. The reports include 587 injuries and no deaths, and reports fell from 17 in the previous 12 months to 8 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 589
- Deaths reported
- 0
- Injuries reported
- 587
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 589 adverse event reports that list this exact device (DI 10603295042396), received between Jun 22, 2017 and Aug 7, 2026 — classified as 587 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (440 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond440
- Adverse Event Without Identified Device or Use Problem73
- Migration59
- Loose or Intermittent Connection35
- Loosening of Implant Not Related to Bone-Ingrowth28
- Insufficient Device Problem Information17
- Migration or Expulsion of Device13
- Unintended Movement11
Patient problems
- No Code Available334
- Pain282
- Insufficient Information67
- Not Applicable65
- Adhesion(s)46
- Edema34
- Synovitis27
- No Consequences Or Impact To Patient24
Recent adverse event reports
The 25 most recent of 589 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to instability and pain. The non-articular surface of the fixed-bearing polyethylene tibial insert shows minor yellowing.
Patient problems: Joint Laxity; Pain
MAUDE report 50173431 ↗InjuryJul 21, 2026Migration
IT WAS REPORTED THAT THERE WAS A TIBIAL SUBSIDENCE REQUIRING REVISION SURGERY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.
Patient problems: Insufficient Information
MAUDE report 25898394 ↗InjuryJul 20, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO KNEE TIBIAL TRAY LOOSENING AT CEMENT TO IMPLANT INTERFACE. IMPLANTS WERE EXPLANTED DUE TO POTENTIAL LOOSENING. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 25873682 ↗InjuryJul 1, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL TRAY LOOSENING AT CEMENT TO IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED. THE FEMUR WASN'T LOOSE AND CAME OFF AT THE CEMENT/BONE INTERFACE. THE TIBIA WAS LOOSE AND CAME OFF AT THE CEMENT/IMPLANT INTERFACE. NO DELAYS OR PATIENT INJURY. NO MORE INFO KNOWN. AFFECTED SIDE: RIGHT.
Patient problems: Insufficient Information
MAUDE report 25680883 ↗InjuryMar 2, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF START UP PAIN. X-RAYS SHOWED LOOSE TIBIA AND FEMUR. IT WAS STATED THAT FEMUR & TIBIA WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT/IMPLANT. AFFECTED SIDE: LEFT KNEE.
Patient problems: Pain
MAUDE report 24481966 ↗InjuryFeb 17, 2026Loss of or Failure to Bond
PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF AN ATTUNE TIBIAL BASEPLATE. ORIGINAL SURGERY WAS DONE IN 2015. DOI: UNKNOWN DOR: (B)(6) 2026 AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24369931 ↗InjuryDec 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION FOR PAIN AND TIBIAL ASEPTIC LOOSENING AT THE IMPLANT/CEMENT INTERFACE. CEMENT NOT FROM DEPUY.
Patient problems: Pain
MAUDE report 23852122 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO PAIN. TIBIAL INSERT SHOWED MODERATE YELLOWING.
Patient problems: Pain
MAUDE report 23465914 ↗InjurySep 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL AND FEMORAL COMPONENTS AT CEMENT TO IMPLANT INTERFACE. PATIENT SHOWED SIGNS OF A LOOSE FEMORAL COMPONENT. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2018, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 23097542 ↗InjurySep 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL FRACTURE CAUSING LOOSING. AFFECTED SIDE: LEFT KNEE.
Patient problems: Bone Fracture(s)
MAUDE report 23025013 ↗InjuryJul 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22456427 ↗InjuryJul 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2025, THE PATIENT HAD A LEFT TOTAL REVISION TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT WITH DEBONDING OF THE CEMENT, MEDICAL POLYETHYLENE WEAR WITH SOME OSTEOLYSIS, MILD MID FLEXION INSTABILITY WITH EXTERNAL ROTATION OF THE FEMORAL COMPONENT. THE INDICATIONS FOR SURGERY INCLUDE PAIN. DOI: (B)(6) 2016, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.
Patient problems: Joint Laxity; Pain
MAUDE report 22440773 ↗InjuryJun 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE TIBIA WAS LOOSE. IT CAME OUT COMPLETELY DE BONDED FROM THE CEMENT. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 22289371 ↗InjuryMay 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
TIBIA ONLY REVISION. TIBIA WAS LOOSE AT CEMENT IMPLANT INTERFACE. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 22097116 ↗InjuryMay 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO LOOSE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. THE PATELLA AND FEMORAL COMPONENT WERE BOTH NOTED TO BE WELL FIXED AND RETAINED. AT REVISION A DEPUY TIBIAL TRAY AND STEM WERE PLACED. RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 22089502 ↗InjuryMay 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AND FEMUR AT CEMENT TO IMPLANT INTERFACE. THERE WAS NO PATIENT HARM OR CONSEQUENCES RELATED TO THE EVENT. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 22055717 ↗InjuryMay 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSENING: UNKNOWN COMPONENT(S). THE FEMORAL COMPONENT SHOWED ABUNDANT CEMENT REMAINING WITH EXCELLENT INTERDIGITATION WITH BONE. THE TIBIAL TRAY SHOWED NO CEMENT REMAINING. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21976392 ↗InjuryMar 5, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT ASEPTIC TIBIAL LOOSENING OCCURRED AT THE CEMENT/IMPLANT INTERFACE. REVISION WAS PERFORMED. AFFECTED SIDE: LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 21529353 ↗InjuryJan 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSE ATTUNE TIBIAL TRAY. THE LOOSENING INTERFACE WAS CEMENT TO IMPLANT. THERE WAS NO CEMENT BONDED TO THE TRAY. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 21207363 ↗InjuryJan 15, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT NEEDED A TOTAL KNEE REVISION DUE TO LOOSE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 21160124 ↗InjuryDec 2, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration
ADDITIONAL EVENT INFORMATION STATES THAT THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20820977 ↗InjuryNov 27, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF SUBSIDED TIBIA AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 20798659 ↗InjuryNov 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
PATIENT LEFT KNEE WAS REVISED ON (B)(6) 2024 DUE TO ASEPTIC TIBIAL LOOSENING AT THE TRAY/CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. TIBIA CAME OUT CLEAN. THE FEMUR WASN'T LOOSE BUT ALL WAS REVISED TO CRS IMPLANTS. SURGICAL DELAY WAS UNKNOWN. DATE OF IMPLANT ON (B)(6) 2013.
Patient problems: Insufficient Information
MAUDE report 20653140 ↗InjuryNov 7, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE CEMENT MANTLE FAILED ON BOTH TIBIA AND FEMUR. BOTH COMPONENTS WERE LOOSE. PATIENT WAS NOT INJURED. THERE WAS LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 20634023 ↗InjuryNov 7, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
DOI: (B)(6) 2016: 54-YEAR-OLD FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X1 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2024: FEMALE PATIENT RECEIVED A TOTAL RIGHT KNEE REVISION TO TREAT LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON EXPRESSED A LARGE EFFUSION AND IDENTIFIED AND DEBRIDED METALLOSIS SECONDARY TO LOOSENING OF THE TIBIAL TRAY. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT COMPETITOR CEMENT TO IMPLANT INTERFACE AND REVISED. SURGEONS PERFORMED A COMPLETE SYNOVECTOMY TO ENSURE COMPLETE REMOVAL OF ALL METALLOSIS. THE FEMORAL COMPONENT AND PATELLA WERE WELL-FIXED AND RETAINED. THE REVISED TIBIAL INSERT SHOWED EVIDENCE OF WEAR AND PITTING. THE PATIENT RECEIVED A DEPUY ATTUNE REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Foreign Body Reaction; Swelling/ Edema
MAUDE report 20630607 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- 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
- P.F.C. SIGMA 96-0781Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER236 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.
How reports and recalls are matched · Editorial policy · Report an error on this page