ATTUNE 1506-00-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 580 adverse event reports that list this exact device (DI 10603295042389), received between Jun 21, 2017 and Aug 7, 2026 — classified as 578 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (455 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 580 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Loss of or Failure to Bond

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. (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 loose debonded tibia and loose patella. The non-articular surface of the fixed-bearing polyethylene tibial insert shows minor yellowing. The articular surface of the patella shows minor yellowing. The non-articular surface of the cemented tibial tray shows no cement remaining, and relative motion between bone and metal.

  Patient problems: Insufficient Information

  MAUDE report 50176525 ↗
• InjuryJul 29, 2026Loss of or Failure to Bond

  It was reported that the patient experienced aseptic tibial loosening. Tibia loosened at the cement/implant interface. All components were revised. Femur was not loose. No patient injury or delay.DOI: Unknown DOR: (b)(6), 2026Affected side: Right Knee.

  Patient problems: Insufficient Information

  MAUDE report 50073314 ↗
• InjuryJul 29, 2026Loss of or Failure to Bond

  It was reported that patient had aseptic tibial loosening and patellar lysis. All components were revised. Tibia was loose at the tray/cement interface. Femur was not loose. It was stated that tibia and patella were loose. Loosening interface was marked as cement to implant.Affected side-Right knee.

  Patient problems: Insufficient Information

  MAUDE report 50071994 ↗
• InjuryJul 27, 2026Loss of or Failure to Bond

  It was reported that patient had an Attune Tibial base plate with cement debonding. Patient had a previous Bilateral Knee replacement done in 2017 -2018 (est). Patient developed aseptic loosening in the past few months and necessitated the revision of the Tibia tray to a Revision tibia tray. Upon extraction, the tray does not seem to have any bone cement adhering to the tray. Procedure was completed successfully with no delay. The implant was discarded.

  Patient problems: Insufficient Information

  MAUDE report 50035553 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 25888631 ↗
• InjuryMar 16, 2026Loss of or Failure to Bond; Migration

  ON (B)(6) 2015, PLAINTIFF UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. AFTER THE ATTUNE SYSTEM WAS IMPLANTED, PLAINTIFF BEGAN EXPERIENCING SEVERE AND PERSISTENT PAIN, DISCOMFORT, INSTABILITY AND DIFFICULTY AMBULATING CAUSED BY ASEPTIC LOOSENING OF THE DEFECTIVE ATTUNE TIBIAL BASEPLATE. ON (B)(6) 2022, PLAINTIFF UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE COMPONENTS OF THE ATTUNE SYSTEM IMPLANTED IN HER LEFT KNEE. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inflammation; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 24605221 ↗
• InjuryFeb 17, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LOOSE FEMORAL AND TIBIAL COMPONENT. FEMUR AND TIBIAL TRAY WERE LOOSE AT CEMENT TO IMPLANT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24364902 ↗
• InjuryFeb 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT THE REVISION KNEE SURGERY DUE TO PAIN, WHERE THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE AND WAS REVISED WITH A REVISION TIBIA, TIBIAL STEM, AND SLEEVE FOR STABILITY. THERE WAS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24273122 ↗
• InjuryJan 30, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSE TIBIA AT THE IMPLANT CEMENT INTERFACE. DOI- (B)(6) 2014. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24225311 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR KNEE CONTRACTURE S/P TKA, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: POSSIBLY RELATED, PROCEDURE RELATED: POSSIBLY RELATED, DATE OF EVENT: 02 JUL 2014, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, MANIPULATION UNDER ANESTHESIA. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150600004, LOT NUMBER ID: 7800700, COMPONENT: TIBIAL, DESCRIPTION: ATTUNE KNEE SYSTEM TIBIAL BASE FIXED BEARING SIZE 4 CEMENTED.

  Patient problems: Septic loosening

  MAUDE report 24079989 ↗
• InjuryJan 9, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION KNEE SURGERY FOR A LOOSE TIBIAL TRAY. LOOSE IMPLANT WAS REMOVED AND REPLACED WITH A REVISION ATTUNE RP TRAY, TIBIAL SLEEVE AND TIBIAL STEM. NO FURTHER DETAILS OR INFORMATION IS AVAILABLE OTHER THAN THE TIBIAL IMPLANT WAS A FIRST GENERATION ATTUNE FIXED BEARING TIBIAL. TIBIAL TRAY WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24023308 ↗
• InjuryJul 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. IMPLANTS WERE REMOVED, THERE WAS LOOSENING OF THE TIBIAL TRAY AT CEMENT TO THE IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22530090 ↗
• InjuryMay 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID:(B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ORTHOPAEDIC AFTERCARE WITH HISTORY OF TOTAL KNEE REPLACEMENT (RIGHT TKR TIBIAL ASEPTICLOOSENING) DEVICE AND PROCEDURE (RELATEDNESS) DEVICE: DEFINITELY PROCEDURE: NOT RELATED DATE OF EVENT: 12 DEC 2024 DATE OF IMPLANT: (B)(4) 2014 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: MEDICAL INTERVENTION/ MODIFICATION, PHYSICAL THERAPY, IRRIGATION & DEBRIDEMENT, RIGHT TOTAL KNEE REPLACEMENT TIBIAL ASEPTICLOOSENING. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150600004 LOT NUMBER: 7869589 COMPONENT TYPE: TIBIAL DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22041073 ↗
• InjuryJan 21, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT RECEIVED A SECOND RIGHT KNEE REVISION TO TREAT PAIN, SWELLING, AND INSTABILITY SECONDARY TO LOOSENING AND MIGRATION OF THE TIBIAL TRAY. THE PATIENT HAD A PREVIOUS REVISION OF THE TIBIAL INSERT TO TREAT INSTABILITY AND POLY-WEAR ON (B)(6) 2019. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED THE TIBIAL TRAY WAS MIGRATED AND GROSSLY LOOSE AT THE COMPETITOR CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED UNKNOWN TIBIAL INSERT. THE PATELLA WAS WELL-FIXED WITH MILD WEAR BUT RETAINED. THE PATIENT RECEIVED A DEPUY ATTUNE STEMMED REVISION CONSTRUCT SECURED WITH COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THIS PC WAS LINKED TO (B)(4) LEFT KNEE FIRST REVISION, (B)(4) LEFT KNEE SECOND REVISION. (B)(4) RIGHT KNEE FIRST REVISION. DOI: ON (B)(6) 2014, DOR: ON (B)(6) 2019 (PRIMARY TIBIAL INSERT CAPTURED ON (B)(4), DOR: ON (B)(6) 2023 (UNK INSERT AND TIBIAL TRAY), RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21201336 ↗
• InjuryJan 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION FOR RIGHT KNEE ANTERIOR PAIN WITH TIBIAL ASEPTIC LOOSENING AT THE IMPLANT/CEMENT INTERFACE. CEMENT IS A COMPETITOR PRODUCT.

  Patient problems: Pain

  MAUDE report 21104902 ↗
• InjuryDec 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS A LOOSE TIBIAL COMPONENT, FOR CEMENT TO IMPLANT INTERFACE. UNKNOWN PATIENT CONSEQUENCE AND SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2015 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20887073 ↗
• InjuryOct 28, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT BROUGHT TO OR FOR REVISION OF TIBIAL COMPONENT DUE TO ASEPTIC LOOSENING. TIBIAL COMPONENT CONFIRMED LOOSE WITHOUT ANY EVIDENCE OF CEMENT BONDING. THERE WAS A LOOSENING REPORTED IN TIBIAL BASE AT CEMENT TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20544302 ↗
• InjuryOct 25, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  REVISION OF AN ATTUNE PS FB CONSTRUCT WHICH WAS IMPLANTED IN 2017. REASON FOR REVISION WAS DUE TO TIBIAL LOOSENING. INSERT, FEMUR, AND TIBIA WERE EXPLANTED AS PER IMPACTED PRODUCTS. DOME PATELLA WAS RETAINED. PATIENT HAD A HIGH BMI. THE SURGEON CUT TIBIA IN SLIGHT VALGUS. PATIENT GOT BETTER BUT THEN PRESENTED TO CLINIC THIS YEAR FOR INCREASED PAIN. THE TIBIA WAS LOOSE AND HAD COLLAPSED INTO VARUS. THE TIBIA WAS REMOVED BY LIFTING WITH AN OSTEOTOME AND THERE WAS NOT ONE SPEC OF CEMENT ON THE TIBIA. THE SURGEON MADE AN ALLEGATION ABOUT THE FAILURE OF THE IMPLANT DUE TO IMPLANT-CEMENT INTERFACE. THE BONE-CEMENT INTERFACE WAS IN TACT. THE FEMUR WAS WELL FIXED AND HAD EXCELLENT BONE-CEMENT AND IMPLANT-CEMENT INTERFACE.

  Patient problems: Pain

  MAUDE report 20532479 ↗
• InjuryOct 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL RIGHT KNEE REVISION FOR TIBIAL ASEPTIC LOOSENING. THE IMPLANT/CEMENT INTERFACE WITH CEMENT NOT FROM DEPUY. HARDWARE WAS REMOVED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 20427797 ↗
• InjuryAug 28, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED FOR ASEPTIC LOOSENING OF FEMUR AT CEMENT TO IMPLANT INTERFACE. THE TIBIA WAS ALSO REPORTED AS A LOOSENING COMPONENT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20086199 ↗
• InjuryJul 12, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  DURING A TOTAL KNEE REVISION A FIRST GENERATION ATTUNE TIBIAL PLATE WAS FOUND TO BE LOOSE AND HAVING SUBSIDED. THE INITIAL SURGERY WAS DONE IN 2015. SURGERY CONSISTED OF A TIBIAL ONLY REVISION. HOSPITAL RETAINED THE IMPLANT AND IT IS NOT AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 19731947 ↗
• InjuryJul 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD A LEFT TOTAL KNEE DONE AT UNKNOWN TIME, LOCATION, AND SURGEON. THIS WAS AN ATTUNE FIXED BEARING PS TOTAL KNEE. THERE WAS LOOSENING OF THE TIBIA COMPONENT AT CEMENT TO IMPLANT INTERFACE AND CAME IN FOR REVISION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN, DOR- (B)(6) 2024, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19667552 ↗
• InjuryJul 1, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2019. DOR:(B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19645311 ↗
• InjuryJun 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A TKA WITH THE TIBIAL TRAY IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT HAD NOT BEEN SEEN AGAIN FOR POSTOPERATIVE FOLLOW-UP. THEN, THE PATIENT FELT PAIN AND VISITED TO THE HOSPITAL. IMPLANT LOOSENING WAS CONFIRMED. THE IMPLANT WAS REMOVED, AND IT WAS REPLACED WITH PCCK. THE CAUSE OF THE LOOSENING IS DEBONDING DUE TO THE IMPLANT DESIGN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19479003 ↗
• InjuryMay 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2017 THE PATIENT HAD BILATERAL KNEE ARTHROPLASTIES TO ADDRESS SEVERE PRIMARY OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THESE PROCEDURE, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 (LEFT KNEE STICKER SHEET PAGE 7 OF 16)(RIGHT KNEE STICKER SHEET PAGE 16 OF 16). ON (B)(6) 2023, THE PATIENT HAD A LEFT KNEE REVISION TO ADDRESS THE MECHANICAL FAILURE OF THE PROSTHETIC LEFT KNEE JOINT. DURING THE PROCEDURE, THE SURGEON NOTED THERE WAS A LARGE AMOUNT OF SCAR TISSUE, THERE WAS EXTENSIVE THICKNESS OF THE PATELLA AND IT WAS REMOVED. THERE WAS EVIDENCE OF LOOSENING OF THE TIBIAL TRAY COMPONENT WITH SEPARATION OF THE TIBIAL TRAY FROM THE CEMENT MANTLE. ALL COMPONENTS WERE REMOVED AND COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2017. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 19277485 ↗