ATTUNE 1506-11-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 10603295416272), received between Jul 17, 2017 and Jun 26, 2026 — classified as 74 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (25 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE INFECTION. INSERTION FOR SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25642026 ↗
• InjuryOct 27, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS TIBIAL LOOSENING. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23389625 ↗
• InjuryMay 6, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO THE PRESSFIT TIBIA FAILED. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6), 2021, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21970791 ↗
• InjuryApr 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT'S BONE SCAN CAME BACK HOT AND SURGEON REVISED THE KNEE. THE TIBIA WAS LOOSE AND THE FEMUR HAD LITTLE BONE IN GROWTH. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21919194 ↗
• InjuryApr 22, 2025Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2023, PATIENT HAD UNDERWENT RIGHT KNEE WITH VELYS. ON (B)(6) 2025, PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO PAIN, SWELLING, AND INSTABILITY. PATIENT WAS FOUND TO HAVE ASEPTIC FEMORAL AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS UNDERLYING FIBROUS TISSUE AND THE CEMENT WAS REMOVED AFTER THE TIBIAL COMPONENT AND FEMORAL COMPONENTS WERE REMOVED. THE PATELLA WAS NOTED TO HAVE BEEN REMOVED AS WELL, BUT THERE WAS NO MENTION IMPLANT LOOSENING RELATED TO THE PATELLA. COMPETITOR IMPLANTS WERE PLACED AT REVISION. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fibrosis; Inadequate Osseointegration; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21882151 ↗
• InjuryJan 31, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Adhesion(s); Inadequate Osseointegration; Pain

  MAUDE report 21283966 ↗
• InjuryDec 4, 2024Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2023, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. ATTUNE KNEE IMPLANTS WERE IMPLANTED AND VELYS WAS USED. ON (B)(6) 2024, THE PATIENT HAD REVISION RIGHT TOTAL ARTHROPLASTY TO ADDRESS MECHANICAL ASEPTIC LOOSENING OF RIGHT TOTAL KNEE ARTHROPLASTY. IT WAS REPORTED THAT PATIENT HAD RECURRENT EPISODES OF ACHING PAIN, INSTABILITY, AND SWELLING. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE EASILY REMOVED AND THERE WAS NOTED FIBROUS TISSUE UNDERLYING THE COMPONENTS. COMPETITOR PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Inadequate Osseointegration; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20845102 ↗
• InjuryOct 25, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A PRESS FIT IMPLANT SO NO CEMENT WAS USED. NO PATIENT PROBLEMS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20533649 ↗
• InjuryOct 18, 2024Migration; Migration

  SURGEON STATED THE RIGHT ATTUNE RP CEMENTLESS TIBIAL TRAY SUBSIDED LATERALLY. TRAY WAS REMOVED WITHOUT INCIDENT AND THE POLY WAS INCREASED FROM A 5MM TO A 6MM. DOI: (B)(6) 2024, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20480266 ↗
• InjurySep 6, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20157206 ↗
• InjuryAug 14, 2024Migration; Migration

  IT WAS REPORTED THAT THE TIBIAL REVISION HAD BEEN PERFORMED DUE TO SUBSIDENCE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19981746 ↗
• InjuryApr 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: TIBIAL TRAY LOOSENING (UNKNOWN INTERFACE), INSTABILITY. AT REIVSION THER WAS POSTERIOR IMPINGMENT OF THE TIBIAL INSERT.

  Patient problems: Joint Laxity

  MAUDE report 19176579 ↗
• InjuryMar 26, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT HAD A TIBIAL FRACTURE AT TIME OF PRIMARY IMPLANT. WAS TOUCH WEIGHT BEARING TO ALLOW CEMENTLESS TIBIA TO INGROW AND THE FRACTURE TO HEAL. PATIENT PRESENTED FOR REVISION OF TIBIA FOR SUBSIDENCE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. WAS DEVICE EXPLANTED? TRUE. HARDWARE/EXPLANT REMOVAL DUE TO: TIBIAL SUBSIDENCE. DID PATIENT REQUIRE REVISION SURGERY? TRUE. IF YES, DATE OF REVISION SURGERY. REASON FOR REVISION SURGERY: TIBIAL SUBSIDENCE. DOI: (B)(6) 2024. DOE: (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18978611 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  ADDITIONAL INFORMATION WAS RECEIVED: 1. PT HAD A TIBIAL FRACTURE AT TIME OF PRIMARY KNEE SURGERY. SURGEON STATED FRACTURE WAS STABLE AT TIME OF PRIMARY SURGERY AND X-RAYS LOOKED GOOD. 2. FRACTURE WAS NOTICED BY ASSISTANCE POST IMPLANT INSERTION BUT WAS STABLE AND NOTHING TO BE DONE ABOUT IT OTHER THAN PT TO TOUCH WEIGHT BARE. 3. AS QUOTED FROM THE SURGEON TODAY ¿X-RAY POST SURGERY SHOWED THE FRACTURE WAS STABLE AND IMPLANTS LOOKED GOOD. POST SURGERY THE KNEE WAS PUT INTO HYPEREXTENSION BY THE PHYSIOTHERAPIST WHICH CAUSED SUBSIDENCE OF THE IMPLANT. 4. TIBIA FRACTURE OCCURRED AT TIME OF PRIMARY IMPLANT. SURGEON STATED THAT THE IMPLANT WAS STABLE POST SURGERY AND IN X-RAY. THE TIBIAL SUBSIDENCE OCCURRED POST A PHOTO PUTTING THE KNEE INTO HYPEREXTENSION.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 18977998 ↗
• InjuryMar 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 18977475 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY VIA TKA WITH THE IMPLANT IN QUESTION. THE IMPLANT IN QUESTION WAS REMOVED DUE TO INFECTION. ON (B)(6), 2024, THE SURGEON NOTED THAT THE IMPLANT IN QUESTION, WHICH HAD BEEN EXTRACTED IN THE PAST, WAS YELLOWISH. IT WAS ALSO NOTED THAT THE IMPLANT IN QUESTION MAY HAVE BEEN OXIDIZED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOE: (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 18835983 ↗
• InjuryJan 16, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE TIBIA IS LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18518663 ↗
• InjuryDec 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 18370949 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING REPEATED IMPACTION OF THE TIBIAL TRAY, A FRACTURE OCCURRED ON THE ANTERO-MEDIAL SIDE OF THE TIBIA. THE FRACTURE OCCURRED FROM THE MEDIAL ANTERIOR PEG HOLE AREA. THE SURGEON PERFORMED THE OSTEOSYNTHESIS WITH A CANCELLOUS SCREW. THE IMPLANT WAS REPLACED BY A CEMENT-FIXED TIBIAL TRAY OF THE SAME SIZE. THE SURGERY WAS EXTENDED BY 45 MINUTES. DOI: (B)(6) 2023; DOR: (B)(6) 2023; RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18265763 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DPO_14022. CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS OF THE LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2018. (LEFT KNEE). TREATMENT: I&D, SYNOVECTOMY, ARTHROLYSIS AND PHYSICAL THERAPY.

  Patient problems: Adhesion(s)

  MAUDE report 18004929 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE BONE TO IMPLANT INTERFACE. SURGEON INITIALLY THOUGHT PATIENT NEEDED A LARGER POLY BECAUSE OF A LITTLE FLEXION INSTABILITY, BUT THEN DISCOVERED FEMUR WAS SLIGHTLY LOOSE, REVISED ENTIRE KNEE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17855196 ↗
• InjuryAug 17, 2023Osseointegration Problem; Osseointegration Problem

  THIS PATIENT HAD HER KNEE REPLACED BY A SURGEON TWO YEARS AGO AND RECEIVED AN ATTUNE TOTAL KNEE. THE PATIENT RECENTLY FELL DOWN ON HER KNEE AND HER TIBIAL COMPONENT BECAME LOOSE. SURGEON REVISED THE KNEE, EXPLANTED THE POLY AND TIBIAL COMPONENTS AND IMPLANTED AN ATTUNE REVISION TIBIAL COMPONENT AND POLY. THE PATELLA AND FEMUR WERE WELL FIXED, LEFT IN SITU. NO SURGICAL DELAYS OR PRODUCT DEFECTS TO REPORT. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 17564208 ↗
• InjuryJun 19, 2023Migration; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATES THE DATE OF EVENT WAS 3 WEEKS AFTER THE INTERVENTION AND THE AFFECTED SIDE WAS THE LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 17151841 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17058378 ↗
• InjuryMar 13, 2023Osseointegration Problem; Osseointegration Problem

  THERE WAS NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16528792 ↗