ATTUNE 1518-10-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295056614), received between Oct 1, 2019 and Oct 22, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PREVIOUS REVISION FOR A LOOSE PATELLA COMPONENT. THE PATELLA HAD DEBONDED FROM THE BONE. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 23360434 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO SURGEON IN CLINIC WITH KNEE STIFFNESS AND WAS UNABLE TO GET KNEE INTO FULL EXTENSION. SURGEON PERFORMED FULL REVISION OF PRIMARY ATTUNE IMPLANTS TO ATTUNE REVISION WITH SLEEVES ON BOTH SIDES (TIBIA AND FEMUR).

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 22965779 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO MILD INSTABILITY, UNSPECIFIED PAIN AND LOOSENING OF THE PATELLA AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DURING THE SURGERY, IT WAS DISCOVERED THAT THE COMPONENT WAS LOOSE. IT WAS REPLACED WITH A 32 MM DOME PATELLA. DR. ALSO INCREASED THE THICKNESS OF THE POLY TO IMPROVE STABILITY. A SIZE 4 5 MM POLY WAS REMOVED AND A SIZE 48 MM POLY WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21954320 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REVISION FROM NEXGEN TO ATTUNE REVISION ON (B)(6) 2020. HAS PRESENTED WITH INSTABILITY AND X-RAY SHOWS THE TIBIA HAS SUBSIDED. CONCERNED WITH INTEGRITY OF THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS THE PATIENT HAS HAD KNEE REVISED ONCE AGAIN FOR A HINGE.

  Patient problems: Joint Laxity

  MAUDE report 20056141 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXPLANT OF IMPLANTS BECAUSE OF INFECTION. 2 STAGE REVISION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16637803 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUN 2019 WERE REVIEWED 07 OCT 2019 FOR REPORTABILITY PURPOSES. ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY DUE TO LEFT KNEE END-STAGE OSTEOARTHRITIS. ATTUNE KNEE IMPLANTS WERE PLACED ALONG WITH TWO SMARTSET CEMENTS. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE, AND CEMENT TO BONE INTERFACE. THE SURGEON NOTED THAT THERE WAS EARLY OSTEOLYSIS AND MINIMAL EFFUSION. THE PATELLA AND FEMORAL COMPONENT WERE REVISED EVEN THOUGH THEY WERE NOTED TO BE WELL FIXED. COMPETITOR COMPONENTS WERE PLACED DURING THE REVISION. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. DOI: (B)(6) 2015; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Edema; No Code Available; Osteolysis; Pain

  MAUDE report 9266405 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REV ORIGINAL SURGERY DONE (B)(6) 2016. PATIENT COMPLAINED OF PAIN, REMOVED PATELLA, POLY AND TRAY AND REPLACED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES.

  Patient problems: No Code Available; Pain

  MAUDE report 9140420 ↗