ATTUNE 1516-50-408Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295052319), received between Jan 26, 2018 and Jun 4, 2026 — classified as 31 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTHROFIBROSIS AND INSTABILITY HAD OCCURRED. THE PATELLA WAS STABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Arthrofibrosis; Joint Laxity

  MAUDE report 25395873 ↗
• InjuryMay 13, 2026Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT FELL EARLIER IN THE DAY AND DISASSOCIATED THE POLY FROM THE TIBIA AND FEMUR. THE 8MM POLY WAS EXTRACTED AND AN 18MM POLY WAS PUT IN TO INCREASE CONSTRAINT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 25163242 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 25116267 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24176884 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21936121 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT. A POLY SWAP WAS PERFORMED. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21737862 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21265550 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT FELL POST-OPERATIVELY. KNEE REVISION COMPLETED POST TRAUMA.

  Patient problems: Fall

  MAUDE report 21258215 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20882955 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19938127 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA HAD SUBSIDED PREVIOUS TO GROWING IN. IT WAS NOT LOOSE BUT RESULTED IN MID FLEXION INSTABILITY. SURGEON REVISED TIBIA AND POLY ONLY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18988565 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNI TO TOTAL KNEE REPLACEMENT. PATIENT HAS BEEN UNSTABLE. REVISED TO KNEE REVISION. THERE WAS NO SURGICAL DELAY. THERE WAS NO BROKEN INSTRUMENTS OR IMPLANTS. DOI: (B)(6) 2019 DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18825681 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S POLY SWAPPED FOR FAILURE DUE TO GLOBAL INSTABILITY. DOI: (B)(6), 2020. DOR: (B)(6), 2020. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 18258642 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15112603 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14654204 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN AND THE SURGEON PERFORMED A TIBIAL IMPLANT CHANGE. DOI: UNKNOWN; DOR: (B)(6) 2022; UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 13514731 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT"S KNEE FELT LOOSE AND UNSTABLE. THE 8MM POLY IMPLANT WAS REMOVED. ALL COMPONENTS WERE WELL FIXED. THE SURGEON TRIALED SEVERAL INSERTS AND A 14MM TRIAL SEEM TO GIVE THE PATIENT STABILITY. DOI: (B)(6) 2018 - DOR: (B)(6) 2021 (LEFT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 13043162 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO INSTABILITY. DOI: UNKNOWN, DOR: DEC. 6, 2021, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13023479 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. A DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11628617 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN. TWO DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11624792 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN, DYSFUNCTION, EXCISION OF HETEROTOPIC OSSIFICATION INVOLVING THE TIBIA AND FEMUR, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED BONE DEFECTS INVOLVING THE TIBIA AND FEMUR AS WELL AS SCAR EXCISION. THE PATELLAR COMPONENT WAS RETAINED. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11604284 ↗
• MalfunctionDec 29, 2020Expiration Date Error; Expiration Date Error

  PRODUCT THAT WAS IMPLANTED, HAD EXPIRED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> NO, ACTIVITY LEVEL --> INACTIVE/WALKING, (B)(6). DEVICE PROPERTY OF -->OTHER, DEVICE IN POSSESSION OF -->PATIENT. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088030 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC EFFUSION, REDUCED RANGE OF MOTION (+15 TO +80 DEGREES), PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. SHE HAD A PREVIOUS POLY REVISION BY THE SURGEON ON (B)(6) 2016. SHE HAD A FLEXION-EXTENSION GAP MISMATCH OF 4MM. THE ATTUNE TIBIAL TRAY CAME OUT WITH RELATIVE EASE ALTHOUGH SALES REP WAS SURE THAT THE SURGEON ALSO CHECKED THE FIXATION OF THE TIBIAL TRAY WHEN HE DID THE FIRST REVISION WITH POLY EXCHANGE BACK IN 2016. THE TRAY CAME OUT WITH EASE AND NO CEMENT ON THE BACK OF THE TRAY. DOI: (B)(6) 2015; (B)(6) 2016 (TIBIAL INSERT); DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10621467 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9815025 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS RUPTURED QUAD TENDON DUE TO FALL. SURGEON REPAIRED THE TENDON AND CHANGED THE INSERT TO A THICKER ONE. ALL OTHER COMPONENTS WERE WELL FIXED. DOI: (B)(6) 2019; DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9629331 ↗