ATTUNE 1516-30-607Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295047889), received between Sep 12, 2019 and Sep 17, 2026 — classified as 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (5 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 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Impaired Healing

  MAUDE report 50811814 ↗
• InjuryNov 14, 2025Unintended Movement; Unintended Movement

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY WITH DISLOCATED AND SPUN-OUT ROTATING PLATFORM LINER, IRREDUCIBLE. SIGNIFICANT INTRAOPERATIVE INBALANCE IDENTIFIED WITH POSTEROLATERAL INSTABILITY REQUIRING COMPLETE REVISION. PATELLAR COMPONENT RETAINED. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: PROBABLE/ PROCEDURE RELATED: PROBABLE. DATE OF EVENT: 25 SEP 2025. DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NONE/OBSERVATION: YES, COMPONENTS REMOVED: FEMORAL: YES, TIBIA: YES, AND INSERT: YES.

  Patient problems: Joint Laxity

  MAUDE report 23555114 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION AND NEEDED IMPLANTS REMOVED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23036969 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY THAT BECAME INFECTED. THIS, IN TURN, AFFECTED THE TOTAL JOINT IN THE LEFT KNEE. AND I&D OF THE TOTAL JOINT WAS DONE, AND A NEW POLY WAS IMPLANTED. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22561195 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED INSERT EXCHANGE IN AN ATTUNE PRIMARY (CR RP CONSTRUCT) DUE TO INFECTION - PUS WAS SEEPING OUT OF THE SCAR BEFORE THE SURGERY EVEN STARTED. THE PRIMARY KNEE REPLACEMENT WAS COMPLETED 52 DAYS PRIOR. NO DAMAGE TO THE REMOVED INSERT WAS OBSERVED.

  Patient problems: Unspecified Infection

  MAUDE report 21884710 ↗
• InjuryJul 2, 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 PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19657356 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19574360 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: DEC 18, 2023. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 18424609 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PRIMARY SURGERY WAS PERFORMED VIA TKA FOR RIGHT OA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY ON AN UNKNOWN DATE, THE PATIENT CAME TO THE HOSPITAL WITH FEVER. THE RIGHT KNEE WAS RED AND HOT. THE SURGEON THOUGHT IT WAS A LATE INFECTION. ON (B)(6) 2023, THE REVISION SURGERY WAS PERFORMED TO CLEAN THE AFFECTED AREA AND TO REPLACE THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DOI: (B)(6) 2022. DOR:(B)(6) 2023. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17237975 ↗
• InjuryApr 11, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT HAD A BEARING SPIN . THE DECISION TO REMOVE ALL IMPLANTS AND REVISE TO ATTUNE REVISION AS THE KNEE HAD BECOME UNSTABLE IN FLEXION. BETTER RESULT AT END OF CASE.

  Patient problems: Joint Laxity

  MAUDE report 16713284 ↗
• InjuryApr 11, 2023Unintended Movement; Unintended Movement

  PATIENT HAD AN ATTUNE TOTAL KNEE REPLACEMENT 24HRS AGO AND 1 DAY POST OP THE POLY DISLOCATED. PATIENT WAS REDUCED CLOSED AND A PLASTER PUT ON IN EXTENSION. DR BELIEVES THIS IS INSTRUMENT RELATED.

  Patient problems: Insufficient Information

  MAUDE report 16712394 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS TAKEN OUT DURING WASHOUT. DOI- UNKNOWN; DOR- (B)(6) 2022; AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15337620 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGEON CHANGED POLY FROM 7 MM TO 10 MM SIZE 6 CR. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15211726 ↗
• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI - (B)(6) 2022, DOR - (B)(6) 2022, AFFECTED SIDE - RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14406971 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 14171764 ↗
• MalfunctionApr 21, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  THE FOAM PLATE WAS INCORRECTLY PLACED IN THE PACKAGING AND PARTIALLY WELDED TO THE PACKAGING. IT WAS QUESTIONABLE IF THE INLAY WAS COMPLETELY STERILE. INSERT WAS NOT USED DUE TO HAVING A REPLACEMENT AVAILABLE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166290 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY OF THE KNEE. IMPLANTS WERE REMOVED AND REPLACED. DOI : UNKNOWN. DOR : (B)(6) 2022. RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 13334335 ↗
• InjurySep 22, 2021Unintended Movement; Unintended Movement

  REVISION FOR BEARING DISLOCATION, (SPIN OUT). FEMORAL COMPONENT CHANGED TO PS ATTUNE AND 1MM THICKER PS BEARING. BEARING WAS VERY DIFFICULT TO DISLOCATE DURING REVISION SURGERY ONCE REDUCED. PRIMARY IMPLANTED BY SURGEON (B)(6) 2021 (B)(6) HOSPITAL. DOI: (B)(6) 2021. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Joint Laxity

  MAUDE report 12513659 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE WITH LIMITED ROM. SURGEON DOWNSIZED POLY AND RESECTED PATELLA. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12378646 ↗
• InjuryOct 22, 2020Unintended Movement; Unintended Movement

  PATIENT PRESENTED ON (B)(6) 2020 WITH BEARING SPINOUT, AND HAD A BEARING EXCHANGE TO 10MM INSERT. DOI: (B)(6) 2020. DOR: (B)(6) 2020 (POLY EXCHANGED). DOR: (B)(6) 2020 (ALL COMPONENT REMOVED).

  Patient problems: No Code Available

  MAUDE report 10718282 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: MEDICAL RECORDS RECEIVED ON AD (B)(6) 2020 WERE REVIEWED ON AD (B)(6) 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT PREMATURE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN AND INSTABILITY SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED SYNOVITIS AND SWELLING. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REMOVED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE SURGEON NOTES THERE WAS AORI TYPE 2A BONE LOSS OF THE FEMUR AND TIBIA REQUIRING RECONSTRUCTION. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT WAS REVISED WITH A COMPETITOR CONSTRUCT UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10535784 ↗
• InjurySep 3, 2020Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT KNEE ATTUNE REVISION TO TREAT PAIN, SCAR TISSUE, WALKING DIFFICULTY, FLEXION CONTRACTURE, AND JOINT INSTABILITY. UPON ENTERING THE JOINT, THE SURGEON DETERMINED THAT THE FLEXION CONTRACTURE WAS DUE TO ABUNDANT SCAR TISSUE ADHERING TO THE QUADRICEPS TENDON, WHICH REQUIRED A QUADRICEPS PLASTY TO REPAIR. ABUNDANT SCAR TISSUE AND SYNOVITIS WAS DEBRIDED FROM THE PERIARTICULAR SPACE. THE SURGEON IDENTIFIED SIGNIFICANT WEAR DEBRIS THROUGHOUT THE JOINT. THE TIBIAL TRAY WAS GROSSLY LOOSE AT THE CEMENT TO IMPLANT INTERFACE AND REMOVED. THERE WAS A SIGNIFICANT TIBIAL BONE EROSION. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. ONCE REMOVED, THE SURGEON IDENTIFIED DISTAL FEMORAL STRESS SHIELDING, OSTEOPENIA, AND CONDYLE BONE EROSION. THE BONE DEFECTS IN THE TIBIA AND FEMUR REQUIRED RECONSTRUCTION WITH A STEM AND CONE. THE PATELLA WAS WELL-FIXED, WITHOUT WEAR, AND RETAINED. THE TIBIAL INSERT WAS REVISED. THE PATIENT WAS REVISED WITH A COMPETITOR CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON NOTED THAT THE PATIENT¿S OBESITY WAS A CONTRIBUTING FACTOR TO THE FAILURE OF THE ATTUNE KNEE. DOI: (B)(6) 2015 DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; No Code Available; Pain; Pocket Erosion; Synovitis

  MAUDE report 10489863 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSE FLEXION. IT WAS ASSUMED THAT THE TRAY WAS LOOSE BUT IT WAS VERY WELL FIXED AND THERE WAS LESS THAN 50% OF THE TRAY THAT HAD NO CEMENT, THE REST OF IT HAD BONE AND CEMENT ATTACHED TO IT. DOI: 2015. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10160922 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND EFFUSIONS. ALL COMPONENTS WERE EXPLANTED AND NEW COMPONENTS PUT IN. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9588612 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LEFT KNEE REVISED DUE TO ARTHROFIBROSIS SECONDARY TO TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT, TIBIAL INSERT AND THE TIBIAL TRAY WERE REMOVED. THE PATELLA WAS RETAINED. CEMENT COMPETITOR WAS USED. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9584715 ↗