ATTUNE 1516-40-407Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295049807), received between Dec 11, 2017 and Feb 2, 2026 — classified as 42 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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 43 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH UNSTABLE KNEE AND WAS REVISED TO A THICKER POLY. DOI: (B)(6) 2020. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24239525 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED RIGHT TOTAL KNEE. I&D WITH POLY EXCHANGE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22331038 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR INSTABILITY. IMPLANTS WERE REMOVED AND AN ATTUNE REVISION WAS PLACED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22010453 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER PUT IN. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19647356 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY IN THE KNEE; NEEDED A THICKER POLY. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18988064 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18791467 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6), 2021. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18319007 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17397503 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17217962 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR MEDIAL COLLAPSE OF THE TIBIA DUE TO LOOSENING AT CEMENT TO IMPLANT INTERFACE. TIBIAL TRAY WAS REMOVED AND NO CEMENT WAS PRESENT ON THE TRAY. PATIENT WAS REVISED WITH A MEDIAL 10MM AUGMENT. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2015. DOR- (B)(6) 2022 AFFECTED SIDE- LEFT KNEE.

  Patient problems: Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 17142537 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15931656 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED KNEE DUE TO LOOSENING OF FEMUR AND TIBIA AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 15636480 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIBIAL SUBSIDENCE AND POOR BONE QUALITY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15503498 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CALL FROM A CUSTOMER WAS RECEIVED STATING THAT "I WANT TO KNOW WHO I CAN TALK ABOUT MY KNEE REPLACEMENT. I'M HAVING A PROBLEM WITH IT AND IT'S BEEN RECALLED EVEN BEFORE MY DOCTOR PUT IT IN ME. AND SINCE THEN I START TO HAVE PROBLEM WITH IT. SHOULD I CALL A LAWYER FOR THE COMPENSATION?" DOI: (B)(6) 2019; DOR: (B)(6) 2020; UNKNOWN KNEE.

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

  MAUDE report 15281841 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO REDNESS AT INCISION SITE. THE SURGEON WENT IN FOR I&D, AND INFECTION WAS IN THE JOINT. THE PHYSICIAN PERFORMED A POLY SWAP AFTER I&D. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 14696933 ↗
• MalfunctionJun 8, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A TKA SURGERY. THE SURGEON DROVE THE INSERT IN QUESTION INTO THE PREDETERMINED POSITION, IT COULD NOT BE LOCKED SINCE THERE WAS A GAP BETWEEN THE INSERT AND A TIBIAL TRAY. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 14631026 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE SWELLING. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (RIGHT KNEE). TREATMENT: ASPIRATION AND DRAINAGE, KNEE BRACE.

  Patient problems: Swelling/ Edema

  MAUDE report 14194080 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14167299 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 13506685 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMARY OPERATIVE NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND COMPETITOR CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS ASEPTIC LOOSENING, RIGHT TOTAL KNEE. THE INDICATIONS FOR SURGERY INCLUDED PAIN AND LOSS OF MOTION AND FUNCTION. DURING THE PROCEDURE THE SURGEON NOTED THAT THE TIBIAL TRAY WAS GROSSLY LOOSE AT THE TRAY/CEMENT INTERFACE. THE FEMORAL AND INSERT COMPONENTS WERE REVISED WITHOUT ALLEGATION OF DEFICIENCY. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE DOI: (B)(6) 2017; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12149912 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, STIFFNESS, FLEXION CONTRACTURE, EXTENSIVE SCAR TISSUE AND LOOSENING. UPON ENTERING THE JOINT, THE TIBIAL COMPONENT WAS IDENTIFIED AT LOOSE AT THE CEMENT TO IMPLANT INTERFACE. ALL IMPLANTS WITH THE EXCEPTION OF THE PATELLA WERE REVISED. NO INDICATION OF PRODUCT DEFICIENCY RELATED TO THE FEMORAL, INSERT OR PATELLA COMPONENTS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Contracture; Muscular Rigidity; Pain

  MAUDE report 11995195 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FEMORAL REVISION DUE TO EXCESSIVE SCAR TISSUE FORMATION AND POOR RANGE OF MOTION. NO LOOSENING REPORTED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 11826466 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY AND LOOSENING OF TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. NO DELAY IN SURGERY REPORTED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11574336 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PATELLA SUBLUXATION. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11568517 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INABILITY TO STRAIGHTEN HER KNEE. SURGEON REMOVED THE SCAR TISSUE FROM THE KNEE THROUGH AN OPEN PROCEDURE. ALSO REPLACED THE PATIENT'S PRIMARY ATTUNE SIZE 4 FB PS 7MM TIBIAL INSERT WITH A THINNER SIZE 4 FB PS 5MM TIBIAL INSERT, TO INSURE HER KNEE WOULD FULLY EXTEND. THE SURGEON WHO PERFORMED THE PATIENT'S PRIMARY KNEE REPLACEMENT SURGERY. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11436103 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507