ATTUNE 1516-20-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10603295045649), received between Aug 11, 2017 and Jun 4, 2026 — classified as 77 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 84 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 THE DOCTOR PERFORMED A COMPLETE REVISION TODAY FOR ARTHOFIBROSIS. PATIENT SLOWLY LOST MOBILITY UNTIL KNEE WAS VERY STIFF. DURING REMOVAL OF THE TIBIAL COMPONENT IT WAS NOTED THAT THERE WAS CEMENT DEBONDING BETWEEN THE IMPLANT AND THE CEMENT. THIS WAS THE FIRST GENERATION ATTUNE TIBIAL COMPONENT. NO SURGICAL DELAY. REVISION WAS PERFORMED WITHOUT ISSUE. NOTHING ELSE TO REPORT. IT WAS STATED THAT TIBIAL COMPONENT WAS 1ST GEN ATTUNE TIBIAL BASEPLATE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. COMPETITOR CEMENT WAS USED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 25394013 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Muscular Rigidity

  MAUDE report 24972651 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS PAIN AND TIGHTNESS IN THE KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24815461 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION FOR PAIN.

  Patient problems: Pain

  MAUDE report 23924282 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A LEFT TOTAL KNEE DONE (B)(6) 2022. SINCE THEN THE PATIENT HAS EXPERIENCED SOME INSTABILITY MOSTLY ON THE LATERAL SIDE AND HAS BECOME LOOSE. SURGEON WANTED TO DO A POLY EXCHANGE. ALL THE IMPLANTS WERE WELL FIXED AND EVERYTHING LOOKED GOOD. SURGEON ALSO PUT IN A MEDIAL STABILIZED POLY 8 MM AND IT CORRECTED THE ISSUES. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23838034 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEW REVISION DUE TO TIBIA CUT MADE IN VALGUS. PATIENT UNHAPPY WITH ALIGNMENT. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770272 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS LOOSE AND WENT TO THICKER INSERT. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23610138 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON STATES PATIENT COMPLAINED OF GLOBALLY LOOSE ATTUNE KNEE. REMOVED A 5MM POLY AND EXCHANGED IT FOR A 10MM POLY. DOI- (B)(6) 2021. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23578197 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D POLY SWAP DUE TO INFECTION. AFFECTED SIDE-LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23573202 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LOOSE KNEE WENT TO THICKER POLY. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23351290 ↗
• InjurySep 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT WAS HIT WITH A CAR. LEFT KNEE HAD PREVIOUSLY BEEN REPAIRED BEFORE THE ACCIDENT. APPROXIMATELY 1 YEAR AFTER THE ACCIDENT, THE ATT KNEE INLAY NEEDED TO BE REMOVED DUE TO DEVICE LOOSENING. UPON REVISION THE PE INLAY SHOWED DISCOLORATION. NO SURGICAL DELAY DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 22983589 ↗
• InjuryJul 16, 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 KNEE INSTABILITY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22518766 ↗
• MalfunctionJun 9, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, THE GASKET CANNOT BE INSERTED. COULD NOT LOCK THE INSERT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE SURGERY DELAYED FOR FIVE MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167345 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. THE POLY WAS SWAPPED. THERE WAS NO ALLEGATION AGAINST THE PRODUCT. THERE WAS NO PATIENT CONSEQUENCES RELATED TO THIS EVENT. THERE WAS NOT A SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20169032 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED REVISION WAS COMPLETED DUE TO INFECTION. SURGEON PERFORMED I&D AND REPLACED POLY. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19653988 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2013. DATE OF EVENT: 15 AUG 2016. (LEFT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 19220587 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED TIBIA DUE TO GLOBAL INSTABILITY OF KNEE. PATIENT HAD NO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19114720 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18731396 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 18465468 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND NO ABNORMAL OR IDENTIFIABLE DAMAGE TO THE EXPLANTED IMPLANT.

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

  MAUDE report 18055141 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SEEN FOR A SWOLLEN AND INFECTED KNEE. SURGEON WASHED OUT AND THEN SWAPPED OUT THE INSERT POLY. POLY HAD NO WEAR, NO ISSUES AND NO OTHER ISSUES OR ABNORMALITIES WERE NOTICED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 18046765 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEW POLY IMPLANTED DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN . DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17744473 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION DUE TO PAIN AND STIFFNESS. THE PATIENT'S KNEE WAS REVISED UNEVENTFULLY AND NO PATIENT HARM OCCURRED. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 17351326 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION, ALL IMPLANTS WERE TAKEN OUT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17051892 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE REVISION FOR FEMORAL COMPONENT BEING IMPLANTED IN TO MUCH FLEXION IN 2016. COMPONENTS WERE REMOVED AND ATTUNE REVISION WAS PUT IN. PLEASE NOT THE PATELLA WAS LEFT IN SITU.

  Patient problems: Joint Laxity

  MAUDE report 16831454 ↗