ATTUNE 1516-20-807Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295046028), received between Dec 14, 2017 and Apr 27, 2026 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INSTABILITY. DOI-(B)(6) 2023. DOR-(B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25002078 ↗
• InjuryDec 9, 2025Adverse 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) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23755458 ↗
• MalfunctionJan 11, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE FIXED BEARING POLY WOULD NOT SEAT POSTERIOR. IT WOULD NOT ENGAGE INTO THE LOCKING MECHANISM. UNKNOWN SURGICAL DELAY. DOE: JAN 4, 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18493691 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO JOINT STIFFNESS. POLY SWAP WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Muscular Rigidity

  MAUDE report 18228749 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT OF AN ATTUNE CR FB CONSTRUCT DUE TO INFECTION. THE POLY WAS REMOVED, AND A NEW ONE WAS IMPLANTED AFTER THE SITE WAS THOROUGHLY CLEANED AND DEBRIDED. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18173007 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 18011518 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AFFECTED SITE WAS ON THE RIGHT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17218159 ↗
• MalfunctionJul 28, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DEFINITIVE ATTUNE TIBIAL INSERT FIXED BEARING CRUCIATE RETAINING SIZE 8 7MM AOX POLYETHYLENE WOULD NOT LOCK ONTO THE FIXED BEARING TIBIAL BASE PLATE AFTER SEVERAL IMPACTIONS. IT WOULD KEEP MOVING THEREFORE OPENED ANOTHER OF THE SAME IMPLANT AND THIS IMPLANTED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121996 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DECREASED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6).2021, (LEFT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 13549474 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10671965 ↗
• InjuryJul 31, 2020Noise, Audible; Noise, Audible

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. PATIENT REPORTEDLY HEARD A ¿POP¿ IN HIS KNEE. THE SURGEON THOUGHT IT MIGHT BE QUAD RUPTURE, BUT THE QUAD WAS INTACT ALTHOUGH A LITTLE STRETCHED. A 3MM THICKER POLY WAS USED TO OBTAIN STABILITY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10351943 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS POOR RANGE OF MOTION. FEMUR WAS REVISED. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

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

  MAUDE report 9849114 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. I & D WASHOUT AND POLY SWAP WAS DONE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9647943 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. 8 X 7 MM ATTUNE CR FB INSERT WAS REMOVED AND REPLACED WITH A THICKER INSERT. DOI: (B)(6) 2016. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9147285 ↗
• InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE PAIN, RECURRENT EFFUSIONS, INSTABILITY, AND SYNOVITIS. THE SURGEON NOTED ALL COMPONENTS WERE WELL-FIXED. THE PATELLA COMPONENT WAS NOT REVISED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016. DOR: (B)(6) 2017, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8884614 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON PERFORMED A WASHOUT AND INSERT CHANGE DUE TO POSSIBLE INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8536891 ↗
• InjuryDec 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT FELL AND EXPERIENCED PAIN WITH EDEMA ON THE LEFT LEG. IT WAS ALSO INDICATED THAT THE PATIENT UNDERGONE I&D.DOI: (B)(6) 2017; DOR: (B)(6) 2017 LEFT KNEE.

  Patient problems: Edema; Pain

  MAUDE report 7116593 ↗