ATTUNE 1516-30-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295048022), received between Oct 25, 2018 and Feb 23, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED PAIN SO IT WAS DECIDED TO REMOVE EVERYTHING AND REPLACE WITH ATTUNE REVISION COMPONENTS. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24413929 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENTS RECEIVED FOR ADHESIONS: DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: REMOTE POSSIBILITY, PROCEDURE RELATED: PROBABLY, DATE OF EVENT: 15/DEC/2024, DATE OF IMPLANT: ON (B)(6) 2024, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 21600037 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6); STUDY NO: DPO_10004_10008. CLINICAL ADVERSE EVENT RECEIVED FOR ANTERIOR KNEE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2015; DATE OF EVENT: (B)(6) 2023; (RIGHT KNEE). TREATMENT: MEDICAL INTERVENTION/MODIFICATION (NOT SPECIFIED) AND PHYSICAL THERAPY.

  Patient problems: Pain

  MAUDE report 18433949 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17913720 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATENT WAS REVISED DUE TO INFECTION. POLY SWAP WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15978995 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE DUE TO INFECTION. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15969094 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LEFT ATTUNE TKR IN (B)(6) 2022. PRESENTED BACK TO SURGEON COMPLAINING OF STIFFNESS IN KNEE, UNABLE TO GET FULL EXTENSION AND FLEXION. 10MM POLY IN SITU. PROCEDURE LEFT KNEE EXPLORATION, DEBRIDEMENT AND REVISION OF POLY. SURGEON DOWNSIZED POLY TO 7MM, SATISFIED WITH ROM AND STABLILITY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 15595100 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POLY LINER EXCHANGE DUE TO INSTABILITY. THE SURGEON INCREASED FROM A 10MM INSERT TO A 16MM. THERE WERE NO INDICATIONS OF A DEFICIENCY WITH THE PRODUCT. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14577660 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11983553 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11372888 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFF RIGHT TKA : ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: RIGHT KNEE MANIPULATION UNDER ANESTHESIA: (B)(6) 2020.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 10928596 ↗
• InjuryOct 25, 2018Unstable; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Unstable; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  LITIGATION RECEIVED. REVISION DUE TO PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 8006409 ↗