ATTUNE 1516-20-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295045571), received between Mar 8, 2018 and Sep 2, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 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 INFECTED LEFT KNEE. INCISION AND WASHOUT WERE PERFORMED, AND THE TIBIAL INSERT SWAPPED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22936430 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINS OF PAINFUL TKA WITH INSTABILITY NOTED ON EXAM. A THICKER INSERT TRIAL WAS ATTEMPTED WHICH ADDRESSED THE INSTABILITY, HOWEVER, THE PATIENT HAD SIGNIFICANT PATELLA BAJA RENDERING THE KNEE TO BE UNACCEPTABLE IN THE SURGEONS OPINION. ALL COMPONENTS WERE REMOVED, JOINT LINE WAS SHIFTED DISTALLY AND REVISION TOOK PLACE UNEVENTFULLY. NO PATIENT HARM OCCURRED. THE INDEX PROCEDURE WAS PERFORMED WITH TRUMATCH GUIDES. ALL COMPONENTS WERE APPROPRIATELY SIZED, ALIGNED AND WERE WELL FIXED. NO POLY WEAR WAS NOTED. NO DELAY OCCURRED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18030964 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALL. PATELLA SHEERED OFF PEGS. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SID: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 17888909 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFF KNEE AND WAS UNABLE TO BEND HER KNEE SO THE SURGEON REPLACED THE IMPLANTS WITH A REVISION IMPLANT. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 16459444 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, MILD FLEXION INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AT BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. ALL PARTS WERE REMOVED EXCEPT THE PATELLA. A NEW TC3 WAS IMPLANTED AND SHE HAD A FULL RANGE OF MOTION FROM FLEXION TO FULL EXTENSION. DOI: (B)(6) 2015. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10763396 ↗
• InjuryMar 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED TOTAL KNEE, THAT WAS REVISED TO AN ARTICULATING SPACER ON (B)(6) 2017. DOI: UNKNOWN; DOR: (B)(6) 2017.

  Patient problems: Unspecified Infection

  MAUDE report 7323635 ↗