ATTUNE 1517-10-414Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295055839), received between Apr 16, 2021 and Dec 11, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED THICKER POLY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Insufficient Information

  MAUDE report 20904150 ↗
• InjuryAug 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS REVISED TO A COMPETITIVE KNEE SYSTEM AND THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT SIDE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20107127 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16752556 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT HAS BEEN CREATED IN RELATION TO AEI NOTE (B)(4) UNDER (B)(4) TO REPORT AND EVENT POST LEFT KNEE REVISION ON (B)(6) 2022, PATIENT HAS A LEFT DVT IN THE LEFT DFV THAT IS TREATED WITH ORAL BLOOD THINNERS. DOI:(B)(6) 2022. DOR: UNKNOWN. LEFT KNEE SECOND COMPLAINT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16627394 ↗
• InjuryDec 1, 2021Unintended Movement; Unintended Movement

  PATIENT HAD UNDERGONE PRIMARY KNEE , A CONSTRAINED PROSTHESIS WAS CHOSEN BUT HAD SPUN OUT ON (B)(6) 2021 DUE TO COMPROMISED SOFT TISSUES. THIS WAS REVISED TO A HINGE TO SOLVE THE INSTABILITY ON 13TH. DOI: (B)(6) 2021; DOR: (B)(6) 2021 UNKNOWN SIDE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 12910331 ↗
• InjuryApr 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD SOME SUDDEN INSTABILITY DUE TO THE POLY DISLOCATING. A THICKER POLY WAS IMPLANTED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11678136 ↗