ATTUNE 1517-10-718Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295056188), received between May 27, 2021 and Feb 5, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Unintended Movement

  ADDITIONAL INFORMATION RECEIVED: WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. - YES. THEY NEEDED A REVISION.

  Patient problems: Insufficient Information

  MAUDE report 24267956 ↗
• InjuryNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY SWAP FOR INSTABILITY AND INSERT DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23561187 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELT UNSTABLE. PLAN IS FOR SWAPPING POLY RP INSERT TO THICKER POLY IMPLANT DUE TO INSTABILITY. DOI: (B)(6) 2023. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22372555 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT POLY SWAP FOR INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21420697 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION AND THEY PUT IN A PROSTALAC SPACER. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16402842 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DAIR PROCEDURE FOR INFECTION. PRIMARY SURGERY EARLY 2021, DR (B)(6) HOSP. PROCEDURE TODAY DAIR PROCEDURE FOR INFECTION DR (B)(6) WHO DOES NOT APPEAR ON CST LIST. DOI: 2021, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12533928 ↗
• InjuryMay 27, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT IN (B)(6) 2020, THE PATIENT UNDERWENT INITIAL TKA SURGERY ON KNEE FOR SUBLUXATION WITH OTHER COMPANY'S PRODUCTS. IN (B)(6) 2021, THE IMPLANT WAS REMOVED DUE TO INFECTION, AND A CEMENT MOLD CONTAINING ANTIBIOTICS WAS PLACED. IN (B)(6) 2021, TKA REOPERATION WAS PERFORMED (DEPUY/ATTUNE REVISION/RP) WITH THE IMPLANTS. ON (B)(6) UNKNOWN DATE, 2021, SPIN-OUT OCCURRED. ON (B)(6) 2021, THE RP TIBIAL TRAY WAS REMOVED AND REPLACED WITH AN FB TIBIAL TRAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11893886 ↗