ATTUNE 1517-10-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295055976), received between Oct 8, 2020 and Mar 9, 2026 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE I&D INSERT EXCHANGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24545253 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY EXCHANGE DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22860340 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASH OUT WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21458760 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) OF HER RIGHT KNEE DUE TO INFECTION. THE POLY WAS REMOVED TO ACCESS THE POSTERIOR PORTION OF THE JOINT FOR DEBRIDEMENT. AT THAT TIME IT WAS NOTED THAT ALL OTHER IMPLANTS WERE WELL FIXED. A NEW POLY WAS PLACED. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17689022 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A REVISION FOR INSTABILITY. IMPLANTATION OCCURRED ON THE (B)(6) 2022. THIS WAS THE PATIENT'S FIRST REVISION, THEY HAVE COMPETITOR PRODUCTS PUT IN DURING THE PRIMARY PROCEDURE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17058449 ↗
• InjuryJan 11, 2023Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  PATIENT UNDERWENT REVISION RIGHT ATTUNE KNEE REPLACEMENT IN (B)(6) 2022. PRESENTED BACK TO SURGEON COMPLAINING OF PAIN AND LOSS OF MOVEMENT. SURGEON STATES PATIENT DESCRIBES TRYING TO STAND FROM A SITTING POSITION AND HYPERFLEXING HER KNEE, FELT PAIN AND LOSS OF MOVEMENT AS SHE WENT TO STAND. X-RAYS SUSPECTED DISLOCATION OF POLY INSERT. PROCEDURE TODAY, REVISION OF POLY INSERT, 5/20MM REMOVED AND UPSIZED TO 5/26MM.

  Patient problems: Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 16136645 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PREVIOUS ATTUNE REVISION PERFORMED ON (B)(6) 2022 AT (B)(6). HAS PRESENTED AS INFECTED, WAS TRANSFERRED TO HUTT VALLEY DHB WITH SOME ASSOCIATED SKIN COMPROMISE, WILL NEED PLASTIC SURGERY POTENTIALLY IF FREE FLAP OF SKIN REQUIRED, THIS IS THE REASON FOR TRANSFER TO (B)(6). PROCEDURE TODAY WAS A WASH OUT AND DEBRIDEMENT WITH EXCHANGE OF POLYETHYLENE INSERT. DOI: (B)(6) 2022, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 14268829 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S PREVIOUSLY REVISED KNEE WAS REVISED A SECOND TIME DUE TO PAIN AND INSTABILITY. THE PATIENT'S ATTUNE REVISION KNEE COMPONENTS WERE REMOVED AND REPLACED BY AN S-ROM NOILES HINGED FEMUR, AN LPS HINGED RP INSERT, AND A SIGMA REVISION MBT TIBIAL TRAY. DEPUY SMARTSET MEDIUM VISCOSITY BONE CEMENT WOULD HAVE BEEN USED IN THE PRIOR REVISION PROCEDURE, SINCE THE HOSPITAL ONLY STOCKS SMARTSET CEMENT. THE PRODUCT CODES AND LOT NUMBERS FOR THE CEMENT IS NOT AVAILABLE, SINCE THE CEMENT USED WAS HOSPITAL INVENTORY ORDERED DIRECTLY FROM DEPUY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13170583 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED THAT THE PATIENT WAS NOT EXCEPTIONALLY HEALTHY AND THAT THE JOINT WAS INFECTED. HE WANTED TO SWAP OUT THE CURRENT POLY (SIZE 5 20MM CRS ATTUNE REVISION) FOR THE SAME SIZE. AFTER EXPLANTING POLY, IMPLANTATION OF SIZE 5 20MM CRS ATTUNE REVISION RP POLY WAS DONE. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10649791 ↗