ATTUNE 1504-10-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295041818), received between Dec 3, 2019 and Jun 17, 2025 — classified as 5 injuries, 2 malfunctions.

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

• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS REMOVED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22231239 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE AN INFECTION. SO, SURGEON PULLED ORIGINAL IMPLANTS AND PUT IN A CEMENT SPACER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21936240 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH BILATERAL RESECTIONS DUE TO INFECTIONS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21619267 ↗
• MalfunctionDec 1, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE IMPLANT HAD PART OF THE POLYSTYRENE PACKAGING STUCK TO THE OUTER SURFACE OF THE FEMUR. WAS ABLE TO BE REMOVED TO SURGEON SATISFACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15895330 ↗
• MalfunctionJan 21, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT LAST (B)(6) 2021 A SIZE 10 RIGHT ATTUNE PS CEMENTED FEMUR WAS DEFECTIVE ON THE M/L POSITION OF THE IMPACT. THERE HAD A APPEARED TO BE SOME FLAKY MATERIAL COATED ALONG THE RIDGE OF THE IMPLANT. THE DEFECTIVE IMPLANT WAS SAVED AND PACKAGED PROPERLY IN A HAZARDOUS WASTE BAG. OPENED A NEW FEMUR OF THE SAME SIZE AND KEPT THE DEFECTIVE ON OFF TO THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13313836 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT ADVANCED TRICOMPARTMENTAL OSTEOARTHRITIS OF THE RIGHT KNEE. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. RECORDS INDICATE THE PATIENT RECEIVED A REVISION OF THE RIGHT KNEE. THE INDICATIONS FOR THE REVISION AND THE COMPONENTS REVISED ARE UNKNOWN. THERE WERE NO REVISION OPERATIVE NOTES PROVIDED. DOI: (B)(6) 2016. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9865045 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY AND PAIN. THE SURGEON REPORTED FEMORAL COMPONENT WAS SOLID, THOUGH REVISED. HE NOTED HE FELT CONVERTING THE PATIENT TO A FULL TC 3 DISTAL FEMUR WOULD MATCH UP WITH THE MBT TRAY TO GIVE MORE CONSTRAINT. THE SURGEON INDICATED THE PATELLA TRACKED CENTRALLY AND WAS RETAINED. NEITHER THE TIBIAL NOR PATELLAR COMPONENTS WERE REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY FEMORAL SYSTEM, TIBIAL INSERT, AND UNKNOWN BONE CEMENT. DOI: (B)(6) 2014 (FEMORAL COMPONENTS AND BONE CEMENT); DOI: (B)(6) 2016 (TIBIAL INSERT); DOR: (B)(6) 2017 (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9405101 ↗