ATTUNE 1504-01-224Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295041559), received between May 3, 2019 and Jan 19, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE) TREATMENT: MANIPULATION UNDER ANESTHESIA COMPLETED ON (B)(6) 2023.

  Patient problems: Adhesion(s)

  MAUDE report 16205279 ↗
• InjuryApr 17, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED A COMPLETE RIGHT KNEE REVISION TO TREAT RECURRENT INSTABILITY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED SIGNIFICANT SCAR TISSUE HAD FORMED ANTERIORLY TO THE INSERT WHICH CAUSED THE INSERT TO ROTATE LESS THAN 90 DEGREES POSTEROMEDIALLY AND NOT BE ABLE TO RETURN TO THE APPROPRIATE POSITION. THE SURGEON ALSO NOTES THE NATURAL PCL AND LCL WERE INSUFFICIENT AND SIGNIFICANTLY LOOSE. ALL COMPONENTS WERE REVISED TO A DEPUY HINGED REVISION SYSTEM INCLUDING A DOMED PATELLA UTILIZING UNKNOWN CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. TIBIAL COMPONENTS: SIZE 2.5 MBT REVISION ROTATING PLATFORM TIBIAL BASEPLATE WITH A SIZE 29 MM MBT METAPHYSEAL POROUS SLEEVE AND A 75 MM LENGTH BY 16 MM DIAMETER UNIVERSAL FLUTED STEM WITH A 21 MM HEIGHT EXTRA-SMALL TIBIAL INSERT. FEMORAL COMPONENTS: SIZE EXTRA SMALL RIGHT ROTATING HINGE CEMENTED FEMORAL COMPONENT WITH A 34 MM FULLY POROUS UNIVERSAL FEMORAL SLEEVE AND A 75 MM LENGTH BY 16 MM DIAMETER UNIVERSAL FLUTED STEM. PATELLA: 35 MM DOMED PATELLA. PART/LOT STICKER SHEET WAS NOT PROVIDED IN THE OPERATIVE NOTES. DOI: (B)(6) 2019; DOI: (B)(6) 2019 (TIBIAL INSERT); DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Dislocation; No Code Available

  MAUDE report 9972553 ↗
• InjuryFeb 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION AND INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9711321 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CEMENTLESS IMPLANTS WERE REMOVED BECAUSE OF INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8578209 ↗