ATTUNE 1504-11-208Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295042075), received between Mar 21, 2021 and Mar 11, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED; IMPLANTS REMOVED BECAUSE OF INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24570297 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6), 2025. THE PATIENT FELL AND COMPLAINED ABOUT HIS KNEE HURTING. THE PATIENT HAD DAMAGED HIS TIBIA WHICH CAUSED THE TIBIA IMPLANT TO LOOSEN. THE DOCTOR DECIDED THAT A FULL KNEE REVISION KNEE WAS NEEDED FOR STABILITY.

  Patient problems: Bone Notching; Fall; Joint Laxity; Pain

  MAUDE report 22457002 ↗
• MalfunctionMar 12, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT UPON OPENING THE ATTUNE FEMORAL POROCOAT POSTERIOR STABILISED, SIZE 8, RIGHT, CEMENTLESS, DEFINITIVE IMPLANT AND PLASTIC CONTAINERS WERE STUCK TOGETHER. SURGEON HAD TO USE A SCALPEL TO CUT THROUGH THE STERILE PAPER TO GET THE IMPLANT OUT. SURGERY WAS DELAYED BY TWO MINUTES, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586976 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19231109 ↗
• InjuryAug 23, 2023Off-Label Use; Osseointegration Problem; Off-Label Use; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD RIGHT TKA AT DIFFERENT FACILITY ON (B)(6) 2022. SURGEON STATES PATIENT HAS HAD PAIN SINCE SURGERY. ON (B)(6), 2023 PATIENT WAS REVISED FOR PAINFUL AND LOOSE FEMORAL COMPONENT. PATELLA WAS RETAINED. ALL OTHER COMPONENTS WERE REMOVED. CONE WAS UTILIZED ON FEMORAL SIDE, THE SMALL CONCENTRIC CONE IS NOT COMPATIBLE WITH THE 16 X 110 STEM THAT WAS UTILIZED. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17603699 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC PAIN AND DISCOMFORT. SEVERAL TEST FOR INFECTION THROUGHOUT THE YEAR AND ALL NEGATIVE. THE SURGEON REVISED THE KNEE. REMOVED ALL COMPONENTS EXCEPT PATELLA AND REVISED THE KNEE. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 12318451 ↗
• MalfunctionMay 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAS A TOTAL ATTUNE PRESSFIT KNEE. WHEN THE PATIENT CAME IN FOR HIS 6-MONTH FOLLOW-UP, THE SURGEON NOTICED BEADS THAT HAVE COME OFF FROM THE FEMORAL COMPONENT. THE PATIENT HAS NO SYMPTOMS. THE SURGEON BELIEVED THAT THE BEADS CAME OFF DURING INSERTION OF THE IMPLANT. A PICTURE FROM THE SURGEON CAN BE SENT WHEN NEEDED. DOI: (B)(6), 2020, DOR: (B)(6), 2021, RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801620 ↗
• InjuryMar 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A PRESSFIT ATTUNE RP PS CONSTRUCT IN SEPTEMBER. THE KNEE INITIALLY DID WELL UNTIL THE PATIENT STARTED TO EXPERIENCE GLOBAL PAIN AROUND THE KNEE. THE PATIENT WAS CONFIRMED FOR NICKEL ALLERGY. ALL IMPLANTS WERE REMOVED EXPECT FOR THE PATELLA. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 11536867 ↗