ATTUNE 1504-11-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295042068), received between Jan 31, 2019 and Jul 27, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Osseointegration Problem

  It was reported that patient underwent an Endo genus dextri (right side) - ATTUNE CEMENTLESS surgery on (b)(6) 2024. After the surgery, they experienced constant pain and had an unsteady gait.According to product specifications, when properly implanted, the components fuse with the bones of the knee within eight weeks. Following examinations and imaging studies, it was determined that the joint components were not in place; the patella was outside the femoral groove of the joint (Patela Bata), and the leg had been displaced to the right and outward.The surgeon recommended physical therapy, but the problem was not resolved. They then recommended operation only on the knee cap. After consultations with other orthopedic surgeons and imaging studies, it was determined that the patella (kneecap) and the joint were not aligned. The joint had been positioned further inward, while the patella was 1 cm to the right and did not fit into the femoral canal. Revision surgery occurred on (b)(6)14, 2025, fourteen months after initial endoprosthetic replacement. It was determined that osseointegration had not occurred. There was no sign of bone on the implants; they were removed extremely easily,

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 50037063 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO KNEE INFECTION . COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21410187 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE CEMENTLESS IMPLANTS WERE REMOVED DUE TO INFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18769376 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS IMPLANTED TO STAGE INFECTION. NO OTHER INFORMATION WAS GIVEN. THE CEMENT MANUFACTURER WAS NOT INDICATED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16252148 ↗
• InjurySep 23, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT HAS A RIGHT TOTAL PRESS FIT ATTUNE KNEE. THE PATIENT HAS START UP PAIN. ALL OTHER OPTIONS WERE TRIED. THE SURGEON BELIEVES THAT THE FEMORAL COMPONENT IS LOOSE. THE FEMUR WAS REVISED. IT WAS VERY DIFFICULT TO REMOVE THE FEMUR. AFTER REMOVAL, IT IS NOTICED THAT THE FEMUR JUST HAD FIBROUS GROWTH. THE SURGEON WAS ABLE TO PEEL THE TISSUE OFF THE BACKSIDE OF THE FEMORAL COMPONENT. THE TIBIAL TRAY WAS WELL FIXED AND RETAINED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE. ADDITIONAL INFORMATION: US-FDA MDR REPORTABILITY DETERMINATION: A KNEE WAS REVISED TO ADDRESS IMPLANT LOOSENING OF THE POROUS COATED FEMUR COMPONENT. ALTHOUGH THE COMPLAINT DESCRIPTION STATED LOOSENING OCCURRED AT THE BONE TO CEMENT INTERFACE, THIS IS CLEARLY IN ERROR, AS THE REMAINDER OF THE REPORT INDICATES THAT IT IS A POROUS COATED FEMUR (NOT CEMENTED) AND THAT THE FEMUR HAD ONLY FIBROUS INGROWTH, WITH TISSUE BEING ABLE TO BE PEELED DIRECTLY OFF OF THE BACK OF THE FEMUR IMPLANT. GIVEN THIS, WE CAN EXCLUDE BONE CEMENT FROM THE REPORT, AND FOCUS ON THE FEMUR. NO OTHER KNEE

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15469788 ↗
• MalfunctionApr 14, 2022Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  ATTUNE CEMENTLESS FEMUR CAUSED PROBLEMS WHEN IMPACTED. THE SURGEON WAS UNABLE TO COMPLETE HIS IMPACTION IN ORDER TO AVOID A POTENTIAL FRACTURE OF THE PATIENT'S FEMUR. FOR SOME TIME NOW, HE HAS NOTICED TOO MUCH PRESS-FIT, SO HE HAD TO PUT IN A FEMUR TO BE CEMENTED. THERE WAS A 30 MINUTE DELAY IN THE CASE. A SECOND COMPLAINT WAS RECORDED REGARDING THE RECURRENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110802 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 11117511 ↗
• MalfunctionAug 12, 2019Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLOFEMORAL CREPITUS/ MILD PATELLAR CLUNK (WITHOUT PAIN), EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8883455 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR FREQUENT POPPING TO POSTEROLATERAL RIGHT KNEE, POSSIBLE POPLITEUS SCARRING.

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Pain; Scarring; Swelling

  MAUDE report 8292428 ↗