ATTUNE 1504-01-126Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295041436), received between Jan 14, 2020 and Jun 24, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Osseointegration Problem

  IT WAS REPORTED THAT SURGEON BELIEVED FEMUR COMPONENT WAS LOOSE. REMOVED AND REPLACED WITH ATTUNE REVISION FEMUR. DOI: (B)(6) 2025, DOR: (B)(6) 2026 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25609459 ↗
• InjuryMay 21, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD POOR BONE QUALITY, AND THEIR LATERAL FEMORAL CONDYLE COLLAPSED DURING A FALL. THE IMPLANT HAD NOTHING TO ATTACH TO LATERALLY. THERE WAS NON-CEMENTED LOOSENING OF THE FEMUR. SURGEON PUT IN A REVISION FEMUR AND INSERT. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 22059316 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AFFECTED SITE WAS THE LEFT SIDE. THE FRACTURED PART WAS THE FEMORAL BONE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 18325565 ↗
• InjuryFeb 21, 2020Loss of Osseointegration; Loss of Osseointegration

  PRIMARY ATTUNE TOTAL KNEE IMPLANTED DUE TO OSTEOARTHRITIS OF THE LEFT KNEE. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X 1 WAS UTILIZED. THERE WERE NO SURGICAL OR POSTOPERATIVE COMPLICATIONS REPORTED. REVISION OF THE LEFT KNEE DUE TO LOOSENING OF THE TIBIAL TRAY. INTRAOPERATIVELY, THE SURGEONS FOUND LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENT AT THE IMPLANT TO BONE INTERFACE AS EVIDENCED BY FIBROUS INGROWTH AND EASY REMOVAL. THE PATELLAR COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT WAS REVISED WITH DEPUY COMPONENTS AND DEPUY CEMENT X2. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9739401 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND EFFUSIONS. ALL COMPONENTS WERE EXPLANTED AND NEW COMPONENTS PUT IN. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9588598 ↗