ATTUNE 1504-11-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295042044), received between Jul 16, 2020 and Feb 27, 2024 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Loss of Range of Motion

  MAUDE report 18789903 ↗
• InjuryOct 2, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE BONE TO IMPLANT INTERFACE. SURGEON INITIALLY THOUGHT PATIENT NEEDED A LARGER POLY BECAUSE OF A LITTLE FLEXION INSTABILITY, BUT THEN DISCOVERED FEMUR WAS SLIGHTLY LOOSE, REVISED ENTIRE KNEE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 17853891 ↗
• InjuryMay 30, 2023Osseointegration Problem; Osseointegration Problem

  REVISION FOR ASEPTIC LOOSENING DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?: REVISION TKA SURGERY, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE : REVISION TKA, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, IP-01734180 DEVICE PROPERTY OF :NONE, DEVICE IN POSSESSION OF :NONE, IP-01734181, DEVICE PROPERTY OF:NONE, DEVICE IN POSSESSION OF: NONE, IP-01734182 DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17023382 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS PAIN. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT, TIBIAL TRAY, FEMORAL COMPONENT, AND DEPUY CEMENT PRODUCT. THE PATELLA COMPONENT WAS RETAINED.

  Patient problems: Discomfort; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 13358499 ↗
• MalfunctionApr 21, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PRESS FIT ATTUNE FEMUR WOULD NOT IMPACT FULLY ONTO THE DISTAL FEMUR. EVEN THOUGH THE CUT ASSESSMENT TOOL WAS USED AND THE COMPOSITE FEMORAL TRIAL FULLY SEATED. THE PROSTHESIS SAT UP ROUGHLY 3-4 MM OFF THE LATERAL DISTAL FEMUR. THE SURGEON DID NOT WANT TO TRY TO REMOVE THE FEMUR AND DECIDED TO LET IT GO. NO SURGICAL DELAY. DOE: (B)(6) 2021, RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703613 ↗
• InjuryJul 16, 2020Unintended Movement; Migration; Unintended Movement; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA FOR THE PATIENT¿S RIGHT KNEE JOINT. AFTER THE SURGERY, DURING REHABILITATION, THE PATIENT HAD A PAIN AND THE SURGEON SEEMED THAT THE FEMORAL COMPONENT (P/N: 150411205)'S MEDIAL SIDE WAS SLIGHTLY SINKING BY X-RAY. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE FEMORAL COMPONENT. DURING THE REVISION SURGERY, THE SURGEON CONFIRMED THAT THE FEMORAL COMPONENT'S MEDIAL SIDE WAS SINKING ABOUT 3MM. AND, WHEN THE SURGEON REMOVED THE FEMORAL COMPONENT, THE BONE OF THE FEMORAL COMPONENT¿S SINKING PART BROKE. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE SURGEON THOUGHT THAT THE MEDIAL FEMUR CRACKED, AND THE FEMORAL BREAKAGE OCCURRED WHEN THE PRIMARY SURGERY, AND THEY CAUSED THE SINKING OF THE FEMORAL COMPONENT AFTER THE PRIMARY SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10284176 ↗