ATTUNE 1504-10-223Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295041825), received between Apr 8, 2019 and Jun 8, 2022 — classified as 5 injuries, 1 malfunction.

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

• MalfunctionJun 8, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PLASTIC PACKAGE MELTED ON THE TEXTURE OF THE IMPLANT, OBSERVED BEFORE IMPLANT. SURGEON CHANGED NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632547 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE AND PAIN. DOI: (B)(6) 2018 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10414293 ↗
• InjuryOct 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 27 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY AND A REVISION OF THE LEFT UNI-COMPARTMENTAL ARTHROPLASTY. THIS PC PERTAINS TO THE RIGHT KNEE. THE SURGEON UTILIZED DEPUY COMPONENTS AND TWO DEPUY CEMENTS. NO COMPLICATIONS WERE NOTED IN THE SURGICAL NOTES. ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION OF THE ATTUNE POSTERIOR STABILIZED ROTATING PLATFORM TO A SIGMA TC3 ROTATING PLATFORM COMPONENT WITH METAPHYSEAL SLEEVES TO ADDRESS AN UNSTABLE RIGHT KNEE. THE SURGEON REPORTED THAT TIBIAL COMPONENT HAD SUBLUXED POSTERIORLY DISENGAGING THE POSTERIOR POST. THE SURGEON NOTED THAT THE ROTATIONAL INSTABILITY WAS OF UNKNOWN ETIOLOGY AND DECIDED TO REMOVE BOTH THE FEMUR AND TIBIAL COMPONENTS. THERE WAS A CRACK NOTED IN THE MEDIAL CONDYLE OF THE FEMUR, WHICH WAS ¿FIXED¿ WITH 7.3 CANCELLOUS SCREW. DEPUY COMPONENTS WERE PLACED ALONG WITH 2 SMARTSET CEMENTS DURING THE REVISION. DOI: (B)(6) 2015; DOR: (B)(6) 2015; (RT KNEE).

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

  MAUDE report 9210054 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE OF THE DISTAL FEMUR. DOI: (B)(6) 2019. DOR: (B)(6) 2019; RIGHT KNEE.

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

  MAUDE report 9088055 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY- RT 3N PS FEMUR - REF. 150410223, LOT: 460021; SZ 3 TIBIAL TRAY - REF. D150600003, LOT: 8175579; SZ 3 PS 5MM POLY INSERT - REF. 151640305, LOT: 462941; CEMENT USED: CMW 2 - REF. 3325040 LOT 8235. DATE OF SURGERY: (B)(6) 2016. REVISION SURGERY.

  Patient problems: No Code Available; Pain

  MAUDE report 8903526 ↗
• InjuryApr 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED (B)(6) 2019 AND WERE REVIEWED (B)(6) 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015 , THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY AND A REVISION OF THE LEFT UNI-COMPARTMENTAL ARTHROPLASTY. THIS PC PERTAINS TO THE RIGHT KNEE. THE SURGEON UTILIZED DEPUY COMPONENTS AND TWO DEPUY CEMENTS. NO COMPLICATIONS WERE NOTED IN THE SURGICAL NOTES. ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION OF THE ATTUNE POSTERIOR STABILIZED ROTATING PLATFORM TO A SIGMA TC3 ROTATING PLATFORM COMPONENT WITH METAPHYSEAL SLEEVES TO ADDRESS AN UNSTABLE RIGHT KNEE. THE SURGEON REPORTED THAT TIBIAL COMPONENT HAD SUBLUXED POSTERIORLY DISENGAGING THE POSTERIOR POST. THE SURGEON NOTED THAT THE ROTATIONAL INSTABILITY WAS OF UNKNOWN ETIOLOGY AND DECIDED TO REMOVE BOTH THE FEMUR AND TIBIAL COMPONENTS. THERE WAS A CRACK NOTED IN THE MEDIAL CONDYLE OF THE FEMUR, WHICH WAS ¿FIXED¿ WITH 7.3 CANCELLOUS SCREW. DEPUY COMPONENTS WERE PLACED ALONG WITH 2 SMARTSET CEMENTS DURING THE REVISION. DOI: (B)(6) 2015 , DOR: 21 DECEMBER 2015 (RT KNEE).

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

  MAUDE report 8490982 ↗