ATTUNE 1504-00-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295041184), received between Feb 7, 2018 and Sep 23, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE PRIMARY IMPLANTS. REVISION DUE TO PATIENT PAIN AND CYST FORMATION BEHIND THE FEMORAL IMPLANT. ORIGINAL SURGERY DATE UNKNOWN.

  Patient problems: Cyst(s); Pain

  MAUDE report 20280008 ↗
• InjuryAug 5, 2024Migration; Migration

  REVISION DUE TO FEMUR MOVEMENT.

  Patient problems: Pain

  MAUDE report 19906899 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SUSPECTED INFECTION IS CLAIMED.

  Patient problems: Unspecified Infection

  MAUDE report 17360329 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED BY OUR PATIENT THAT SHE FOUND MY NAME/NUMBER ON FDA¿S RECALL SITE. SHE WANTED TO KNOW IF HER ATTUNE KNEES IMPLANTED IN GERMANY WERE RECALLED. ATTUNE KNEES GERMANY ORIGINAL SURGERY (B)(6) 2014 BILATERAL. REVISION SURGERY IN (B)(6) LEFT SIDE IN 2019 APPROXIMATELY (B)(6) (WAS NOT SUCCESSFUL). REVISION ON LEFT (B)(6) 2020. REVISION SURGERY IN RIGHT IN (B)(6) OF 2021. PATIENT INDICATED SHE UNDERWENT BILATERAL TKAS WITH ATTUNE IMPLANTS ON (B0(6) 2014 IN GERMANY. SHE UNDERWENT A REVISION OF HER LEFT KNEE IN 2019 FOR INSTABILITY AND TIBIAL TRAY LOOSENING (UNKNOWN INTERFACE OR CEMENT MFG INVOLVED). ALL IMPLANTS WERE REMOVED AND ITS UNKNOWN WHAT IMPLANTS (MANUFACTURER) WERE PLACED AS REVISION. SHE UNDERWENT A REVISION OF HER RIGHT KNEE IN (B)(6) OF 2021 FOR INSTABILITY AND TIBIAL TRAY LOOSENING (UNKNOWN INTERFACE FOR CEMENT MFG INVOLVED). ALL IMPLANTS WERE REMOVED AND ITS UNKNOWN WHAT IMPLANTS (MANUFACTURER) WERE PLACED AS REVISION. THE PATIENT IS SEEKING RECALL INFORMATION. PATIENT WAS INFORMED THE PART/LOT INFORMATION OF THE IMPLANTS PLACED IN 2014 IS NEEDED. PATIENT INDICATED SHE HAS THIS INFORMATION AND PROVIDE US WITH THIS INFORMATION. PATIEN

  Patient problems: Joint Laxity

  MAUDE report 16551678 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRA-OP MEDIAL EPICONDYLE FRACTURE, BONE FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE) TREATMENT: INTRA-OP ORIF.

  Patient problems: Limb Fracture

  MAUDE report 14473904 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO SURGICAL DELAY. AFFECTED SIDE WAS THE RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13047664 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TO TREAT SEVERE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X1 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT¿S RIGHT KNEE WAS REVISED TO TREAT PAIN AND INSTABILITY SECONDARY TO SUSPECTED TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED PERIARTICULAR SCAR TISSUE. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION PRODUCTS. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH A COMPETITOR REVISION KNEE CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 12363707 ↗
• InjuryApr 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN AND DECREASED RANGE OF MOTION. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE BOTH LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED REMOVAL OF EXCESSIVE SCAR TISSUE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain

  MAUDE report 11603298 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HYPOPROTEINEMIA: MALNUTRITION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Test Result

  MAUDE report 9468927 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 15 OCTOBER 2019 FOR MDR REPORTABILITY. ON UNKNOWN DATE, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO UNKNOWN DIAGNOSES. THERE WAS NO HISTORY, NOR OPERATIVE NOTES INCLUDED IN THE PATIENT¿S MEDICAL INFORMATION. A STICKER PAGE LOCATED ON PAGE 12/13, INDICATED THE PATIENT HAD BEEN IMPLANTED WITH ATTUNE COMPONENTS AND COMPETITOR CEMENT IN THE PRIMARY OPERATION. ON (B)(6) 2015, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN AND FLEXION INSTABILITY. THE SURGEON OFFERED NO CONCERNS WITH ANY OF THE IMPLANTED COMPONENTS. THE TIBIAL AND THE FEMORAL COMPONENTS WERE REVISED. THE PATELLAR COMPONENT WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: UNKNOWN. DOR: (B)(6) 2015. (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9291490 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A QUAD TENDON REPAIR 2 YEARS POST JOINT REPLACEMENT. SURGICAL SITE BECAME INFECTED AND SPREAD TO TOTAL JOINT REQUIRING EXTRACTION AND IMPLANTATION OF ANTIBIOTIC SPACER. DOI: (B)(6) 2017 DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9285136 ↗
• InjuryMay 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THE CARDIOPULMONARY ARREST AFTER AN HOUR FROM TKA SURGERY ON (B)(6) 2018. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, AND NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL SUCH AS DISEASE NAME, CAUSAL RELATIONSHIP, OR RECENT PATIENT¿S CONDITIONS.

  Patient problems: Cardiac Arrest; Not Applicable

  MAUDE report 7475351 ↗
• InjuryFeb 7, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AT THE CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7247187 ↗