ATTUNE 1504-00-209Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295041245), received between Jan 10, 2018 and Jul 9, 2026 — classified as 14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF AN ATTUNE CRFB CONSTRUCT DUE TO INFECTION. ALL IMPLANTS WERE EXPLANTED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 25767202 ↗
• InjuryNov 17, 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 INSTABILITY AND PATELLA TRACKING ISSUES DUE TO TIBIAL AND FEMORAL ALIGNMENT. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23577667 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION STAGE 1/2. NO DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22895939 ↗
• InjuryJul 15, 2024Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? ALL IMPLANTS REMOVE WHICH TOOK 4 HOURS 2. WHAT IS THE AFFECTED SIDE? RIGHT 3. IT WAS INDICATED THAT THERE WAS LOOSENING. ON WHAT INTERFACE DID THE LOOSENING OCCURRED? TIBIA

  Patient problems: Unspecified Infection

  MAUDE report 19743066 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL, AND KNEE BECAME INFECTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 18608868 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17227413 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT KNEE INFECTION. IMPLANTS REMOVED AND TEMPORARY ABX SPACER WAS IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 15868789 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019: PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OA. THE PATELLA WASN¿T RESURFACED AND CEMENT MFG IS DEPUY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2020: PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN WITH AMBULATION. THERE WERE NO CLINICAL SIGNS OF INFECTION. THE TIBIAL TRAY WAS NOTED TO BE GROSSLY LOOSE AT THE CEMENT TO IMPLANT INTERFACE. LATERAL TIBIAL SUBSIDENCE WAS ALSO NOTED. THERE WERE NO ALLEGED PRODUCT DEFICIENCIES WITH THE FEMORAL COMPONENT OR TIBIAL INSERT. COMPETITOR PRODUCTS WERE PLACED AT REVISION. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12533005 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TKR; ASPIRATION DONE TO CONFIRM INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10397502 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO POSTTRAUMATIC ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR CEMENT. DOI: (B)(6) 2016. DOR: NO REVISION, (RT KNEE).

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9547739 ↗
• MalfunctionDec 18, 2019Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR NOTICEABLE CLACKING MEDIALLY ABOVE THE PATELLA AND PAIN WHOLE KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY/PROBABLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT KNEE).

  Patient problems: Pain

  MAUDE report 9490389 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE TIBIAL INSERT EXCHANGE, IRRIGATION AND DEBRIDEMENT, MANIPULATION, AND PLACEMENT OF ANTIBITOIC BEADS DUE TO CELLULITIS, SUSPECTED POST-OPERATIVE WOUND INFECTION, PATELLA TENDON RUPTURE, FALL, STIFFNESS, DECREASED RANGE OF MOTION, EFFUSION, AND HEMATOMA. THE SURGEON NOTED HE DID NOT REPAIR THE PATELLA TENDON TEAR DUE TO THE FACT THERE IS SUSPICION OF INFECTION AND DID NOT WANT TO HAVE FOREIGN BODIES THAT COULD PERPETUATE FURTHER INFECTION. THE SURGEON OBTAINED INTRA-OPERATIVE CULTURES TO DETERMINE PRESENCE OF WOUND INFECTION. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2018 DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Edema; Hematoma; Limited Mobility Of The Implanted Joint; No Code Available; Unspecified Infection

  MAUDE report 9260724 ↗
• MalfunctionJan 18, 2019Noise, Audible; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE POPS AT NIGHT. EVENT IS RELATED TO DEVICE AND IS NOT RELATED TO PROCEDURE. DOI: (B)(6) 2014. DOE: (B)(6) 2018; (RIGHT KNEE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8260318 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF KNEE JOINT IMPLANTS AND INSERTION OF CEMENT SPACER; ATTUNE IMPLANTS WERE REMOVED DUE TO INFECTION AND NOT BECAUSE THEY HAD FAILED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8161381 ↗
• InjuryOct 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7940231 ↗
• InjuryJan 10, 2018Failure to Align

  DER STATES THAT PATIENT'S KNEE MAY NOT HAVE BEEN PROPERLY ALIGNED DURING HIS PRIMARY KNEE REPLACEMENT PROCEDURE.

  Patient problems: No Information

  MAUDE report 7179785 ↗