ATTUNE 1504-11-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295041924), received between Dec 19, 2019 and May 12, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPLANT FOR SUSPECTED INFECTION 4TH OPERATION ON THIS KNEE NO WAY TO CONFIRM INFECTION. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25150655 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED TO TREAT INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22848439 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A LEFT TOTAL ATTUNE KNEE THAT IS INFECTED. THE KNEE WAS IMPLANTED ON (B)(6) 2022 AND HAD AN INSERT EXCHANGE WASHOUT ON (B)(6) 2022. THE KNEE IS STILL INFECTED, SO THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED TEMPORARY IMPLANTS. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE. THE FIRST REVISION SURGERY INVOLVING THE INSERT EXCHANGE AND WASHOUT WAS CAPTURED IN (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19021040 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17686985 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON BEHALF OF THE PATIENT: PATIENT SAID THAT HE HAD 2 SURGERIES THAT RESULTED IN KNEE REPLACEMENT INTO HIS LEGS. THE FIRST SURGERY HAPPENED IN 2021 HE SAID THAT WAS PERFECTLY FINE. SECOND SURGERY HAPPENED 3 MONTHS BACK HE FEEL PAIN. HE THINK THAT THE DOCTOR PUT IN INCORRECTLY WHICH IS SOMETHING WRONG WITH THE ITEM. IT WAS THE SAME DOCTOR THAT DID BOTH THE PROCEDURES. PATIENT SAID HE NO LONGER CAN WORK AND ALSO WALK, WALKS WITH THE CANE AND ALSO LOST HIS JOB.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 17001724 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RÉVISION KNEE. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN, 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? WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, (B)(4) DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE, (B)(4) DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE, (B)(4) DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE, (B)(4) 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: Pain

  MAUDE report 15329329 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A LEFT KNEE MANIPULATION TO ADDRESS ARTHROFIBROSIS, DECREASED ROM ISSUES, PAIN, WITH MODERATE SWELLING. DOI: (B)(6) 2020. DOE: (B)(6) 2020.

  Patient problems: Fibrosis; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14286927 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE TIBIAL COMPONENT AT THE IMPLANT TO BONE INTERFACE. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12453200 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PRESENCE OF INFECTION. REMOVAL OF TOTAL KNEE CONSTRUCT AND PLACEMENT OF ANTIBIOTIC SPACER WAS DONE. DOI: (B)(6) 2021. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12000389 ↗
• InjuryJul 28, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT TKA IN FEBRUARY. PATIENT PRESENTED WITH AN INFECTED TOTAL KNEE. SURGEON WAS PLANNING ON A I AND D OF THE KNEE WITH INSERT EXCHANGE. UPON OPENING THE KNEE, IT WAS DISCOVERED BOTH THE TIBIAL COMPONENT AND FEMORAL COMPONENT WERE LOOSE. SURGEON REMOVED ALL COMPONENTS AND DID A INFECTED KNEE SPACER FROM EXACTECH. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10335943 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FLEXION CONTRACTURE AND INSUFFICIENT RANGE OF MOTION IN LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD . EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: PHYSICAL THERAPY. PRODUCT DETAILS: COMPONENT TYPE: ATTUNE PS FEM LT SZ 7 POR . CATALOG NUMBER: 150411107. PRODUCT ID/LOT NUMBER: 8904755. COMPONENT TYPE: ATTUNE RP TIB BASE SZ 8 POR. CATALOG NUMBER: 150611008. PRODUCT ID/LOT NUMBER: 8748727. COMPONENT TYPE: ATTUNE PS/RP INSERT SZ 7 7MM. CATALOG NUMBER: 151650707. PRODUCT ID/LOT NUMBER: 9436849.

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

  MAUDE report 10220823 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS OF LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2019, DOE: (B)(6) 2019, (LEFT KNEE).

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10197532 ↗
• InjuryJun 11, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS SUSPECTED INFECTION AND LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENTS AT THE BONE TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED FOR THE EXPLANTED CEMENTED IMPLANT. COMPONENTS WERE EXPLANTED AND ABX LOADED SPACER WAS INSERTED. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10144653 ↗
• InjuryJun 10, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS SUSPECTED INFECTION AND LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENTS AT THE BONE TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED FOR THE CEMENTED IMPLANT REMOVED. COMPONENTS WERE EXPLANTED AND INSERTED ABX LOADED SPACER. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10137916 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019 (LEFT KNEE).

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9596192 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019. (LEFT KNEE). TREATMENT INCLUDES: HOSPITAL RE-ADMISSION, ANTICOAGULANT MEDICATION, CT ANGIOGRAPHY. EVENT IS CONSIDERED RECOVERED/RESOLVED AS OF (B)(6) 2019.

  Patient problems: Hematoma; Pain; Pulmonary Embolism

  MAUDE report 9494928 ↗