ATTUNE 1516-50-808Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295052876), received between Aug 10, 2017 and Aug 26, 2026 — classified as 39 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised with second liner exchange to rule out infection. Affected side: Left

  Patient problems: Unspecified Infection

  MAUDE report 50454096 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON PERFORMED INS LINER EXCHANGE TO PREVENT INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25348456 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED BECAUSE OF A PATELLA FRACTURE/FRAGMENT. DURING THE EXCISION OF THE FRAGMENT, THE DOCTOR CHOSE TO SWAP THE POLY TO THE SAME SIZE AND THICKNESS. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 24639709 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSE UNSTABLE KNEE. POLY WAS REMOVED AND NEW 14MM POLY WAS TRIALED. SURGEON LIKED THE STABILITY AND IMPLANTED THE ATTUNE SIZE 8 14MM RP PS POLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23636643 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED FOR LAXITY. SURGEON INCREASED THICKNESS FROM 8 TO 10MM. ORIGINAL DATE OF SURGERY COULD NOT BE CONFIRMED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23609339 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH REPEAT WASHOUT AND INSERT EXCHANGE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23303769 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH CHRONIC EFFUSIONS. NO COMPONENTS WERE FOUND TO BE LOOSE. THE POLY MAY HAVE BEEN IMPINGING ON BONE CEMENT IN THE NOTCH. SURGEON DEBRIDED THE JOINT SPACE AND REPLACED THE POLY. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Swelling/ Edema

  MAUDE report 21755528 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO DRAIN AFTER AN I&D AND POLY EXCHANGE THAT WAS PERFORMED ONE WEEK AND TWO DAYS PRIOR. SURGEON CHOSE TO BRING HIM BACK TO THE OR FOR AN ADDITIONAL WASHOUT AND COMPONENT EXCHANGE. AFTER EXTENSIVE DEBRIDEMENT AND IRRIGATION, SURGEON CHOSE TO EXCHANGE MORE COMPONENTS THAN JUST HE INSERT. SURGEON CHOSE TO EXCHANGE HIS FEMORAL COMPONENT AND AUGMENT. THIS ALLOWED FOR MORE SPACE IN BOTH FLEXION AND EXTENSION AS HIS ROM WAS LIMITED. HE ALSO EXCHANGED HIS PATELLAR COMPONENT. THE PATELLAR COMPONENT WAS FOUND TO BE LOOSE UPON EXAMINATION. CEMENT WAS LIKELY DEPUY 2 WITH GENT. THERE WAS PATELLAR COMPONENT LOOSENING AT BONE/CEMENT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Loss of Range of Motion

  MAUDE report 21137761 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. WAS THERE ANY SPECIFIC ALLEGATION AGAINST THE REPORTED PRODUCT? NO.

  Patient problems: Pain

  MAUDE report 20311566 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFLAMMATION, THE KNEE WAS WASHED OUT AND POLY COMPONENT REPLACED. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inflammation

  MAUDE report 19510886 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: UNK. DATE OF REVISION #1: (B)(6) 2023. DATE OF REVISION #2: (B)(6) 2024. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL BASE, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19229596 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO KNEE IRRIGATION AND DEBRIDEMENT (I&D). DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19119017 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI- UNKNOWN, DOR- (B)(6) 2023, AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17610471 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. ANTIBIOTIC SPACER WAS IMPLANTED. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16276823 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15526023 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS A COMPETITOR. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 15347437 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FEELINGS OF STIFFNESS, ADHESIONS, PAIN, AND DECREASED ROM EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2022. TREATMENT: MAU, INSERT REVISION. DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 150680001 LOT ID: 8954195 COMPONENT TYPE: TIBIAL DESCRIPTION: ATTUNE ROTATING PLATFORM TIBIAL BASE SIZE 1 CEMENTED CATALOG ID: 151820041 LOT ID: 9257559 COMPONENT TYPE: PATELLAR DESCRIPTION: ATTUNE MEDIAL DOME PAT 41MM CATALOG ID: 150410201 LOT ID: 9259336 COMPONENT TYPE: FEMORAL DESCRIPTION: ATTUNE POST/STAB FEM RT SZ 1 CEMENTED CATALOG ID: 151650808 LOT ID: 8806004 COMPONENT TYPE: INSERT DESCRIPTION: ATTUNE PS/RP INSERT SZ 8 8MM.

  Patient problems: Adhesion(s); Muscular Rigidity; Pain

  MAUDE report 14653486 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PAINFUL RIGHT KNEE. DOI- (B)(6) 2022. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13761368 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2013 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO OSTEOLYSIS, EFFUSION AND PAIN. UPON ENTERING THE JOINT, THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE. THE FEMORAL, TIBIAL AND INSERT COMPONENTS REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 12703843 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. IT CAME OUT WITH 2 LIGHT TAPS ON THE EDGE OF THE TIBIAL TRAY. THE BROKEN WAS BETWEEN THE TRAY AND THE CEMENT, NOT THE BONE AND CEMENT. REVISED ALL COMPONENTS TO GET A BETTER BALANCE OF THE KNEE. DOI: (B)(6) 2014, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12527485 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT AND POLY SWAP. NO IMPLANT FAILURE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNKNOWN KNEE.

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

  MAUDE report 12474506 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 12466883 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON DID AN I&D/POLY SWAP. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 12384133 ↗
• MalfunctionJul 1, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE POLY WAS FRAYING WHERE SIZES WERE MILLED. A NEW POLY WAS REQUESTED. DOE: (B)(6) 2021. LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099955 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STAGE 1 REVISION OF RIGHT ATTUNE TOTAL KNEE TO TREAT PAIN, FEVER, AND SWELLING SECONDARY TO INFECTION. SURGERY PERFORMED TO REMOVE IMPLANTS, DEBRIDEMENT AND INSERTION OF CEMENT SPACERS. DOI: (B)(6) 2019. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fever; Pain; Swelling/ Edema

  MAUDE report 11712189 ↗