ATTUNE 1516-40-707Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10603295050223), received between Oct 18, 2017 and Jun 10, 2026 — classified as 47 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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 53 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 25456741 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SWAPPED POLYS FOR A PATIENT THAT FELL AND OPENED UP WOUND. POLY WAS SWAPPED TO ENSURE THERE WOULD BE NO FUTURE INFECTION. THERE WERE NO PATIENT COMPLICATIONS DURING THE PROCEDURE OR PRIOR WITH EXISTING IMPLANTS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 24036082 ↗
• MalfunctionNov 18, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WOULD NOT FULLY SEAT IN THE TIBIAL TRAY. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583007 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23327960 ↗
• 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 22848426 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INFECTION. THE SURGEON CONDUCTED A WASHOUT OF THE KNEE. THE SURGEON EXPLANTED THE 7MM INSERT AND IMPLANTED A NEW 7MM INSERT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21755437 ↗
• InjuryFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER INCISION WAS MADE, THE FB INSERT WAS FOUND NOT TO BE ENGAGED ON THE TIBIAL TRAY. A NEW INSERT WAS IMPLANTED. THIS ISSUE WAS IDENTIFIED VIA POST-OP X-RAY. THE PATIENT WAS NOT EXPERIENCING ANY ADVERSE CONDITIONS FROM THE PRIMARY SURGERY, BUT A POLY SWAP WAS DONE TO ENSURE THE COMPONENT WAS PROPERLY SEATED. NO SURGICAL DELAYS WERE INCURRED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21420754 ↗
• MalfunctionFeb 11, 2025Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? YES 10 MIN OF TRYING TO IMPACT THE POLY IN BUT COULDN¿¿T GET IT. 2. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. USED A DIFFERENT POLY AND IT DIDN¿¿T MATTER 3. PLEASE PROVIDE A VALID LOT NUMBER OF THE REPORTED DEVICE. 4. DID THE EVENT OCCUR DURING PRIMARY OR REVISION SURGERY? PRIMARY. 5. WHAT WAS THE EXACT ALLEGATION AGAINST THE INSERT? THE TABLE ON THE BOTTOM BROKE AND COULDN'T BE LOCKED IN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354439 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY DONE BY THE SURGEON AT THE HOSPITAL ON (B)(6) 2023. THE PATIENT COMPLAINED THAT THE KNEE FELT TIGHT AND THEY HAD LIMITED RANGE OF MOTION. THE SURGEON WAS ABLE TO PULL UP PATIENT RECORDS AND IT SHOWED THEY WERE IMPLANTED WITH A SZ 7, 7MM FB PS INSERT. HE FELT THE PATIENT WOULD BENEFIT FROM GOING DOWN IN POLY THICKNESS. THE 7MM INSERT WAS REMOVED AND A SZ 7, 5MM INSERT WAS TRIALED. THE KNEE WAS LESS STIFF AND THE SURGEON WAS ABLE TO RUN IT THROUGH A MORE1818910-2024-24147 FULL RANGE OF MOTION. THE REAL INSERT WAS OPENED AND IMPLANTED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. THE CLOSING PROCESS BEGAN. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 20756882 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20566441 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF ATTUNE FEMORAL COMPONENT; OSTEOLYSIS OF FEMUR ORIGINAL SURGERY IN (B)(6) OF 2012. LOOSENING REPORTED AT BONE TO CEMENT INTERFACE. DOI: (B)(6) OF 2012. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Osteolysis

  MAUDE report 19730213 ↗
• InjuryApr 29, 2024Adverse 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 INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 19201695 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL AND WAS REVISED TO A LAGER POLY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall

  MAUDE report 18608225 ↗
• MalfunctionSep 27, 2023Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AFFECTED SITE IS THE RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17826016 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH SOME PAIN AND SWELLING. DOCTOR FELT PATIENT HAD INFECTION AND SCHEDULED A POLY SWAP. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17806808 ↗
• MalfunctionSep 18, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY INSERT WOULD NOT SEAT CORRECTLY ON TRAY. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17765521 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AT 3 MONTHS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2) REFERENCE REPORT #MW5119538, #MW5119539, #MW5119540. DOI: OCTOBER 3, 2014. DOR: (B)(6) 2014. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 17557026 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 17058276 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. SURGEON SWAPPED POLY AND DID AN WASH OUT. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17049835 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY, SURGEON UP SIDED POLY. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16896446 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16808418 ↗
• MalfunctionApr 18, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AFTER TAKING OUT AN IMPLANT FROM THE BOX, THE CUSTOMER TRIED TO INSERT AN IMPLANT INTO THE PATIENT'S KNEE. BUT, IT DIDN'T FIX AT ALL SO THAT HE PUT IT OUT AND REPLACE ANOTHER ONE. THERE WAS A SURGICAL DELAY OF TEN MINUTES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16760558 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "DARTMOUTH BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 13.8 MONTHS. REASON FOR REVISION: ARTHROFIBROSIS/INSTABILITY."

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 16378813 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15417955 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. WASHOUT PERFORMED. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15410335 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507