ATTUNE 1516-40-507Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10603295049944), received between Aug 18, 2017 and Jun 25, 2026 — classified as 74 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 15, 2023Open, Classified

   The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

   Z-1267-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT OSTEOPHYTE FORMATION LIMITING ROM. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: (B)(6) 2026.

  Patient problems: Bone Notching; Loss of Range of Motion

  MAUDE report 25627030 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME IN TODAY WITH AN UNSTABLE KNEE. DOCTOR SUSPECTED A LOOSE TIBIA. UPON CHECKING ALL COMPONENTS WERE WELL FIXED AND HE REGAINED STABILITY WITH A THICKER FPBS POLY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25331603 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND INSTABILITY IN THE RIGHT KNEE. BOTH THE LATERAL COLLATERAL LIGAMENT (LCL) AND MEDIAL COLLATERAL LIGAMENT (MCL) HAD BEEN SURGICALLY REPAIRED PREVIOUSLY. DOI (B)(6) 2023. DOR(B)(6) 2026 AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24532641 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S KNEE WAS REVISED DUE TO INFECTION. DURING THE FIRST STAGE OF WHAT WILL BE A TWO STAGE REVISION PROCEDURE, THE PATIENT'S PRIMARY ATTUNE COMPONENTS WERE REMOVED AND REPLACED BY AN ANTIOBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 24302160 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNSTABLE. SURGEON WENT TO A 5-12. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23703990 ↗
• InjuryNov 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE KNEE WAS REVISED DUE TO POLY LINER LOCKING MECHANISM WAS DISASSOCIATING FROM TIBIAL BASE PLATE. NO OTHER INFORMATION IS KNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23658641 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH POLY EXCHANGE DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 23643317 ↗
• InjuryNov 21, 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 PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23624174 ↗
• InjuryNov 4, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO PAIN. TIBIAL INSERT SHOWED MODERATE YELLOWING.

  Patient problems: Pain

  MAUDE report 23465941 ↗
• MalfunctionSep 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WOULD NOT SEAT ON THE TIBIAL BASE. PATIENT WAS NOT AFFECTED AND NEW IMPLANT WAS OPENED. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025402 ↗
• MalfunctionAug 18, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA). TIBIA INSERT DID NOT ENGAGE INTO TIBIA TRAY. DOI: UNKNOWN. DOR: (B)(6), 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22833132 ↗
• InjuryJul 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 PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 22532419 ↗
• InjuryJul 14, 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 UNSTABLE KNEE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22494250 ↗
• InjuryApr 2, 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 PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024 , DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21757331 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT KNEE WAS TOO TIGHT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 21172638 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND THE SURGEON DID A WASHOUT WITH POLY EXCHANGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21078345 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED AND POLY SWAPPED DUE TO FALLING. THERE WAS NO LOOSENING. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 19380997 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 19221336 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE LOOSENING INTERFACE WAS TIBIA FROM CEMENT. THE CEMENT USED IS ALSO UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18606751 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS CONCERN ABOUT ATTUNE DEPUY KNEE REPLACEMENT. THE PATIENT HAS BEEN EXPERIENCING PAIN, SWELLING, EFFUSION, AND THE FEELING LIKE HER KNEE IS GIVING OUT. THE PATIENT IS MEETING WITH A SURGEON TO DISCUSS POTENTIAL REVISION. DOI: (B)(6) 2018. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 18541756 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D). POLY WAS SWAPPED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17649866 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH GLOBAL INSTABILITY OF HER KNEE REPLACEMENT POST COVID. SHE HAD AN ABOVE AVERAGE RECOVERY FROM HER TKA AND WAS VERY HAPPY PRIOR TO HER ILLNESS. A POLY EXCHANGE WAS PERFORMED GOING FROM A 7MM TO A 10MM INSERT. JOINT IS WELL ALIGNED, APPROPRIATELY SIZED, JOINT LINE NOT CHANGED ETC. NO POLY WEAR WAS NOTED. NO INSTRUMENTS WERE BROKEN. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16921006 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHESE ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 51.7 MONTHS. REASON FOR REVISION: LOOSE, LYSIS, SUBSIDENCE.

  Patient problems: Osteolysis

  MAUDE report 16352225 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNEVENTFUL RECOVERY FROM TOTAL KNEE BUT SHOWS UP IN EMERGENCY ROOM THIS WEEK WITH SWOLLEN DRAINING KNEE AND DIAGNOSIS OF AN UNTREATED PERSISTENT UTI. DUE TO DRAINING, SURGEON CHOOSES TO PERFORM AN I&D OF KNEE, POLY EXCHANGE AND PLACEMENT OF ANTIBIOTIC ABSORBABLE BEADS. FROZEN SECTION FROM PATHOLOGY IS INCONSISTENT WITH INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 16101904 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL IN HOSPITAL AND TORE INCISION OPEN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 15983778 ↗