ATTUNE 1516-20-805Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10603295046004), received between Sep 28, 2017 and Aug 6, 2026 — classified as 45 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50163954 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLY SWAP WAS PERFORMED DUE TO INFECTION. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25334734 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE POLY SWAP DUE TO INSTABILITY. THE PREVIOUS SURGEON LEFT THE KNEE TOO LOOSE, RESULTING IN PAIN AND THE NEED FOR REVISION SURGERY. THERE WAS NO POLYETHYLENE WEAR, NO MALPOSITIONING OR NO UNDERSIZING REPORTED EXCEPT THAT THE POLYETHYLENE THICKNESS WAS TOO THIN FOR CORRECT TENSIONING OF THE JOINT. DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24714681 ↗
• InjuryOct 27, 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: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23393533 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH GROSS INFECTION WITH A DRAINING SINUS POST TKA. ALL COMPONENTS WERE REMOVED AND A THOROUGH I&D WAS PERFORMED AND A STATIC SPACER FASHIONED UTILIZING LPS COMPONENTS COATED WITH HIGH DOSE ANTIBIOTIC CEMENT. RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN THE FEMORAL AND TIBIAL CANALS ALONG WITH THE GUTTERS. THERE WAS NO DELAY NOR WAS ANY PATENT HARM NOTED. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23301059 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: THE ALLEGATION WAS THE PATELLA AND POLY. THESE WERE THE ITEMS THAT GOT SWAPPED OUT. THE TIBIA AND FEMUR STAYED IN THE PATIENT YOU CAN REMOVE THE FEMUR AND TIBIA FROM THE PRODUCT COMPLAINT.

  Patient problems: Pain

  MAUDE report 22914176 ↗
• MalfunctionDec 3, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE IMPLANT WAS CHIPPED. IT DID NOT HAPPEN IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836152 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LEFT KNEE REVISION OCCURRED (B)(6) 2024 DUE TO THE KNEE BEING UNSTABLE SO NEEDED A POLY SWAP. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DATE OF IMPLANT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20407327 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  PATIENT HAD A KNEE DONE ALMOST 10 YEARS AGO. AND WAS NEVER VERY HAPPY WITH IT. IT WAS LOOSE IN FLEXION AND EXTENSION. SURGEON REMOVED THE OLD LINER THAT HAD SOME WEAR POSTERIORLY AND REPLACED IT WITH A 3MM THICKER MS POLY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 20032966 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF PAIN AND SURGEON NOTES GLOBAL INSTABILITY. ALL COMPONENTS ARE REMOVED AND A KNEE REVISION IS PERFORMED. NO DELAY OR PATIENT HARM IS NOTED. COMPONENTS ARE WELL FIXED, APPROPRIATELY SIZED IN GOOD ALIGNMENT AND JOINT LINE APPEARS APPROPRIATE. NO WEAR IS NOTED. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Joint Laxity; Pain

  MAUDE report 19361365 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6); STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR EFFUSION IN RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2013, DATE OF EVENT: (B)(6) 2014, (RIGHT KNEE). TREATMENT: CULTURE TAKEN.

  Patient problems: Swelling/ Edema

  MAUDE report 19215295 ↗
• MalfunctionApr 8, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE WHEN INSERTED THE DEFINITIVE IMPLANT ¿APPEARED¿ SEATED BUT WAS IDENTIFIED LOOSE WHEN MANIPULATING THE KNEE. THE IMPLANT WAS REMOVED AND CHECKED FOR SOFT TISSUE ENTRAPMENT AND REINSERTED, BUT WITH THE SAME ISSUE OUTCOME. DUE TO THIS THE IMPLANT WAS REMOVED AND ASKED FOR ANOTHER FRESH INSERT. THIS WAS OPENED AND IMPLANTED WITHOUT ISSUE. NO HARM TO PATIENT OCCURRED AS A RESULT OF THIS ISSUE, HOWEVER THERE WAS SOME DELAY TO SURGERY AS A RESULT OF HAVING TO RETRIEVE A SECOND IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057996 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 18449045 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17735892 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S KNEE WAS "WOBBLY". UPON PHYSICAL EXAM SURGEON NOTED MILD LAXITY. A THICKER POLY WAS PLACED UNEVENTFULLY. NO PATIENT HARM WAS OCCURRED. KNEE WAS WELL ALIGNED, APPROPRIATELY SIZED, JOINT LINE WAS NOT RAISED AND POSTERIOR OFFSET WAS MAINTAINED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17607816 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT 'S BILATERAL KNEES WERE DONE. FIRST CASE WAS DONE BACK IN (B)(6) 2022. SECOND CASE WAS (B)(6) 2022: PATIENT HAD ACUTE PERIPROSTHETIC JOINT INFECTION. MS INSERTS REPLACED BOTH. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16947783 ↗
• 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 0.5 MONTHS. REASON FOR REVISION: INFECTION."

  Patient problems: Unspecified Infection

  MAUDE report 16378804 ↗
• 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 1.1 MONTHS. REASON FOR REVISION: INFECTION, PAIN."

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16378689 ↗
• 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 28.4 MONTHS. REASON FOR REVISION: INSTABILITY, PAIN"

  Patient problems: Joint Laxity; Pain

  MAUDE report 16378489 ↗
• InjuryFeb 2, 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 SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 1.7 MONTHS. REASON FOR REVISION: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16282843 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13976381 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 07 DEC 2021 REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, INSTABILITY, AND ASEPTIC LOOSENING. UPON ENTERING THE JOINT, SCARRING WAS NOTED TO BE RESECTED. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE ¿ INTERFACE NOT PROVIDED. THE TIBIAL COMPONENT WAS ALSO NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. ALL COMPONENTS REVISED AND REPLACED WITH COMPETITOR PRODUCT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2019; DOR: (B)(6) 2021: (RIGHT KNEE).

  Patient problems: Joint Laxity; Pain; Scar Tissue

  MAUDE report 13175509 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POLY EXCHANGE DUE TO INSTABILITY. DOI : (B)(6) 2020, DOR : (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12846774 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN. ALL COMPONENTS WERE WELL-FIXED. UNKNOWN ORIGINAL SURGERY DATE/LOCATION. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12681102 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. REMOVED FEMUR, TIBIA AND INSERT. ANTIBIOTIC SPACER PUT IN. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 12358840 ↗