ATTUNE 1516-40-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295050230), received between Oct 15, 2018 and Aug 20, 2025 — classified as 27 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (5 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING SIGNS OF INFECTION. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 22849254 ↗
• MalfunctionAug 4, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE SURGICAL PROCEDURE, A DIFFICULTY WAS IDENTIFIED IN THE USE OF THE IMPLANT. THE IMPLANT WAS OPENED, BUT PRESENTED INCOMPATIBILITY AT THE TIME OF IMPLANTATION. BOTH THE DOCTOR AND THE INSTRUMENTALIST FOLLOWED ALL THE TECHNICAL CRITERIA FOR SELECTING THE APPROPRIATE SIZE. DURING THE PROCEDURE, A SLIGHT PROMINENCE WAS OBSERVED IN THE IMPLANT, WHICH COMPROMISED ITS PROPER IMPLANTATION AND GENERATED DIFFICULTIES IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699542 ↗
• InjuryAug 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY RELATED TO THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19884751 ↗
• MalfunctionMay 23, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO THERE WAS NO DELAY IN THE SURGERY. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO THERE WAS NOT.

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

  MAUDE report 19380363 ↗
• MalfunctionMay 20, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DOCTOR WENT TO INSERT THE TIBIAL INSERT AND IT WOULD NOT SEAT. DOE: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19350368 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A POLY SWAP DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19250440 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY AND NEEDED A REVISION. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18711107 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17715328 ↗
• InjuryJun 2, 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 : RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17050264 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED SWAPPED POLY OUT FOR BIGGER SIZE. DOI: (B)(6) 2020; DOR: (B)(6) 2023; AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16984026 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS BILATERAL KNEE INFECTIONS. SWAP THE LEFT AND RIGHT INSERTS. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16853286 ↗
• MalfunctionMay 1, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT AN ATTUNE POLYETHYLENE POSTERIOR STABILIZED INSERT WAS IMPLANTED ON THE (B)(6), WHEN IT WAS OUT OF DATE BY TWO WEEKS..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846260 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 16627286 ↗
• MalfunctionNov 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY INSERT WOULD NOT SEAT. DOE: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827165 ↗
• MalfunctionSep 14, 2022Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON TRIED TO IMPLANT THE POLY INSERT BUT IT WOULD NOT FIT EVEN THOUGH WE TRIALED THROUGH A RANGE OF MOTION WITH THE EXACT SAME SIZE TRIAL INSERT. SO THE SURGEON ASKED FOR ME TO OPEN A NEW ONE SINCE THERE SEEMED TO BE A MALFUNCTION WITH THE ORIGINAL POLY INSERT. THERE WAS A REPORTED SURGICAL DELAY OF ABOUT 10 MINUTES. DOE: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417350 ↗
• MalfunctionApr 11, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE BOX OF THE IMPLANT WAS OPENED AND THERE WAS NO POLY INSERT INSIDE THE BOX. THE BOX WAS EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074387 ↗
• InjuryOct 6, 2021Adverse 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) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12584018 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT SIDE.

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

  MAUDE report 12526137 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 3 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS TIBIAL TRAY AND FEMORAL COMPONENT LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED SCAR TISSUE, TIBIAL AND FEMORAL BONE LOSS, AND SIGNIFICANT REACTIVE SYNOVIUM WITH FRONDULAR TYPE FRIABLE TISSUE. ALL COMPONENTS WERE REVISED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12234669 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 30 OCT 2020 WAS REVIEWED. ON (B)(6) 2015, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. DEPUY COMPONENTS, INCLUDING PATELLA WERE IMPLANTED. COMPETITOR CEMENT WAS USED. THERE WERE NO COMPLICATIONS NOTED IN THE OPERATIVE NOTES. ON (B)(6) 2019, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS ASEPTIC LOOSENING OF TIBIAL COMPONENT AT THE IMPLANT/CEMENT INTERFACE, PAIN, AND OSTEOLYSIS AROUND THE FEMORAL COMPONENT. THERE WAS NO MENTION OF REVISING THE PATELLA. COMPETITOR COMPONENTS INCLUDING COMPETITOR CEMENT WERE UTILIZED IN THIS PROCEDURE. DOI: (B)(6) 2015 ; DOR: (B)(6) 2019 (RIGHT KNEE).

  Patient problems: Osteolysis; Pain

  MAUDE report 10949990 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TO TREAT PAIN AND SWELLING SECONDARY TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE I & D WITH INSERT REVISION TO TREAT WOUND DRAINAGE SECONDARY TO STAPH EPIDERMIDIS. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED CHRONIC INFLAMMATION. SYNOVITIS AND SCAR TISSUE WERE EXCISED. A THOROUGH DEBRIDEMENT WAS PERFORMED, AND THE INSERT WAS EXCHANGED. COMPETITOR ANTIBIOTIC PELLETS WERE PLACED. THE PATIENT WAS REVISED WITH A DEPUY INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT RECEIVED 6 WEEKS OF IV ANTIBIOTIC TREATMENT. DOI: (B)(6) 2016, DOR: (B)(6) 2016 (INSERT), RIGHT KNEE.

  Patient problems: Adhesion(s); Inflammation; No Code Available; Synovitis; Unspecified Infection

  MAUDE report 10621862 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT PAIN SECONDARY TO SEVERE DEGENERATIVE VARUS OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. CLAIM SHEET INDICATES THAT PATIENT RECEIVED A LEFT KNEE REVISION. REVISION OPERATIVE NOTES WERE NOT PROVIDED. DOI: (B)(6) 2016, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10315824 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A BILATERAL PRIMARY ATTUNE SYSTEM TO TREAT END-STAGE SEVERE ARTHRITIS WITH DEFORMITY. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED ON EACH KNEE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT REVISION TO TREAT ASEPTIC LOOSENING. UPON ENTERING THE KNEE, THE SURGEON ENCOUNTERED AND EXCISED SYNOVITIS. THE TIBIAL TRAY AND FEMORAL COMPONENTS WERE GROSSLY LOOSE AT AN UNKNOWN INTERFACE AND REVISED. THE SURGEON DISCOVERED SEVERE OSTEOLYSIS ON THE FEMORAL CONDYLE. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9979063 ↗
• MalfunctionMar 12, 2020Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT'S PRIMARY ATTUNE FIXED BEARING TIBIAL TRAY AND FIXED BEARING POSTERIOR STABILIZED INSERT WERE REMOVED AND REPLACED BY AN ATTUNE REVISION ROTATING PLATFORM TIBIAL TRAY WITH A FULLY COATED SLEEVE AND A CEMENTED STEM, AND AN ROTATING PLATFORM POSTERIOR STABILIZED INSERT. THE SURGEON, BELIEVES THAT THE DESIGN OF THE UNDERSIDE OF THE PRIMARY TIBIAL TRAY MAY HAVE BEEN DEFICIENT, SINCE THERE WAS NOT A TRACE OF BONE CEMENT ATTACHED TO THE UNDERSIDE OF THE PRIMARY TIBIAL TRAY UPON ITS REMOVAL. DEPUY SMARTSET MEDIUM VISCOSITY BONE CEMENT WAS UTILIZED IN THE PRIMARY SURGERY; HOWEVER, THE PRODUCT CODES AND LOT NUMBERS FOR THE TWO BAGS OF CEMENT USED ARE NOT AVAILABLE. DOI: (B)(6) 2016. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9825616 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 9565203 ↗

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