ATTUNE 1516-40-506Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10603295049937), received between Jan 31, 2018 and Jul 29, 2026 — classified as 108 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient hyperextends.Affected side-Left knee.

  Patient problems: Joint Laxity

  MAUDE report 50068375 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTY, CONSISTING OF A RIGHT TOTAL KNEE ARTHROPLASTY ON MARCH 6 FOR RIGHT KNEE OSTEOARTHRITIS AND A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) FOR LEFT KNEE OSTEOARTHRITIS. ON (B)(6) 2025, THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY DUE TO A LOOSE TIBIAL COMPONENT, OSTEOLYSIS INVOLVING THE LATERAL FEMORAL CONDYLE AND LATERAL TIBIAL PLATEAU, AND INSTABILITY WITH LOOSENESS IN EXTENSION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 25458755 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT RECEIVED A LEFT ATTUNE TKA TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PRIMARY PART/LOT INFORMATION IS AVAILABLE ON PP. 1. ON (B)(6) 2022 THE PATIENT RECEIVED A LEFT KNEE ATTUNE TKA TO TREAT PAIN AND A SUBSIDED TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED SCAR TISSUE, SYNOVITIS, AND EDEMA. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT WAS LOOSENED AT THE CEMENT TO IMPLANT AND CEMENT TO BONE INTERFACE AND REVISED. THERE WAS EXTENSIVE FEMORAL OSTEOLYSIS AND INFLAMMATION. THE TIBIAL TRAY WAS LOOSENED AT AN UNKNOWN INTERFACE AND HAD MIGRATED AND WAS REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED AN ATTUNE REVISION CONSTRUCT WITH UNKNOWN CEMENT. DURING THE REVISION, THE FEMORAL AUGMENT DID NOT SEAT ON THE FEMORAL COMPONENT PROPERLY, WHICH CAUSED A FEMORAL CRACK WHEN THE SURGEON ATTEMPTED TO IMPLANT THE FEMORAL COMPONENT. THE AUGMENT WAS REPOSITIONED AND THE NEW FEMORAL COMPONENT SEATED APPROPRIATELY. THE CRACK WAS TREATED WITH A CERCLAGE CA

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Discomfort; Inflammation; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 24818271 ↗
• MalfunctionApr 8, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ANTERIOR FLAP OF THE INSERT DOES NOT FIT PROPERLY, LEAVING THE INSERT FORWARD. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816226 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24675882 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23770981 ↗
• MalfunctionJun 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE TOTAL KNEE REPLACEMENT SURGERY, IT WAS FOUND THAT THE DEVICE IS TOO THICK AND CANNOT BE NORMALLY IMPLANTED INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236091 ↗
• MalfunctionDec 6, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO B. WERE THERE ANY ADVERSE CONSEQUENCE/S TO THE PATIENT RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE THE DETAILS. NO. C. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE DETAILS. *ON FUTURE REPORTS: IF THE PATIENT WAS NOT AFFECTED BY INSTRUMENTATION THAT WAS BROKEN INTO MORE THAN ONE PIECE, PLEASE MARK THIS QUESTION N/A, NOT APPLICABLE. NO.

  Patient problems: Insufficient Information

  MAUDE report 20868432 ↗
• InjuryDec 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A TKA WITH THE INSERT FOR KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2024, THE SURGEON INFORMED THAT THE INSERT MIGHT HAVE BEEN DISLOCATED. THE PATIENT TWISTED THE KNEE WHILE TRYING TO STAND UP FROM A SQUATTING POSITION. ON (B)(6) 2024, THE INSERT WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 20864636 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LCL WAS TORN AND NOT REPAIRABLE. SURGEON REMOVED COMPONENTS AND CONVERTED TO SROM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2024 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20678846 ↗
• MalfunctionOct 24, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED ON (B)(6) 2024 THAT THE DEVICE COULD NOT BE IMPLANTED IN PLACE. IT WAS REPORTED THAT DURING THE SURGERY, THE IMPLANT COULD NOT IMPLANTED INTO THE TIBIAL PLATEAU. SURGERY TIME WAS EXTENDED 15 MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522322 ↗
• MalfunctionOct 14, 2024Difficult to Insert; Difficult to Insert

  THE INSERT WAS NOT LOCKED TO TIBIA. PROPER IMPACTING WAS CONDUCTED, BUT IT DETACHED FROM TIBIA CONTINUOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438662 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 19742193 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO THICKER POLY FOR INSTABILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19340480 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2017 THE PATIENT HAD BILATERAL KNEE ARTHROPLASTIES TO ADDRESS SEVERE PRIMARY OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THESE PROCEDURE, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 (LEFT KNEE STICKER SHEET PAGE 7 OF 16)(RIGHT KNEE STICKER SHEET PAGE 16 OF 16). ON (B)(6) 2023, THE PATIENT HAD A LEFT KNEE REVISION TO ADDRESS THE MECHANICAL FAILURE OF THE PROSTHETIC LEFT KNEE JOINT. DURING THE PROCEDURE, THE SURGEON NOTED THERE WAS A LARGE AMOUNT OF SCAR TISSUE, THERE WAS EXTENSIVE THICKNESS OF THE PATELLA AND IT WAS REMOVED. THERE WAS EVIDENCE OF LOOSENING OF THE TIBIAL TRAY COMPONENT WITH SEPARATION OF THE TIBIAL TRAY FROM THE CEMENT MANTLE. ALL COMPONENTS WERE REMOVED AND COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2017; DOR: (B)(6) 2023; LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 19277486 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR LOOSE TIBIA. EXPLANT THE ATTUNE TIBIAL TRAY AND STABILIZE INSERT. DOI: (B)(6) 2016. DOE: (B)(6) 2024. AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 19034498 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2024. (RIGHT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 19032459 ↗
• InjuryJan 31, 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 HARM TO THE PATIENT AND NO SURGICAL DELAY WAS REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 18615312 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGEON WENT UP TO AN 8MM POLY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE : UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18467609 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED BILATERAL INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: MAY 8,2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17885921 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. FEMORAL COMPONENT WAS NOT REVISED. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17780269 ↗
• MalfunctionApr 21, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE IMPLANTING THE POLY INSERT, SURGEON WAS UNABLE TO SEAT THE POLY.

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

  MAUDE report 16792466 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. I&D AND POLY EXCHANGE WERE PERFORMED. DOI- (B)(6) 2023, DOR- (B)(6) 2023, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16783776 ↗
• InjuryApr 5, 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: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16682993 ↗
• MalfunctionFeb 16, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE ATTUNE FIXED BEARING INSERT SIZE 5/6 MM WOULD NOT LOCK INTO THE TIBIAL TRAY. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390209 ↗

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