ATTUNE 1516-40-305Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295049647), received between Jun 22, 2017 and Mar 6, 2026 — classified as 18 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BILATERAL KNEE PAIN, PARTICULARLY IN THE RIGHT KNEE, FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PAIN WAS CONSIDERED TO BE DUE TO PROSTHESIS DISCOMFORT OR EXCESSIVE SUTURE TENSION AFTER JOINT REPLACEMENT. THE STITCHES WERE INTERMITTENTLY REMOVED FROM THE WOUND FOR DRESSING CHANGE TO REDUCE THE WOUND TENSION. THE PATIENT WAS GIVEN IODOPHOR SOLUTION FOR DRESSING CHANGE. PATIENT IMPROVED SIGNIFICANTLY AFTER A FEW DAYS AND WAS DISCHARGED. PRODUCT NOT EXPLANTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Discomfort; Pain

  MAUDE report 24533343 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNSTABLE AND HAD A PAINFUL KNEE. TIBIAL TRAY WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2017, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22676845 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16857760 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND USED A THICKER POLY. DOI- FEBRUARY 12, 2016. DOR- APRIL 10, 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16815802 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(6) 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 2.1 MONTHS. REASON FOR REVISION: FAILED TKA, ARTHROCUTANEOUS FISTULA, PERIPROSTHETIC JOINT INFECTION, FAILURE OF EXTENSOR MECHANISM".

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16364149 ↗
• MalfunctionAug 19, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE INSERT FOR THE RHEUMATOID ARTHRITIS. DURING THE SURGERY, LOCKING FAILURE OF THE INSERT OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258752 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION RIGHT TOTAL KNEE ARTHROPLASTY.

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

  MAUDE report 12542130 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A BILATERAL TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED BILATERALLY, AND COMPETITOR CEMENT WAS UTILIZED X2 BILATERALLY FOR A TOTAL QUANTITY OF 4. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, FAILED RIGHT KNEE REPLACEMENT WITH GROSS LOOSENING AND VARUS COLLAPSE OF THE TIBIA, OSTEOLYSIS AND MALALIGNMENT OF THE FEMORAL AND PATELLA COMPONENTS. UPON ENTERING THE JOINT, PARAPATELLAR ADHESIONS WERE RELEASED AND SYNOVECTOMY WAS PERFORMED. THE TIBIAL COMPONENT WAS EASILY REMOVED, LOOSENING NOTED AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR IMPLANTS WERE UTILIZED AT THIS REVISION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016 DOR: (B)(6) 2020 RIGHT KNEE

  Patient problems: Adhesion(s); No Code Available; Osteolysis; Pain

  MAUDE report 10454782 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC NOTE DATED 12 DEC 2019: PATIENT PRESENTS WITH PERSISTENT PAIN AND INSTABILITY. PHYSICAL EXAM CONFIRMS THE INSTABILITY. X-RAYS INDICATE POSSIBLE LOOSENING OF THE TIBIAL TRAY. THE PHYSICIAN NOTES THE LOOSENING OF THE TRAY WAS NOT CONFIRMED. PATIENT IS REFERRED FOR REVISION SURGERY.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 10235736 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR LEFT KNEE REVISION TO ADDRESS ARTHROFIBROSIS DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE). FEMUR AND TIBIAL INSERT COMPONENTS REVISED.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9553943 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS LOOSENESS IN FLEXION AND EXTENSION. DOI: (B)(6) 2013. DOR: (B)(6) 2014, (LEFT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9544708 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS FLEXION CONTRACTURE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9520678 ↗
• MalfunctionNov 26, 2019Difficult to Insert; Fitting Problem; Difficult to Insert; Fitting Problem

  WILL NOT LOCK. IT WAS REPORTED THAT DURING THE TOTAL KNEE REPLACEMENT OPERATION, THE CENTRAL PART COULD NOT LOCK. INSERT INTO PLATFORM THEN IT POPPED OUT AUTOMATICALLY. TRIED MANY TIMES, BUT STILL FAILED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376588 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: MEDICAL RECORDS RECEIVED ON AD 27 FEB 2020 WERE REVIEWED ON AD 12 MARCH 2020. PRIMARY OPERATIVE NOTES INDICATE THE PATIENT RECEIVED A PRIMARY ATTUNE TKA TO TREAT SEVERE OSTEOARTHRITIS OF THE RIGHT KNEE. INTRAOPERATIVELY, THE SURGEON NOTED SEVERE DEGENERATIVE CHANGES OF THE NATURAL JOINT AND EFFUSION. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: No Code Available; Pain

  MAUDE report 9347548 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 1. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO STIFFNESS, INSTABILITY, AND PAIN. THE SURGEON REVISED THE TIBIAL COMPONENT. HE NOTED A WELL-FIXED FEMORAL COMPONENT AND IT WAS NOT REVISED. THE SURGEON INDICATED THE PATELLA TRACKED APPROPRIATELY AND WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016; DOR: (B)(6) 2018; (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9317047 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, STIFFNESS, ARTHROFIBROSIS, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9312294 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY- RT 3N PS FEMUR - REF. 150410223, LOT: 460021; SZ 3 TIBIAL TRAY - REF. D150600003, LOT: 8175579; SZ 3 PS 5MM POLY INSERT - REF. 151640305; LOT: 462941; CEMENT USED: CMW 2 - REF. 3325040; LOT: 8235. DATE OF SURGERY: (B)(6) 2016. REVISION SURGERY.

  Patient problems: No Code Available; Pain

  MAUDE report 8903524 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8566812 ↗
• MalfunctionMar 4, 2019Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  INSERT LOOSEN. IT WAS REPORTED THAT INSERT COULD NOT MATCH WITH TIBIAL TRAY IN LEFT KNEE REPLACEMENT. IT WAS NOTED IMPLANT LOOSEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8387225 ↗
• InjuryMay 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 BY REPLACING THE INSERT DUE TO POSTOPERATIVE INFECTION, AND DEBRIS CLEANING WAS PERFORMED.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7497846 ↗
• InjuryJun 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. PATIENT CAN ONLY ACHIEVE 95 DEGREE FLEXION.

  Patient problems: Pain

  MAUDE report 6659728 ↗

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