ATTUNE 1516-40-807Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295050360), received between Jul 27, 2017 and Aug 5, 2026 — classified as 32 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had in attune total knee. It was being washed out due to infection. Surgeon removed the poly and replaced with a new tibial insert.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50139791 ↗
• InjuryDec 24, 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 23888108 ↗
• InjuryDec 5, 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 PERSISTENT PAIN LEFT KNEE. PATIENT HAD RETAINED HARDWARE FROM PRIOR ACL SURGERY. BONE SCAN SHOWED SOME UPTAKE ON BOTH FEMUR AND TIBIA COMPONENTS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23729197 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A WASHOUT I&D WITH POLY SWAP. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22965166 ↗
• InjuryMay 12, 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 AFTER KNEE SURGERY DUE TO POSSIBLE INFECTION. THERE WAS A WASH OUT POLY EXCHANGE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22004322 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED A HEMATOMA AND HAD A LACK OF EXTENSION. THEREFORE, THE SURGEON DECIDED TO SWAP OUT THE POLY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hematoma; Loss of Range of Motion

  MAUDE report 21608417 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED POST TKA WITH POOR MOTION AND A KNEE REVISION IS SCHEDULED. AFTER ANESTHESIA IS PERFORMED, A MANIPULATION IS PERFORMED AND FLEXION IS FOUND TO BE SATISFACTORY, HOWEVER FULL EXTENSION IS NOT ABLE TO BE OBTAINED AND A FEMORAL SIDE REVISION IS PERFORMED UNEVENTFULLY WITH NO DELAY AND NO PATIENT HARM IS NOTED. FULL EXTENSION IS ACHIEVED WITH MINIMAL BONE RESECTION OF THE FEMUR AND POSTERIOR CAPSULAR RELEASE. A LATERAL RELEASE WAS ALSO PERFORMED TO ALLOW FOR BETTER PATELLAR TRACKING. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 21061259 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20916016 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION AND HAD A POLY EXCHANGE AND I&D FOR CONFIRMED INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17197513 ↗
• InjuryFeb 15, 2023Naturally Worn; Naturally Worn

  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 32.3 MONTHS. REASON FOR REVISION: TIBIAL LOOSENING, PAINFUL, POLY WEAR, SUBSIDENCE, INSTABILITY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16378115 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO A FALL AND OPENED INCISION. THERE WAS NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 16225503 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED LEFT KNEE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: ON (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16091353 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD (B)(6) 2022. PATIENT UNDERWENT BILATERAL KNEE REPLACEMENTS ON (B)(6) 2022. LEGAL CLAIM ALLEGES THE PATIENT SUFFERED FROM PAIN, DISABILITY, AND ADDITIONAL SURGERY. NO PRIMARY OR REVISION NOTES HAVE BEEN PROVIDED - ONLY THE PART/LOT INFORMATION FOR THE IMPLANTS PLACED. THIS PC CAPTURES THE LEFT KNEE WHICH IS CAPTURED ON PAGES 4 AND 5. (B)(4) CAPTURES THE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15690646 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A SUCCESSFUL LEFT PRIMARY TKA UTILIZING ATTUNE IMPLANTS INCLUDING PATELLA AND SMARTSET CEMENT X 1 ON (B)(6) 2014. PATIENT WAS LATER REVISED ON (B)(6) 2022 FOR LOOSENING AND GROSS MIGRATION OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS ALSO REVISED BUT WAS WELL FIXED AND THERE WERE NO ALLEGATIONS AGAINST THE COMPONENT. INTRAOPERATIVE FINDINGS INCLUDED OSTEOLYSIS, BUT DID NOT STATE WHERE THE OSTEOLYSIS WAS FOUND. DOI: (B)(6) 2014. DOR: (B)(6) 2022 (LEFT KNEE).

  Patient problems: Osteolysis

  MAUDE report 15649750 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 15163621 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGE WAS DONE. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 12910026 ↗
• InjuryJul 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS WOUND NECROSIS. THE SURGEON EXTRACTED THE INFECTIOUS FLUID FROM THE JOINT VIA SYRINGE PRE-OPERATIVE. THE SURGEON DID NOT WANT TO PERFORM A WASH OUT AND CHANGED THE POLYETHYLENE AS A PRECAUTIONARY MEASURE. IT WAS ALSO SAID THAT THE CAPSULE WAS INTACT. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

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

  MAUDE report 12224838 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT POLY EXCHANGE DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

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

  MAUDE report 12092812 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. AN I&D AND A POLY EXCHANGED WERE PERFORMED. NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11932485 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SWOLLEN KNEE 9 DAYS POST OP. WASHED OUT WITH ANTIBIOTIC BEADS/ POLY EXCHANGE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 11879301 ↗
• MalfunctionFeb 2, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AT THE END OF THE CASE, DURING CEMENTATION, THE DOCTOR UTILIZED THE FB INSERT IMPACTOR TO IMPLANT THE POLYETHYLENE INSERT. ALMOST IMMEDIATELY AFTERWARDS, HE REQUESTED TO GET ANOTHER POLY INSERT BECAUSE THE FIRST ONE DID NOT SEAT FULLY IN THE BACK OF THE POSTERIOR PORTION OF THE TIBIAL BASE. THE OTHER POLY INSERT FIT OKAY INTO THE TIBIAL INSERT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. SURGERY TIME WAS DELAYED BY A MINUTE OR TWO AT MOST.

  Patient problems: Insufficient Information

  MAUDE report 11265546 ↗
• MalfunctionNov 5, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TKA. THE SURGEON COULD NOT GET THE POLY TO LOCK INTO THE TRAY. A SECOND POLY WAS OPENED & IMPLANTED. A 15 MINUTE SURGICAL DELAY WAS REPORTED. DOE: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10792699 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND CONFIRMED INFECTION. SURGEON WASHED OUT KNEE, REPLACED POLY INSERT ONLY. REPLACED WITH DUPLICATE TIBIAL INSERT. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10164972 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9586496 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT A 2ND RIGHT KNEE REVISION DUE TO LOOSENING TO THE TIBIAL COMPONENT AND INSTABILITY. THE SURGEON REPORTED OSTEOLYSIS OF THE LATERAL POSTERIOR CONDYLE. HE INDICATED THE TIBIAL COMPONENT HAD DE-BONDED FROM THE CEMENT AND THERE WAS NO CEMENT BONDED TO THE TIBIAL COMPONENT. THE SURGEON DID NOT COMMENT ON THE FEMORAL COMPONENT, THOUGH IT WAS REVISED. THE PATELLA WAS RETAINED. THE PATIENT WAS IMPLANTED WITH COMPETITOR KNEE SYSTEM AND COMPETITOR BONE CEMENT. DOI: (B)(6) 2014 (TIBIAL, FEMORAL, PATELLAR COMPONENTS) DOI: (B)(6) 2014 (TIBIAL INSERT). DOR: (B)(6) 2016 (TIBIAL AND FEMORAL COMPONENTS).

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9505910 ↗

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