ATTUNE 1516-40-805Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10603295050346), received between Dec 22, 2017 and Sep 23, 2026 — classified as 73 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (6 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 79 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that ATTUNE PS FEM LT SZ 8 CEM, ATTUNE PS FB INSRT SZ 8 5MM, and ATTUNE FB TIB BASE SZ 7 CEM were involved in a left knee total knee arthroplasty revision case. The patient was reportedly unable to rehabilitate the knee after surgery and had very limited motion of 15 to 40 degrees. Revision surgery was performed to address the condition. During the procedure, all components were described as well fixed and well aligned, and no allegation was made against any of the components. A difficult exposure was performed with tissue elevation and removal of scarring. All well-fixed components were removed, and the revision total knee arthroplasty was completed without delay or patient harm. Range of motion was reported to be quite good, and a good outcome was expected. The cement was described as likely DePuy 2, hand mixed in an open bowl per surgeon protocol. The implanted devices were explanted.Affected Side: Left Knee

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 50868758 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED; IMPLANTS REMOVED BECAUSE OF INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24575637 ↗
• MalfunctionMar 9, 2026Difficult to Insert

  IT WAS REPORTED THAT THE INSERT DOES NOT FIT PROPERLY INTO THE TIBIAL TRAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545195 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23855440 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGERY WAS ON THE RIGHT SIDE AND THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 23486618 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23347996 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A HEMATOMA, POLY SWAP AND WASHOUT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 23025449 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION IN THE TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND A STAGED ANTIBIOTIC SPACER WAS PLACED BY THE SURGEON. THERE WAS NO DELAYS IN SURGERY OR ANY PATIENT INJURY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22496555 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION TO TREAT PAIN AND JOINT INSTABILITY SECONDARY TO ASEPTIC LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE TIBIAL TRAY WAS FOUND TO BE LOOSENED AND DEBOUNDED AT THE COMPETITOR CEMENT TO IMPLANT INTERFACE. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT AND PATELLA WERE WELL-FIXED AND RETAINED. THE PATIENT RECEIVED AN ATTUNE REVISION CONSTRUCT SECURED WITH COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22087742 ↗
• MalfunctionMay 19, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE IMPLANT DIDN¿T CLIP IN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046240 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER EXCHANGE TO RULE OUT INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20135070 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE A LINER EXCHANGE HAD BEEN PERFORMED TO RULE OUT INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20051016 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WAS THERE ANY ALLEGATION AGAINST THE FEMUR AND INSERT? FEMUR: PARTIAL LOOSENING SUSPECTED WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT.

  Patient problems: Pain

  MAUDE report 19656799 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE JOINT INFECTION. KNEE WAS WASHED OUT AND THE POLY WAS SWAPPED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19312071 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENT AT FIRST POST OP VISIT WITH A DRAINING KNEE. SURGEON CHOOSES TO DO AN I&D WITH EXCHANGE OF POLY AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. FOR REFERENCE, THE PATIENT HAD A PREVIOUS TIBIAL PLATEAU FRACTURE PRIOR TO HIS KNEE REPLACEMENT. THERE WAS NO PATIENT HARM AND NO DELAY OCCURRED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 19164769 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 POLY EXCHANGE WAS DONE DUE TO INSTABILITY. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19072038 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR I&D DUE TO INFECTION, EXCHANGED POLY, NO OTHER INFORMATION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18148262 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND SWAPPED POLY WHILE IN JOINT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Insufficient Information

  MAUDE report 17823666 ↗
• InjuryAug 24, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT COMPLAINING TO SURGEON OF 'CLICKING' IN RIGHT KNEE REPLACEMENT. THE SURGEON PERFORMED ARTHROSCOPY ON PATIENT'S RIGHT KNEE AND OBSERVED THE POLY INSERT TO BE LOOSE. CONVERTED TO OPEN PROCEDURE WHERE IT WAS DISCOVERED THE POLY INSERT WAS NOT ENGAGED IN THE TIBIAL TRAY AND WAS LOOSE. POLY INSERT REMOVED, DEBRIDEMENT AND WASHOUT PERFORMED AND NEW POLY INSERT OF SAME THICKNESS INSERTED (SIZE 8/5MM). DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 17611269 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17143551 ↗
• MalfunctionApr 24, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGERY WAS PERFORMED VIA TKA. IN THE SURGERY, THE SURGEON FIXED TIBIAL TRAY (NO. 7) AND FEMUR PS RIGHT (NO. 8) WITH CEMENT. WHEN HE INSERTED THE INSERTER PS 5 MM (NO.8), IT WENT IN EASILY WITH LITTLE EFFORT. WHEN HE CHECKED, THE BACK WAS FLOATING, AND THE INSERTER WAS NOT INSTALLED CORRECTLY. NO MATTER HOW MANY TIMES HE TRIED, HE COULD NOT INSTALL IT CORRECTLY. HE CHANGED THE INSERTER TO PS 6 MM(NO.8) AND IT WAS INSTALLED CORRECTLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. HE COMMENTED THAT THE LOCKING MECHANISM MUST HAVE BEEN BROKEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795791 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: ON (B)(6) 2022. DOR: ON (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16512553 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT NEEDED A THICKER POLY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16451829 ↗
• InjuryFeb 14, 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 3.6 MONTHS. REASON FOR REVISION: INFECTION".

  Patient problems: Unspecified Infection

  MAUDE report 16371140 ↗
• InjuryFeb 13, 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 5.1 MONTHS. REASON FOR REVISION: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16364110 ↗

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