ATTUNE 1518-10-035Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10603295056638), received between Aug 10, 2017 and Sep 25, 2026 — classified as 146 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (14 reports).

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 152 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50904655 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that implants removed due to infection. No patient consequence. No surgical delay.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Right.

  Patient problems: Unspecified Infection

  MAUDE report 50871727 ↗
• InjuryJul 17, 2026Fracture

  IT WAS REPORTED THAT PATIENT FELL AND PATELLA SHEARED OFF. NO OTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall

  MAUDE report 25861490 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALLING AFTER TOTAL KNEE REPLACEMENT. DOI: (B)(6) 2026, DOR: (B)(6) 2026 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 25349185 ↗
• InjuryJun 1, 2026Loss of or Failure to Bond; Fracture

  IT WAS REPORTED THAT AN ATTUNE CEMENTED 35MM ANATOMIC PATELLA SHEARED OFF THE BONE. THERE WAS LOOSENING OF ATTUNE CEMENTED 35MM ANATOMIC PATELLA AT CEMENT IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. THE PEGS WERE NOT ON THE EXPLANTED PATELLA AND HAD MIGRATED OUT OF THE BONE. DOI: (B)(6) 2020. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching

  MAUDE report 25348871 ↗
• InjuryMay 5, 2026Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION. DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 150401104. LOT NUMBER: 3793392. COMPONENT TYPE: FEMORAL. DESCRIPTION: ATTUNE CR FEM LT SZ 4 POR. CATALOG NUMBER: 150621004. LOT NUMBER: JA04A0460. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB TIB BASE SZ 4 POR. CATALOG NUMBER: 151820406. LOT NUMBER: M83K02. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 4 6MM. CATALOG NUMBER: 151810035. LOT NUMBER: 4689234. COMPONENT TYPE: PATELLAR. DESCRIPTION: ATTUNE MEDIAL ANAT PAT 35MM. CATALOG NUMBER: 3322020. LOT NUMBER: 4494872. COMPONENT TYPE: PATELLAR. DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Insufficient Information

  MAUDE report 25081210 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED DUE TO INFECTION. STAGE 1 OF 2 KNEE REVISION WAS PERFORMED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24874613 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AND ALL COMPONENTS AND CEMENT WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24581421 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SPACER WAS EXPLANTED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24426782 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH STAGE 1 OF 2 REVISION. ANTIBIOTIC SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23879106 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE PS FEM RT SZ 6 NAR CEM, ATTUNE RP TIB BASE SZ 5 CEM, ATTUNE MEDIAL ANAT PAT 35MM, AND ATTUNE PS RP INSRT SZ6 5MM WERE INVOLVED IN A REVISION OF AN ATTUNE KNEE SYSTEM DUE TO PERSISTENT PAIN FOLLOWING THE INITIAL PROCEDURE. ALTHOUGH TESTS FOR INFECTION AND LOOSENING WERE NEGATIVE, ELEVATED BLOOD MARKERS LED CLINICIANS TO TREAT THE CASE AS AN INFECTION, RESULTING IN A TWO-STAGE REVISION WHERE ALL COMPONENTS WERE EXPLANTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23819075 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEW REVISION DUE TO TIBIA CUT MADE IN VALGUS. PATIENT UNHAPPY WITH ALIGNMENT. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770188 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION AND SPACER WAS PLACED FOR INFECTION. NO FURTHER INFORMATION IS AVAILABLE. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23569497 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23547281 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN/INSTABILITY. DOI- UNKNOWN. DOR-(B)(6) 2025. AFFECTED SIDE- RIGHT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23535085 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS INFECTED WITH MERSA SO ALL OF HER PREVIOUS IMPLANTS WERE TAKEN OUT TO BE REPLACED WITH ANTIBIOTIC SPACERS. NO PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 23289773 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION FOR ANTERIOR KNEE PAIN. THE SURGEON REMOVED ANATOMIC PATELLA / SHAVED DOWN REMAINING BONE / REIMPLANTED DOME PATELLA. CHANGED TO MORE CONSTRAINT POLY AND COMPLETED LATERAL FACETECTOMY. THERE WAS NO DELAY IN SURGERY. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED OR SUCCESSFULLY COMPLETED.

  Patient problems: Pain

  MAUDE report 22903752 ↗
• InjuryAug 26, 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 PREVIOUS INFECTION AND UNEXPLAINED PAIN. A POLY EXCHANGED WAS PERFORMED. A FULL REVISION WAS DONE AND FULL DEBRIDEMENT PERFORMED PRIOR TO IMPLANTATION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22897421 ↗
• InjuryJul 25, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE ATTUNE PRIMARY KNEE REQUIRED REVISION DUE TO LOOSENING AND PAIN.

  Patient problems: Pain

  MAUDE report 22607655 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 PATIENT HAD UNDERWENT RIGHT KNEE WITH VELYS. ON (B)(6) 2025, PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO PAIN, SWELLING, AND INSTABILITY. PATIENT WAS FOUND TO HAVE ASEPTIC FEMORAL AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS UNDERLYING FIBROUS TISSUE AND THE CEMENT WAS REMOVED AFTER THE TIBIAL COMPONENT AND FEMORAL COMPONENTS WERE REMOVED. THE PATELLA WAS NOTED TO HAVE BEEN REMOVED AS WELL, BUT THERE WAS NO MENTION IMPLANT LOOSENING RELATED TO THE PATELLA. COMPETITOR IMPLANTS WERE PLACED AT REVISION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fibrosis; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21882059 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT POLY SWAP. PATIENT FELL AND FRACTURED PATELLA BONE. PATELLA POLY AND ART POLY WERE REVISED. PATELLA COMPONENT WAS NOT LOOSE. NO SURGICAL DELAY DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 21773200 ↗
• InjuryJan 22, 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) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21206972 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS GROSSLY INFECTED. PATIENT FELL AND SPLIT OPEN KNEE. REMOVED ALL IMPLANTS. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection; Wound Dehiscence

  MAUDE report 20843966 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A STAGE 1 KNEE REVISION TO RULE OUT INFECTION. THERE WAS NO SURGICAL DELAY, AND NO SECOND STAGE REVISION WAS PERFORMED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20745472 ↗
• InjuryNov 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR PATELLA DISLOCATION DUE TO FALLING. SURGEON SWAPPED OUT THE POLY. THERE WAS NO SURGICAL DELAY, DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 20585987 ↗