ATTUNE 1516-30-905Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295048220), received between Jun 20, 2018 and Feb 25, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

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

  WASHOUT OF RIGHT KNEE WAS PERFORMED DUE TO INFECTION. RIGHT INSERT 9X5 RP CR WAS CHANGED. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24445393 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WASHOUT FOR INFECTION LEFT KNEE ATTUNE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24404229 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP PERFORMED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22004134 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WASH OUT FOR INFECTION WITH INSERT EXCHANGE WAS REQUIRED.

  Patient problems: Unspecified Infection

  MAUDE report 20521415 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT DUE TO INFECTION. DURING THE PROCEDURE, THE SURGEON EXCHANGED THE POLYETHYLENE BEARING FOR A NEW ONE OF THE SAME SIZE. THIS WAS A SIZE 9 CRUCIATE RETAINING ROTATING PLATFORM, 5 MM BEARING. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18228868 ↗
• InjuryFeb 15, 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 13.9 MONTHS. REASON FOR REVISION: INFECTION."

  Patient problems: Unspecified Infection

  MAUDE report 16378415 ↗
• 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 1.7 MONTHS. REASON FOR REVISION: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16362626 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING OF PAIN IN THE LEFT KNEE SINCE HAVE THE PRIMARY SURGERY WHICH WAS DONE ON THE (B)(6) 2022 BY DR G K AT SPORTMED. PATIENT THEN SAW DR T S AND AFTER SCANS AND ASSESSMENT FELT THE PATIENT MAY HAVE HAD SOME TISSUE IMPINGEMENT WHICH WAS CAUSING THE PAIN FOR THE PATIENT IN HIS LEFT KNEE. PATIENT WAS REVISED TODAY, IMPINGEMENT WAS FOUND, TIBIAL INSERT WAS REVISED DUE TO THE SURGEON WANTING TO CLEAN THE BACK OF THE KNEE OUT OF SCAR TISSUE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

  Patient problems: Adhesion(s); Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 15788347 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE ARTHROFIBROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2021. (LEFT KNEE). TREATMENT: NONE.

  Patient problems: Adhesion(s)

  MAUDE report 15162690 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT SIDE.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 12703559 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT FAIL, THE PATIENT WAS EXPERIENCING MEDIAL FLEXION INSTABILITY MEDIAL SIDE, POSTERIOR OSTEOPHYTE -- THE SURGEON ADJUSTED THE FEMORAL COMPONENT'S ROTATION TO CLOSE THE GAP. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12689155 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT FOR INFECTION. INSERT CHANGED. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12656511 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2021 WHERE AN ATTUNE UNCEMENTED TIBIAL COMPONENT AND AN ATTUNE UNCEMENTED FEMORAL COMPONENT WAS UTILISED. SURGEON MENTIONED THAT HE WAS REQUIRED TO UNDERTAKE MANIPULATION UNDER ANAESTHESIA (MUA) PATIENT CONSEQUENCE DESCRIPTION/ A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT: LIMITED ROM, STIFFNESS.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11884076 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11616287 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT TOTAL LEFT 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 3. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LIGAMENTOUS INSTABILITY, EFFUSIONS, LIMITED MOTION, AND TIBIAL LOOSENING. THE SURGEON INDICATED THE TIBIAL COMPONENT HAD COMPLETELY DE-BONDED FROM THE TIBIA CEMENT LEAVING 100% OF THE CEMENT INTACT WITH THE BONE INTERFACE. LOOSENING AT THE TRAY/CEMENT INTERFACE. HE NOTED THE FEMORAL COMPONENT WAS REMOVED WITH RECIPROCATING SAW AND OSTEOTOME. THE SURGEON REPORTED THE PATELLA WAS REVISED TO REDUCE THE THICKNESS FOR IMPROVED FLEXION. THE PATIENT WAS IMPLANTED WITH ATTUNE KNEE SYSTEM AND UNKNOWN BONE CEMENT. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2018; DOR: (B)(6) 2019 (LT KNEE).

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9362500 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT AND CHANGE OF POLY RIGHT ATTUNE TOTAL KNEE REPLACEMENT: THE PATIENT UNDERWENT PRIMARY TKR. PRESENTED BACK TO THE SURGEON WITH SIGNS OF INFECTION. DEBRIDEMENT AND WASHOUT AND CHANGE OF POLY INSERT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8336930 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE.

  Patient problems: No Code Available; Pain; Scarring

  MAUDE report 8016160 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED DUE TO CONTINUED PAIN. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable; Pain

  MAUDE report 7620997 ↗