ATTUNE 1516-30-807Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295048121), received between Aug 23, 2018 and Nov 26, 2025 — classified as 17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23654053 ↗
• InjuryMay 17, 2024Adverse 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 POLY WAS UPSIZED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19340519 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IMPLANT DATE AND HOSPITAL UNKNOWN. THERE WAS NO DELAY. DOI- UNKNOWN, DOR- (B)(6) 2023, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17962446 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6)2023. DATE OF REVISION: (B)(6)2023 (LEFT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 17390692 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND DID A WASHOUT WITH POLY EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16417547 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(4) 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 17.8 MONTHS. REASON FOR REVISION: INSTABILITY."

  Patient problems: Joint Laxity

  MAUDE report 16370971 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A WASH OUT AND POLY EXCHANGE DUE TO POSSIBLE INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16050977 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A KNEE PAIN. CULTURES AND TISSUE SAMPLES WERE SENT FROM THE KNEE. NO LOOSENING OF THE COMPONENTS. CHANGED OUT POLY TO SAME SIZE AS PREVIOUS IMPLANTED. DOI: (B)(6) 2020; DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15209715 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED PERFIX PLUG ON (B)(6) 2018 AND 3DMAX LIGHT ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALSO ALLEGES THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Joint Laxity

  MAUDE report 14487849 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS INFECTION. A BILATERAL KNEE WAS REVISED. DID I&D/POLY SWAP OF BOTH KNEES. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE. CAPTURES THE IMPLANT: ATTUNE CR RP INSRT SZ 8 7MM (151630807/8714344).

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

  MAUDE report 12441091 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A BILATERAL ATTUNE TOTAL KNEE. THE RIGHT PATELLA WAS RESURFACED AND UNKNOWN CEMENT WAS UTILIZED. ONLY PARTIAL PRIMARY NOTE WAS ILLEGIBLE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE REMOVAL OF A LARGE ANTEROLATERAL CYST THAT WENT DISTALLY FOR ABOUT 3 TO 3.5 CM. THE TIBIAL TRAY AND TIBIAL INSERT WERE REVISED. THE PATELLAR AND FEMORAL COMPONENTS WERE RETAINED. THE PATIENT WAS REVISED WITH DEPUY ATTUNE REVISION COMPONENTS AND COMPETITOR CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 20215, DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Cyst(s)

  MAUDE report 11780739 ↗
• InjuryJan 7, 2021Unintended Movement; Unintended Movement

  BEARING SPUN OUT KNEE DISLOCATED.

  Patient problems: Joint Dislocation

  MAUDE report 11133753 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HEMATOMA PURULENT FLOW ON LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Purulent Discharge

  MAUDE report 10408274 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019: TRANSFERRED TO OPERATING ROOM FOR TRIMMING, CLEANING, POLYETHYLENE CHANGE AND CRIOGO SAMPLES. CEFEPIME + ZYVOXIDE POST-OPERATIVELY. POST-OPERATIVE HEMOGLOBIN 8.8, RECEIVED TWO UNITS OF RED BLOOD CELLS. DOI: (B)(6) 2019 .DOR: (B)(6) 2019 ;LEFT KNEE.

  Patient problems: Edema; No Code Available; Pain; Rash

  MAUDE report 9510680 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OSTEOARTICULAR INFECTION ON LEFT KNEE TKA. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Hematoma; No Code Available; Unspecified Infection

  MAUDE report 9329868 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT LEG THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Edema; Muscular Rigidity; No Code Available; Pain; Rash; Thrombosis; Unspecified Infection

  MAUDE report 9329794 ↗
• InjuryAug 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  WASHOUT AND TIBIAL INSERT CHANGE: DR (B)(6), (B)(6) HOSPITAL, (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2018. REMOVAL OF TIBIAL INSERT AND REPLACED WITH NEW INSERT DUE TO INFECTION. NO AE TO THE PATIENT. PATIENT INITIAL: (B)(6) , MALE, DOB: (B)(6).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7810542 ↗