ATTUNE 1516-20-707Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295045908), received between Jan 26, 2018 and Nov 7, 2025 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF FEELING UNSTABLE WHILE WALKING. AFTER X-RAYS AND AND EXAMINING PATIENT IT WAS DECIDED THAT THE SURGEON WAS GOING TO REPLACE THE CR POLY THAT THE PATIENT HAD IN HIS KNEE WITH A MEDIAL STABILIZING BEARING. CR POLY WAS REMOVED AND REPLACED WITH THE MS BEARING AFTER FULL WASH OUT AND DEBRIDEMENT OF SCAR TISSUE. DATE OF ORIGINAL IMPLANTATION IS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 23496657 ↗
• MalfunctionMar 7, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THERE WAS THE WRONG INLAY IN IN THE BOX FOR A KNEE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547259 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED THE OLD POLY AND PUT A NEW POLY IN DUE TO INFECTION. HE THOROUGHLY IRRIGATED AND DRAINED THE INFECTED AREA. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19536557 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT AN I&D WITH POLY EXCHANGE ON RIGHT KNEE. THERE WAS NO SURGICAL DELAY. DOWNSIZED POLY THICKNESS. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323682 ↗
• InjuryFeb 15, 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 45.7 MONTHS. REASON FOR REVISION: INFECTION".

  Patient problems: Unspecified Infection

  MAUDE report 16378207 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISIONS DUE TO PAIN, STIFFNESS, AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2020. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 15968641 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2022, (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REMOVED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15485115 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2022 (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT AND INSERT REMOVED.

  Patient problems: Fall; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15217411 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. DOI: (B)(6) 2018; DOR: 2021 LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13167890 ↗
• InjurySep 15, 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 OSTEOLYSIS AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2016, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Osteolysis

  MAUDE report 12473676 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MID-FLEXION INSTABILITY AND PAIN. THE POLY SIZE WAS INCREASED FROM 7X7 TO 7X10. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11179107 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TO TREAT OSTEOARTHRITIS. INTRAOPERATIVELY, THE SURGEON IDENTIFIED MEDIAL COMPARTMENT ARTHRITIC CHANGES. THE SURGEON NOTES THE PATIENT HAS A HISTORY OF TIBIAL PLATEAU FRACTURE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN SECONDARY TO TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, THE SURGEON EXCISED SCAR TISSUE AND PERFORMED A COMPLETE SYNOVECTOMY. THE TIBIAL TRAY WAS LOOSENED AT THE CEMENT TO IMPLANT INTERFACE AND EASILY REMOVED. THE FEMORAL COMPONENT AND PATELLA WERE WELL FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT RECEIVED AN ATTUNE REVISION TRAY AND STEM UTILIZING UNKNOWN CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 10488016 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISED TO ADDRESS ANKYLOSIS (STIFFNESS) OF THE KNEE, INVOLVING ARTHROTOMY, ARTHROLYSIS, AND EXCHANGE OF THE POLYETHYLENE TIBIAL INSERT COMPONENT. FEMUR, TIBIAL TRAY, AND PATELLA COMPONENTS WERE RETAINED. COMPETITOR BONE CEMENT WAS USED DURING PRIMARY SURGERY. DOI: (B)(6) 2015; DOR: (B)(6) 2016; (RIGHT SIDE).

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9538141 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO ADVANCED DEGENERATIVE ARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. PRIMARY IMPLANT INFORMATION PROVIDED ON PAGE 7-8. COMPETITOR CEMENT WAS UTILIZED AT THE PRIMARY PROCEDURE. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO ASEPTIC LOOSENING, PAIN AND SWELLING. UPON ENTERING THE JOINT, EXTENSIVE SCAR TISSUE WAS ENCOUNTERED. THE FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED BUT REVISED. THE TIBIAL COMPONENT WAS LOOSE, INTERFACE NOT PROVIDED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017. DOR: (B)(6) 2018. (RIGHT KNEE).

  Patient problems: Adhesion(s); Edema; No Code Available; Pain

  MAUDE report 9409671 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE AND HEAVY AMOUNT OF SCAR TISSUE ESPECIALLY AROUND THE PATELLA. IT WAS ALSO REPORTED THAT AFTER REMOVAL OF IMPLANTS, BONE QUALITY AND DEFECTS (FX) - VERY SOFT BAD BONE. THE SURGEON OPTED FOR HINGED COMPONENT. THERE WAS A SURGICAL DELAY OF 25 MINS. DOI: (B)(6) 2018. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available; Not Applicable; Pain

  MAUDE report 9208389 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED (B)(6) 2019 AND WERE REVIEWED (B)(6) 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND UNKNOWN BONE CEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY AND PAIN. THE SURGEON REPORTED NO GROSS ABNORMALITIES NOR LOOSENING TO ANY OF THE COMPONENTS, THOUGH THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED. HE INDICATED THE PATELLA TRACKED NICELY AND WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2018; (LT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9176846 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LATERAL INSTABILITY BETWEEN THE FEMORAL COMPONENT AND THE POLYETHYLENE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9141544 ↗
• MalfunctionJun 25, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT WOULD NOT LOCK INTO TIBIAL BASE. DOE: (B)(6) 2019.

  Patient problems: Not Applicable

  MAUDE report 8730703 ↗
• InjuryFeb 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON DID A POLY SWAP. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7295700 ↗
• InjuryJan 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT UNDERWENT A POLY EXCHANGE FOR INFECTION, PAIN, AND DISCOMFORT ON (B)(6) 2014. THE PATIENT HAD A PREVIOUS REALIGNMENT AND ARTHROTOMY ON (B)(6) 2014 FOR FLEXION INJURY, INSTABILITY, AND PARTIAL QUAD RUPTURE WITH NO REVISION OF PRODUCTS. (B)(6) 2014; (B)(6) 2014 (RIGHT KNEE).

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 7221267 ↗