ATTUNE 1516-20-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295045892), received between Jul 13, 2017 and Sep 30, 2026 — classified as 37 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain.Affected side: Left knee.

  Patient problems: Pain

  MAUDE report 50944879 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING AND INFECTION. THERE WAS LOOSENING OF THE FEMUR AND TIBIA. THE CEMENT MANUFACTURER WAS UNKNOWN. NO LOT NUMBERS ARE AVAILABLE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25395166 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO LAXITY IN THE KNEE. UPSIZE POLY TO THICKER SIZE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23960542 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION FROM CAT SCRATCH. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23290690 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INSERT EXCHANGE AND I&D. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23050023 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD WOUND DEHISCENCE WITH TORN RETINACULUM. DOCTOR WASHED OUT THE KNEE AND SWAPPED THE POLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 22020013 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS KNEE WAS GLOBALLY LOOSE. THE PATIENT EXCHANGED THE 6MM ATTUNE CR FB POLY FOR A 10MM MS LEFT POLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21942501 ↗
• InjuryFeb 28, 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 KNEE PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18803716 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR WASHOUT OF INFECTED KNEE POLY EXCHANGE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18441010 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REMOVAL OF POLY TO REMOVE SOME SCAR TISSUE. REPLACED POLY AFTER. NOTHING MORE TO REPORT. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 18170782 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS BILATERAL KNEE INFECTIONS. SWAP THE LEFT AND RIGHT INSERTS. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16853001 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2015, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS ARTHRITIS. DEPUY COMPONENTS ALONG WITH COMPETITOR CEMENT WAS IMPLANTED DURING THE PROCEDURE. ON (B)(6) 2022, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE TO ADDRESS FAILED RIGHT TOTAL KNEE. THE INDICATIONS FOR SURGERY INCLUDED PERSISTENT PAIN, SUSPICION FOR INFECTION WITH INFLAMMATORY MARKERS AND ASPIRATION; HOWEVER, IMAGING CONSISTENT WITH ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. DURING THE PROCEDURE, THE SURGEON OBSERVED SOME GRAYISH STAINING OF THE TISSUE CONSISTENT WITH SOME MECHANICAL MOTION OF THE COMPONENTS. TIBIAL COMPONENT POPPED FREE FROM CEMENT CONSISTENT WITH LOOSENING SEEN CONSISTENTLY WITH FIRST GENERATION ATTUNE TIBIAS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE INCLUDING DEPUY CEMENT.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Synovitis; Unspecified Infection; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 16545926 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S PRIMARY KNEE WAS REVISED DUE TO INFECTION. DURING THE REVISION PROCEDURE, HIS PRIMARY ATTUNE FB CR TIBIAL INSERT WAS REMOVED. THE SURGEON THEN THOROUGHLY IRRIGATED AND DEBRIDED THE PATIENT'S KNEE CAPSULE, AND THEN IMPLANTED A REPLACEMENT INSERT. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16145559 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NEW POLY IMPLANTED. NO FURTHER INFORMATION AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16141125 ↗
• InjuryDec 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT UNDERWENT ATTUNE TKR ON (B)(6) 2022. PRESENTED BACK TO THE SURGEON COMPLAINING OF PAIN. SURGEON PERFORMED AN ARTHROSCOPE AND NOTED THE POLY APPEARED 'NOT ENGAGED AND SITTING UP'. PLAN TO CHANGE POLY AND INVESTIGATE THE KNEE. DEBRIDEMENT AND POLY REMOVED. SURGEON NOTED THE POLY 'WAS NOT ENGAGED AND CAME OUT EASILY WITH A SMALL AMOUNT OF FORCE'. KNEE WAS DEBRIDED AND A NEW POLY INSERTED OF THE SAME THICKNESS. SURGEON WAS SATISFIED WITH THE STABILITY AND FIXATION OF THE POLY.

  Patient problems: Pain

  MAUDE report 15931659 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXHIBITED PAIN AND SWELLING. SURGEON DID WORK UP FOR INFECTION, DETERMINED IMPLANT NEEDED TO BE EXPLANTED ON FAVOR OF ANTIBIOTIC SPACER. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15236832 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSTABILITY OF THE PROSTHESIS AFTER POST-FRACTURE OF THE DISTAL FEMUR. SURGICAL PROCEDURE: TOTAL KNEE PROSTHESIS FOR REVISION OF MEDIAL UNICOMPARTMENTAL PROSTHESIS. BETWEEN THE IMPLANTATION OF THE CR ATTUNE DEPUY PROSTHESIS AND THE REVISION THERE WAS A SUPRACONDYLAR PERIPROSTHETIC FRACTURE FROM TRAUMA (NOT CONNECTED TO THE PROSTHESIS OR TO ITS INSTABILITY), WHICH IS TO BE CONSIDERED THE MAIN RESPONSIBLE FOR THE INSTABILITY THAT WE HAVE COME TO TREAT WITH THE REVISION. FOR THE REST, IT WAS A TOTAL EXPLANTATION OF COMPONENTS THAT WERE WELL ADHERED TO THE BONE. DOI: (B)(6) 2019, DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14487509 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RETINACULAR REPAIR WAS DONE AND DECIDED TO GO 1MM THINNER ON THE POLY FOR ROM. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Unspecified Musculoskeletal problem

  MAUDE report 14159538 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REPLACED ON (B)(6) 2021 BY A SURGEON, AT THE SAME HOSPITAL. APPROXIMATELY TWO WEEKS LATER, THE PATIENT FELL AND BUSTED OPEN HIS INCISION SITE. SURGEON WITH THE ASSISTANCE OF THE OTHER SURGEON, IRRIGATED AND DEBRIDED THE PATIENT'S KNEE. THEY ALSO SWAPPED OUT THE PRIMARY ATTUNE INSERT FOR A REPLACEMENT INSERT (B)(4). A LITTLE MORE THAN TWO WEEKS LATER, THE PATIENT'S KNEE BECOME INFECTED, SO SURGEON IRRIGATED AND DEBRIDED IT A SECOND TIME. SWAPPED OUT THE INSERT A SECOND TIME AS WELL. DOI: (B)(6) 2022 (B)(4); DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13472050 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A TOTAL KNEE RECONSTRUCTION PROCEDURE PERFORMED ON HIS RIGHT KNEE LAST (B)(6) 2021 BY SURGEON AT THE SAME HOSPITAL. APPROXIMATELY TWO WEEKS LATER, THE PATIENT FELL AND BUSTED OPEN HIS INCISION SITE. SURGEON WITH ASSISTANCE OF ANOTHER SURGEON, WASHED OUT (IRRIGATED AND DEBRIDED) THE PATIENT'S KNEE, SWAPPED OUT THE PRIMARY ATTUNE INSERT WITH A REPLACEMENT INSERT AND RECLOSED THE INCISION SITE. DOI: (B)(6) 2021 ; DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 13306619 ↗
• MalfunctionOct 27, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE 7X6 MM ATTUNE CR FB TIBIAL INSERT WAS IMPLANTED AND IMMEDIATELY FELT TIGHT AND THE SURGEON WASN¿T SURE IF IT COMPLETELY LOCKED IN. THE SURGEON THEN REMOVED THE POLY AND DISCOVERED THAT THE LOCKING TAB ANTERIORLY WAS BENT OUT BUT HE WASN¿T SURE IF IT WAS LIKE THAT PREVIOUSLY OR IF IT WAS DAMAGED REMOVING IT. BACKUP INSERT WAS AVAILABLE SO THIS DID NOT EFFECT THE PATIENT/CASE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704040 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH PAIN, STIFFNESS AND POOR RANGE OF MOTION (90 DEGREES) AND THAT THE REASON FOR REVISION WAS AN "OVERSIZED FEMORAL COMPONENT - REVISION TO DOWNSIZE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 12149440 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO SEVERE DEGENERATIVE JOINT DISEASE AND FLEXION CONTRACTURE. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, DECREASED RANGE OF MOTION. INITIALLY, MANIPULATION UNDER ANESTHESIA AND JOINT ASPIRATION WAS PERFORMED THAT PROVIDED TEMPORARY RELIEF, IT WAS THEN DETERMINED A REVISION WAS NEEDED. UPON ENTERING THE JOINT, SIGNIFICANT SCAR TISSUE WAS ENCOUNTERED AND REMOVED. THE FEMORAL AND PATELLA COMPONENTS WERE NOT REVISED, NO INDICATION OF DEFICIENCY. THE TIBIAL COMPONENT WAS SUBSIDED AND LOOSE AT THE CEMENT TO IMPLANT INTERFACE. TIBIAL INSERT REVISED WITHOUT INDICATION OF DEFICIENCY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016 DOR: (B)(6) 2019 LEFT KNEE.

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

  MAUDE report 11738446 ↗
• MalfunctionJan 27, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A 30-MINUTE SURGICAL DELAY. THE REPORTED EVENT INCREASED THE PATIENT'S RISK OF INFECTION. AFFECTED SIDE IS THE RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11237401 ↗
• MalfunctionJan 27, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A 30-MINUTE SURGICAL DELAY. THE REPORTED EVENT INCREASED THE PATIENT'S RISK OF INFECTION. AFFECTED SIDE IS THE RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11237378 ↗