ATTUNE 1516-20-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295045915), received between Oct 13, 2017 and Jan 2, 2026 — classified as 18 injuries, 2 malfunctions.

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

• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POLY SWAP. KNEE WAS TIGHT, SWITCHED TO A 7 MM POLY FROM 8 MM POLY AND RANGE OF MOTION INCREASED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 23943258 ↗
• InjuryJul 29, 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 PAIN AND INSTABILITY. AFTER ENTERING THE JOINT, THE PATELLA COMPONENT HAD FAILED AT THE BONE/CEMENT INTERFACE AND WAS FLOATING IN THE JOINT. COMPONENTS SHOWED SIGNS OF LOOSENING ON A BONE SCAN. COMPONENTS WERE REMOVED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22641948 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AP WAS UNSTABLE. AFFECTED AREA: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22301508 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN INFECTED RTK, AN I&D OF THE KNEE WAS DONE. POLY INSERT WAS REMOVED TO INCREASE EXPOSURE AND MAKE I&D MORE SUCCESSFUL. THE FEMORAL, TIBIAL AND PATELLA COMPONENTS WERE WELL FIXED AND POSITIONED. THESE PARTS WERE RETAINED. AFTER THE I&D WAS COMPLETE A NEW POLY INSERT WAS INSERTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18408854 ↗
• MalfunctionOct 10, 2023Expiration Date Error; Expiration Date Error

  AN E-MAIL WAS RECEIVED STATING THE FOLLOWING: I INFORM YOU THAT THERE IS NO HEALTH RISK FOR THE PATIENT SINCE FINALLY THE EXPIRED INSERT (B)(4) WAS NOT IMPLANTED. THE SURGEON DECIDED TO CHANGE THE SIZE OF THE INSERT ONCE WE HAD ALREADY OPENED THE INSERT (B)(4) AND FINALLY, ONE MORE SIZE WAS IMPLANTED (B)(4). ATTACHED COPY OF THE PART OF THE SURGERY WHERE THE EXPENSE OF THE 2 INSERTS IS SHOWN (B)(4), AS WELL AS A COPY OF THE SURGERY REPORT WHERE THE SURGEON JUSTIFIES THE REASON FOR THE INSERT CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906898 ↗
• MalfunctionJun 28, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE ATTUNE CR FB CONSTRUCT WAS USED FOR RIGHT TKR. THE TIBIAL INSERT FIXED BEARING WAS SELECTED. WHEN IMPLANT WAS IMPACTED, IT WAS SITTING IN THE TRAY HOWEVER IT WASN'T ENGAGED FULLY. TWO MORE ATTEMPTS WERE MADE TO IMPACT THE IMPLANT. NEW INSERT OF THE SAME TYPE WAS OPENED AND IMPACTED. NO ISSUES WERE REPORTED WITH THE SECOND INSERT. SURGERY WAS DELAYED 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219112 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY EXCHANGE I&D. SWAPPED OUT A CR FB ATTUNE INSERT AND PUT IN A MEDIAL STABILIZED INSERT OF THE SAME SIZE. DOI: UNKNOWN. DOR: APRIL 9, 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16815141 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. PATIENT COMPLAINED OF PAIN. BLOOD WORK INDICATED POSSIBLE INFECTION. PATIENT WAS SCHEDULED FOR A I&D WASH OUT AND POLY EXCHANGE. INTRAOP, THE FEMUR CAME OFF WITH NO FORCE. A CEMENT SPACER WITH ANTIBIOTIC¿S WAS IMPLANTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16637444 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON STATED THE PATIENT HAD A POSSIBLE INFECTION AND CHOSE TO WASH OUT THE KNEE AND CHANGE THE INSERT. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16276968 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION DUE TO INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF REVISION: (B)(6) 2022. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2021. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 16271713 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14645276 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT WAS COMPLAINING OF STIFFNESS. PATIENT WAS SCHEDULED AS A POLY SWAP VS FEMORAL REVISION VS FULL REVISION. POLY WAS EXTRACTED. FEMUR WAS TAPPED ON TO CHECK FIXATION AND IT APPEARED WELL FIXED. TIBIA WAS ALSO TAPPED ON TO CHECK FIXATION AND CAME OUT WITH A FEW TAPS WITH A MALLET ON THE UNDERSIDE OF THE COMPONENT. FEMUR WAS THEN ALSO EXTRACTED AND AN ATTUNE REVISION FB CEMENTED STEM COMPONENT WAS IMPLANTED. PATELLA WAS RETAINED. I WAS ONLY ABLE TO GET THE LOT NUMBER OFF OF THE TIBIAL TRAY. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10670901 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY OF LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: LEFT KNEE TIBIAL INSERT REVISED ON (B)(6) 2020.

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

  MAUDE report 10301487 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS WITH INTRACTABLE PAIN. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY, DECREASED ACTIVITIES OF DAILY LIVING, AND PAIN. THE SURGEON REPORTED THE REMOVAL OF THE FEMORAL COMPONENT WITH CEMENT. THE SURGEON REVISED THE TIBIAL COMPONENT. THE SURGEON NOTED A FAIR AMOUNT OF GRANULATION TISSUE WAS REMOVED FROM THE UNDERSURFACE OF THE PATELLA. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2014; DOR: (B)(6) 2019 (LT KNEE).

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9363005 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, INSTABILITY, ARTHROFIBROSIS, AND ADHESIONS. THE PATELLA COMPONENT WAS NOT REVISED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2018; LEFT KNEE.

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

  MAUDE report 9286917 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED TO ADDRESS FLEXION CONTRACTURE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES. 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. (B)(4). DEVICE PROPERTY OF -->NONE. DEVICE IN POSSESSION OF -->NONE. (B)(4). DEVICE PROPERTY OF -->NONE. DEVICE IN POSSESSION OF -->NONE. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Code Available

  MAUDE report 9204104 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT WAS REVISED FOR PAINFUL TOTAL KNEE AND LIMITED RANGE OF MOTION. COMPONENTS WERE FOUND TO BE WELL FIXED. PARTS WERE REMOVED IN FAVOR OF A REVISION KNEE. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Muscular Rigidity; No Code Available; Not Applicable; Pain

  MAUDE report 7408048 ↗
• InjuryApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED MEDICAL RECORDS (B)(6) 2018. UPON REVIEW OF THE MEDICAL RECORDS, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015. THERE WAS AN ESTIMATED BLOOD LOSS OF 800ML, BUT THE SURGEON REPORTED NO COMPLICATIONS AND THERE WAS NO UNITS OF BLOOD ORDERED. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND RETURNED 2 DAYS LATER WITH A PE IN THE LEFT LOWER LOBE SEGMENT PULMONARY ARTERY. POST OPERATIVE MEDICAL RECORDS NOTED THAT THE PATIENT REPORTED PAIN.

  Patient problems: Blood Loss; Joint Disorder; No Code Available; Pain; Pulmonary Embolism

  MAUDE report 7395825 ↗
• InjuryJan 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE IMPLANTS WERE REMOVED DUE TO INFECTION, PLEASE SEE REFERENCE AND LOT NUMBERS OF IMPLANTS BELOW, ATTUNE FEMUR SIZE 7 RIGHT REF: 150400207 LOT: 8088260-02. ATTUNE TIBIA SIZE 6 REF: 150600008 LOT: 8331994. ATTUNE FB INSERT SIZE 8MM X 7 REF: 151620708 LOT: 647466.

  Patient problems: Unspecified Infection

  MAUDE report 7177926 ↗
• InjuryOct 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. WASH OUT AND POLY EXCHANGE WAS DONE.

  Patient problems: Unspecified Infection

  MAUDE report 6948827 ↗