ATTUNE 1517-10-808Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295056249), received between May 9, 2019 and Jan 26, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI (B)(6) 2023. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24180374 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22375937 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INFECTION IN KNEE AND WAS REVISED DUE TO THAT. THE SURGEON REMOVED ALL COMPONENTS AND PLACED ABX SPACER. NO SURGICAL DELAY. DOI: 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22026354 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY: DSJ-2016-02. CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019 DATE OF EVENT (ONSET): 07/03/2020 (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT, WITH REVISION OF TIBIAL INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 20032768 ↗
• InjuryJan 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED CRS TOTAL KNEE ARTHROPLASTY AND TRIED TO CLOSE REDUCE. SURGEON OPENED JOINT, REDUCED THEN DECIDED TO UPSIZE POLY THICKNESS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 18444078 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN ATTUNE CRS IMPLANTED. THIS WAS A REVISION FOR A FAILED TRIATHLON TKR. THE PATIENT HAS BEEN HAPPY WITH HIS ATTUNE CRS, BUT WAS KICKED BY A COW OVER THE WEEKEND WHILST PERFORMING CHORES ON HIS FARM. THE KNEE SWELLED AND THE SKIN STARTED TO TURN BRIGHT RED IN COLOR. THE PATIENT PRESENTED TO THE HOSPITAL AND UNDERWENT TESTING, AND IT WAS DECIDED THAT THE KNEE WOULD BE OPENED, A SYNOVECTOMY PERFORMED, AND A NEW ATTUNE CRS INSERT PUT IN. DOI: (B)(6) 2022. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Erythema; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17404512 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6), DOR: (B)(6), AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16732428 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN ATTUNE REVISION WHICH WAS DONE ON 23/08 AT WAKEFIELD. THE REASON FOR THE REVISION TODAY WAS DUE TO INFECTION. THE POLY INSERT WAS REMOVED AND A WASHOUT WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 15494286 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SWELLING AROUND THE KNEE JOINT BUT NOT MUCH PAIN. THE SURGEON IRRIGATED AND DEBRIDED THE KNEE, CHANGED POLY AND ADMINISTERED ANTIBIOTICS TO JOINT. TOOK SOME TISSUE SPECIMEN TO BE SCREENED. UNAWARE OF RESULTS. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2021; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15321132 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12819499 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE LEFT KNEE.

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

  MAUDE report 10918909 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE HAVE TODAY EXTRACTED AN ATTUNE REVISION CONSTRUCT, DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9505242 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENTS LEFT KNEE WAS REVISED WITH AN I & D AND POLY EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT KNEE

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9071440 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE BECAME REINFECTED. DOI: (B)(6) 2019, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8971949 ↗
• InjuryMay 9, 2019Unintended Movement; Unintended Movement

  PATIENT WAS REVISED TO ADDRESS DISLOCATED POLY. NOTED THAT REDUCTION OF THE POLY WAS DIFFICULT. DOI: (B)(6) 2019, DOR: (B)(6) 2019 RIGHT KNEE. AS PER SALES REP, THE POLY ROTATED MORE THAN 90 DEGREES BUT DID NOT COME OFF FROM THE TRAY.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8594874 ↗