ATTUNE 1518-20-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295541813), received between Mar 19, 2022 and Jun 9, 2026 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT COMPLAINED OF INSTABILITY AND PAIN. THE SURGEON HAS NO CONCERNS ABOUT X-RAYS BUT HAS AGREED TO EXCISE ANY SCAR TISSUE AND UPSIZE THE POLY TO INCREASE STABILITY. THAT IS EXACTLY WHAT HE DID. INCREASED POLY FROM 6MM TO 7MM. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 25446534 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE POLY EXCHANGE WASHOUT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24148681 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED LEFT TOTAL KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24132214 ↗
• InjurySep 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A DAIR REQUIRING NEW IMPLANTS DUE TO INFECTION AND DISLOCATION OF MS FB POLY. THE SURGEON CONFIRMED THE PATIENT HAS HAD AN INFECTION FOR SEVERAL WEEKS, AND ABOUT FOUR (4) WEEKS AGO HAD A FIRST DAIR WHICH RESULTED IN A SWAPPED OUT POLY TO INITIALLY TREAT. SINCE THEN THE PATIENT HAD A FALL AND THE INFECTION HAS NOT CLEARED. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY DUE TO THE POLY DISLOCATION. THE SURGEON FELT LIKE NOT WASHING OUT FOR THE INFECTION MAY HAVE RESULTED IN THE POLY NOT SEATING CORRECTLY INITIALLY.

  Patient problems: Fall; Joint Dislocation; Unspecified Infection

  MAUDE report 23110544 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ORIGINAL TKR WAS A CR ATTUNE IMPLANTED IN 2018. POSTOPERATIVELY, THE PATIENT HAD A LONG SLOW RECOVERY REQUIRING AN MUA TO HELP RANGE. A REVISION WAS PERFORMED IN (B)(6) 2025 WITH A NEW MS POLY REPLACING THE ORIGINAL CR POLY AND PATELLA RESURFACING. A MUA WAS DONE FOR STIFFNESS AT 8 WEEKS POST OPERATIVELY. THERE IS NO PROBLEM WITH THE MS INSERT. THE PATIENT WAS REPORTING IMPROVED STABILITY AND FUNCTION POST REVISION.

  Patient problems: Muscular Rigidity

  MAUDE report 22213876 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A SEVERE FALL AND HAD KNEE PAIN DUE TO INJURY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 21633650 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE HAVE BEEN 3 REVISIONS IN THE ATTUNE MS COHORT. 1 EACH FOR INFECTION, INSTABILITY, AND ASEPTIC MECHANICAL LOOSENING. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 21314107 ↗
• InjuryJan 22, 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 INFECTION OF KNEE. INSERT WAS SWAPPED AND KNEE WASHED OUT. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21211438 ↗
• InjuryJan 9, 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 KNEE INFECTION. THE KNEE WAS WASHED OUT AND POLY SWAPPED. NO DELAY IN SURGERY WAS REPORTED. DOI: (B)(6) 2024 , DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21111642 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FALLEN AND OPENED HIS WOUND DOWN TO THE IMPLANTS POST OP. LIGAMENTS WERE LOOSER, SO POLY NEEDED TO BE UPSIZED. THERE WAS NO LOOSENING. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Wound Dehiscence

  MAUDE report 20461351 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO BILATERAL KNEE INFECTION. SURGEON REPLACED POLY IN BOTH KNEES. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE. (B)(4) CAPTURE LEFT KNEE (B)(4) CAPTURE RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19382567 ↗
• MalfunctionMar 28, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT MS POLY INSERT WOULD NOT LOCK. ATTEMPTED THREE TIMES AND IT RELEASED EACH ATTEMPT. THEY TRIED ANOTHER POLY AND IT SEATED PERFECTLY IN THE FIRST ATTEMPT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992503 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT (I&D) WASHOUT AND LINER CHANGE TO RULE OUT INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18650023 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18184027 ↗
• MalfunctionJan 27, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE MS TIBIAL INSERT DID NOT SEAT DOWN ALL THE WAY AFTER IMPACTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253328 ↗
• InjurySep 24, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL KNEE DONE WITH MEDIAL STABILIZED INSERT, HOWEVER, A LEFT INSERT WAS OPENED AND IMPLANTED IN THE PATIENT. THE PATIENT HAD TO GO BACK TO THE OR TO HAVE THE LEFT INSERT TAKEN OUT AND THE RIGHT INSERT PUT IN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15481522 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE ARTHROPLASTY - SEROMA. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: IRRIGATION AND DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 13824322 ↗