ATTUNE 1518-20-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295541752), received between Feb 13, 2023 and Sep 28, 2026 — classified as 19 injuries.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to infection. All implants were explanted, irrigation and antibiotics were used and a spacer was put in place. Nothing further to report. Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50915449 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR DEBRIDEMENT OF SCAR TISSUE AND LINER EXCHANGE. NO LOOSENING, NO ISSUE WITH IMPLANTS REPORTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 25596863 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALLING AFTER TOTAL KNEE REPLACEMENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 25349186 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I&D OF THE LEFT KNEE WITH A POLY SWAP WAS PERFORMED. DOI- (B)(6) 2026. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24730499 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SOFT TISSUE HAD STRETCHED OUT, RESULTING IN INSTABILITY. DOI- (B)(6) 2024. DOR- (B)(6) 2026. AFFECTED SIDE-UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24648443 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POTENTIAL INFECTION. ATTUNE 6MONTH.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24549775 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT KNEE STARTED TO HYPER EXTEND. REMOVED 6X8 MS INSERT AND PLACED A 6X10 MS INSERT. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24445260 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT NEEDED THICKER POLY FOR A MORE STABLE CONSTRUCT. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24428496 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD FLEXION CONTRACTURE. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Septic loosening

  MAUDE report 24222327 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMES BACK TODAY FOR A POLY SWAP/IRRIGATION AND DEBRIDEMENT OF A TOTAL KNEE FOR SUSPECTED INFECTION. SHE WAS PREVIOUSLY WASHED OUT ON (B)(6) OF THIS YEAR. THE DOCTOR REMOVED THE POLY INSERT, WASHED THE JOINT OUT THOROUGHLY AND REPLACED THE POLY INSERT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23759447 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PREVIOUS LEFT TOTAL KNEE DONE BY DR. (B)(6) WITH ATTUNE CR FB MEDIAL STABILIZED KNEE. SHE ENDED UP GETTING A PATELLA TENDON RUPTURE AND WAS BRING FOR REVISION. THE MS LEFT 6X8MM INSERT WAS REMOVED AND A NEW MS LEFT 6X6MM WAS IMPLANTED. THE 35M PATELLA COMPONENT ALONG WITH THE WHOLE PATELLA WERE EXCISED. NO COMPLICATIONS OR DELAY IN SURGERY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23757393 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS EXCHANGED DUE TO INSTABILITY, INCREASED BY 2MM. ALL PIECES WERE REMOVED, NO HARM WAS DONE TO THE PATIENT AND THERE WAS NO DELAY TO THE CASE. NO FURTHER INFORMATION ON THIS OPERATION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23583804 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND WASHING OUT WITH POLY EXCHANGE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21890930 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL ON THE SAME DAY AS SURGERY, OPENED WOUND AND CAPSULE HAD A WASH OUT AND POLY WAS SWAPPED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 20675087 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20506211 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS DRAINING A COUPLE WEEKS OUT FROM SURGERY, SURGEON FOUND IT BEST TO IRRIGATE THE KNEE, SWAP THE POLY AND ADD STIMULANT BEADS TO THE JOINT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19938599 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 18357592 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION SO SURGEON WASHED THE JOINT OUT AND CHANGED THE POLY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17197486 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND OPENED HER INCISION FROM PRIOR KNEE REPLACEMENT. POLY WAS EXCHANGED AND KNEE WAS WASHED OUT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 16363883 ↗