ATTUNE 1518-20-605Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295541721), received between May 21, 2024 and Sep 18, 2026 — classified as 13 injuries, 3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50822825 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient fell 2 weeks post op and needed a poly swap.Affected side-Left knee.

  Patient problems: Fall

  MAUDE report 50299257 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient's knee was revised due to infection. Knee was washed out and liner was exchanged. Antibiotics placed for a 2 stage wash out. There was no patient injury or delay.DOI: (b)(6) 2026.DOR: (b)(6), 2026.Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50073182 ↗
• MalfunctionJul 17, 2026Difficult to Insert; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25855777 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  "ADDITIONAL INFORMATION RECEIVED" A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -NO ADVERSE CONSEQUENCES OTHER THAN PATIENT WAS BEING REVISED BECAUSE SHE FELT LOSE. B. WHAT WAS THE REASON FOR REVISION? PATIENT WAS LOSE AND WANTED MORE STABILITY.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 24430819 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP WAS DONE DUE TO A FALL. IT DID NOT COME LOOSE. THERE WAS NO FURTHER INFORMATION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 24420310 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND SURGEON SUSPICION OF INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 24221366 ↗
• MalfunctionDec 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) WITH A CRUCIATE-RETAINING FEMORAL MULTI-SIZE POLYETHYLENE, THE SURGEON IMPACTED THE POLYETHYLENE INSERT AND FELT THE LOCKING MECHANISM DID NOT ENGAGE CORRECTLY. THE SURGEON REMOVED AND REINSERTED THE INSERT SEVERAL TIMES AND OPENED A SECOND AND THEN A THIRD POLYETHYLENE WITH THE SAME ISSUE. AFTER A FOURTH POLYETHYLENE WAS OPENED AND STILL DID NOT SATISFY THE SURGEON, A STEMMED TIBIAL COMPONENT WAS OPENED IN CASE TRAY REMOVAL WAS REQUIRED AND TO EVALUATE WHETHER THE TIBIAL TRAY MIGHT BE CAUSING THE LOCKING FAILURE; THE TEAM ATTEMPTED TO ENGAGE THE POLYETHYLENE AND TRAY ON THE BACK TABLE. THE SURGEON WAS NOT CONVINCED THAT CHANGING TRAYS WOULD RESOLVE THE PROBLEM AND ULTIMATELY IMPLANTED A 6X7 LEFT MULTI-SIZE POLYETHYLENE, ALTHOUGH THE SURGEON REMAINED NOT FULLY SATISFIED AT THE CONCLUSION OF THE CASE. NO FURTHER INFORMATION IS AVAILABLE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830301 ↗
• MalfunctionDec 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) WITH A CRUCIATE-RETAINING FEMORAL MULTI-SIZE POLYETHYLENE, THE SURGEON IMPACTED THE POLYETHYLENE INSERT AND FELT THE LOCKING MECHANISM DID NOT ENGAGE CORRECTLY. THE SURGEON REMOVED AND REINSERTED THE INSERT SEVERAL TIMES AND OPENED A SECOND AND THEN A THIRD POLYETHYLENE WITH THE SAME ISSUE. AFTER A FOURTH POLYETHYLENE WAS OPENED AND STILL DID NOT SATISFY THE SURGEON, A STEMMED TIBIAL COMPONENT WAS OPENED IN CASE TRAY REMOVAL WAS REQUIRED AND TO EVALUATE WHETHER THE TIBIAL TRAY MIGHT BE CAUSING THE LOCKING FAILURE; THE TEAM ATTEMPTED TO ENGAGE THE POLYETHYLENE AND TRAY ON THE BACK TABLE. THE SURGEON WAS NOT CONVINCED THAT CHANGING TRAYS WOULD RESOLVE THE PROBLEM AND ULTIMATELY IMPLANTED A 6X7 LEFT MULTI-SIZE POLYETHYLENE, ALTHOUGH THE SURGEON REMAINED NOT FULLY SATISFIED AT THE CONCLUSION OF THE CASE. NO FURTHER INFORMATION IS AVAILABLE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830229 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PRIOR TOTAL KNEE ARTHROPLASTY ON THE LEFT KNEE DONE AT THE HOSPITAL. PATIENT FELL AND OPENED HER INCISION. THE WOUND WAS IRRIGATED, AND THE POLY WAS REMOVED AND REPLACED WITH A NEW POLY OF THE SAME SIZE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 23415394 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED PRIMARY KNEE AND SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH FUNCTIONAL SPACER. THERE WERE NO COMPLAINTS OR DELAYS. IMPLANTS WERE NOT BEING RETURNED. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22140733 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I & D WASHOUT WITH POLY SWAP. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21549630 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A DIFFICULT TIME GETTING FLEXION. THERE WAS CONCERN THAT THE FEMUR MAY BE LOOSE. REVISION WAS PERFORMED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21527257 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL A FEW DAYS AFTER SURGERY AND TORE THEIR STITCHES OPEN. THE SURGEON WASHED OUT THE KNEE AND CHANGED THE LINER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 21136818 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 20321212 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND WASHOUT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19360859 ↗