ATTUNE 1516-40-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295049951), received between Aug 3, 2017 and Jun 12, 2026 — classified as 55 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEEDED BIGGER POLY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25491123 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DID NOT GO TO PHYSICAL THERAPY, SO THEY STIFFENED UP AND DEVELOPED A CONTRACTURE. SURGEON PERFORMED AN ARTHROTOMY AND DOWNSIZED THE POLY TO RE-ESTABLISH FULL EXTENSION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Septic loosening

  MAUDE report 24651529 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ATTUNE PRIMARY WAS PUT IN A VALGUS KNEE. TRACKING WELL ON TABLE BUT SUBLUXES WHEN PATIENT FLEXES. LATERAL SIDE AND PATELLA FINE, MEDIAL SIDE - TIBIA MOVES ANTERIOR, FEMUR POSTERIOR. BEARING LOOKS SEATED ON XR, SIZES APPROPRIATE, NO LOOSE BODIES SEEN. IF WENT TO REVISION COULD I USE MEDIAL PIVOT BEARING IN THE PRIMARY TIBIA WITH PS FEMUR. ELDERLY LOW DEMAND PATIENT. NO REVISION SURGERY PLANNED.

  Patient problems: Joint Laxity

  MAUDE report 24443040 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24006110 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT OVER TIME, THE PATIENT'S KNEE BECAME PAINFUL AND TIBIA APPEARS TO HAVE SUBSIDED MILDLY. REVISION SURGERY WAS PERFORMED ON THE TIBIA, POLY, AND PATELLA, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23831685 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S PRIMARY ATTUNE 8MM TIBIAL INSERT WAS REMOVED AND REPLACED BY A THICKER 14MM TIBIAL INSERT. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23810611 ↗
• InjuryAug 6, 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 INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22727870 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22028107 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024 , DOR: (B)(6) 2024 , AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20097264 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE KNEE WAS REVISED DUE TO LOOSE FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280833 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2024. (LEFT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 19041952 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WEAS REPORTED THAT PATIENT FELL A WEEK AGO. KNEE IS INFECTED NOW. DOC TOOK THE POLY OUT AND WASHED OUT THE KNEE THEN REPLACED WITH THE SAME SIZE POLY. DOI- (B)(6) 2016. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 18920514 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY SWAP IN TKA FOR INSTABILITY. THICKER INSERT PLACED. AN 8MM INSERT WAS REMOVED AND A 12MM INSERT WAS PLACED.

  Patient problems: Joint Laxity

  MAUDE report 18721951 ↗
• InjuryFeb 13, 2024Adverse 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 45 DEGREE FLEXION CONTRACTURE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT.

  Patient problems: Joint Contracture

  MAUDE report 18697563 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL - CREATED INSTABILITY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 18450897 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17845032 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. POLY EXCHANGE WAS PERFORMED. DOI: (B)(6), 2021; DOR: (B)(6), 2023; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17844648 ↗
• MalfunctionJul 18, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE HOSPITAL IMPLANTED A PRODUCT WITH AN EXPIRATION DATE OF (B)(6)2023.

  Patient problems: Insufficient Information

  MAUDE report 17341169 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16993529 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SPLIT OPEN HER INCISION SITE. THE IRRIGATION AND DEBRIDEMENT WAS PERFORMED ALONG WITH A POLY EXCHANGE. UNKNOWN SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2023, DOR:(B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 16712867 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED AN ATTUNE CR PS SIZE 5 8MM POLY DUE TO PATIENT HAVING ANTERIOR KNEE PAIN IMPLANTED A 12MM POLY IN PLACE DOI: (B)(6) 2019. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15378712 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS POLY EXCHANGE DUE TO INSTABILITY. NO ADDITIONAL INFORMATION. THERE WAS NO SURGICAL DELAY. DOI-(B)(6) 2021. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15163443 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON NOTICED REDNESS AROUND THE INCISION AND WANTED TO PERFORM AN IRRIGATION AND DEBRIDEMENT. UPON OPENING, THE SURGEON WENT AHEAD AND CHANGED OUT THE POLY. THERE WAS NO SURGICAL DELAY. DOI: NOT INDICATED. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Erythema

  MAUDE report 14787577 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I & D OF LEFT HIP AND LYSIS OF ADHESIONS. POLY INSERT SWAP. DOI: UNKNOWN. DOR: (B)(6), 2022. LEFT HIP.

  Patient problems: Adhesion(s); Osteolysis

  MAUDE report 14433855 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. PATIENT HAD TWO PREVIOUS I&D AND INSERT EXCHANGES OVER THE PAST SIX MONTHS. ATTUNE PS FIXED BEARING KNEE REMOVED. SURGEON IMPLANTED A CR SIGMA FEMORAL AND ALL-POLY TIBIA, CEMENTED IN WITH ANTIBIOTIC CEMENT AS A SPACER. DOI: 2019. DOR: (B)(6), 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13789977 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507