ATTUNE 1516-40-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10603295049784), received between Oct 13, 2017 and Apr 16, 2026 — classified as 56 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A THICKER POLY DUE TO LAXITY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24896376 ↗
• MalfunctionApr 13, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, THE DEVICE CANNOT MATCH THE PLATFORM. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24862095 ↗
• MalfunctionNov 19, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, THE IMPLANT COULD NOT IMPLANTED INTO THE TIBIAL PLATEAU. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594995 ↗
• MalfunctionNov 19, 2025Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PS POLY WAS DAMAGED DURING INSERTION. THE LOCKING CLIP BENT IN THE WRONG DIRECTION DURING IMPACTION WHICH MEANT IT COULDN'T BE USED. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. USED A LARGER THICKNESS POLY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594122 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TOTAL KNEE ARTHROPLASTY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23526667 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D WASH OUT TO PREVENT INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23513786 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN ORGAN TRANSPLANT AND THIS CAUSED AN INFECTION OF THEIR TOTAL KNEE. KNEE WAS WASHED OUT, TEMPORARY ANTIBIOTIC LOADED CEMENT BEADS WERE PLACED AND LINER EXCHANGED. NO MORE INFORMATION IS KNOWN. NO DELAYS. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23452499 ↗
• MalfunctionJun 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE IMPLANT WAS NOT ABLE TO BE PLACED AND SECURED ON THE TIBIAL COMPONENT. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327182 ↗
• MalfunctionJun 2, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PATIENT UNDERWENT KNEE SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE GASKET COULD NOT BE INSTALLED PROPERLY ON THE PLATFORM. SURGEON COULD NOT LOCK THE INSERT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126215 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP FOR DEBRIDEMENT. THERE WAS NO LOOSENING AND NO IMPLANT FAILURE. ALL PIECES RETRIEVED. IMPLANTED AT O INSTITUTE. NO ADVERSE REACTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21746835 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT 3 RIGHT KNEE REPLACEMENTS. THEY UNDERWENT A RIGHT KNEE ARTHROPLASTY IN 2021. THEY THEN UNDERWENT REVISION IN 2022 TO ADDRESS STIFFNESS, LIMITED MOBILITY, PAIN, AND SWELLING. THEY THEN UNDERWENT ANOTHER REVISION IN 2022 TO ADDRESS THE SAME CONCERNS. AFTER THIS REVISION, THE PATIENT CONTINUED TO HAVE PAIN, SWELLING, AND DIFFICULTY WITH AMBULATION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 21266001 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD 3 RIGHT KNEE REPLACEMENTS, FIRST ONE IN 2021 AND MOST RECENT ONE BEING 2022. THE PATIENT STATED AFTER EACH KNEE REPLACEMENT SHE EXPERIENCED RIGHT LEG SWELLING AND PAIN.

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 21229420 ↗
• MalfunctionAug 21, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO HARM TO THE PATIENT AND ONLY A SLIGHT DELAY IN GETTING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011949 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP AND WASH OUT WAS PERFORMED DUE TO POTENTIAL INFECTION. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19949481 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA FOR THE KNEE JOINT WITH THE INSERT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2024, DUE TO INFECTION, THE AFFECTED AREA IS SCHEDULED TO BE CLEANED AND THE INSERT REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 19773613 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19472114 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE FIRST DAY AFTER SURGERY, A FOLLOW-UP ULTRASOUND WAS PERFORMED ON THE RIGHT LOWER LIMB BLOOD VESSELS, AND THE RESULTS SHOWED PARTIAL INTRAMUSCULAR VEIN THROMBOSIS AND POSTERIOR TIBIAL VEIN THROMBOSIS IN THE RIGHT LOWER LIMB.

  Patient problems: Loss of Range of Motion; Thrombosis/Thrombus

  MAUDE report 18314752 ↗
• MalfunctionNov 29, 2023Difficult to Insert; Difficult to Insert

  BEFORE POSITIONING THE ATTUNE FB 4*5 MM TIBIAL INSERT, WHICH ENTERS CORRECTLY INTO THE PLATE BUT DOES NOT ANCHOR, PRESENTING MOVEMENTS AND DISLOCATION TO THE TIBIAL TRAY. IF IT IS IMPOSSIBLE TO CHANGE THE TIBIAL PLATEAU, IT IS DETERMINED TO CHANGE THE INSERT AND EVALUATE ITS FIXATION. THE MOS WAREHOUSE IS INFORMED TO REQUEST THE PROCESS TO FOLLOW AND COMMUNICATION IS ACHIEVED WITH THE LINE VISITOR. THE NEW INSERT IS POSITIONED IN THE TIBIAL TRAY WITHOUT ANY INCONVENIENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226346 ↗
• MalfunctionSep 28, 2023Improper or Incorrect Procedure or Method; Expiration Date Error; Improper or Incorrect Procedure or Method; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED IMPLANT HAS BEEN IMPLANTED-EXPIRED DATE (B)(6) 2023 LEFT TOTAL KNEE PROSTHESIS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/OUTCOME/ CONSEQUENCES, NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY NO. (B)(4). DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835791 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGERY WAS PERFORMED WITH THE IMPLANT IN QUESTION. AFTER THE SURGERY, INFECTION WAS CONFIRMED ON AN UNKNOWN DATE. THE PATIENT WILL BE TREATED BY THE DEBRIDEMENT ON (B)(6) 2023. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17298520 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FALL POST OP DAY 1. RUPTURE ARTHROTOMY. DOI: (B)(6) 2023. DOR:(B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 17236981 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE KIDNEY INJURY AND DEHYDRATION (HYPOVOLEMIA) EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022, (RIGHT KNEE). TREATMENT: PRESCRIBED PANTOPRAZOLE & GIVEN IV HYDRATION.

  Patient problems: Dehydration; Renal Impairment

  MAUDE report 16832987 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. DOI: (B)(6), DOR: (B)(6), AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16732350 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFF KNEE. I&D, POLY AND PATELLA EXCHANGE WERE DONE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 16544818 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. IMPLANTS WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16494756 ↗

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