ATTUNE 1516-40-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10603295050209), received between Nov 4, 2017 and Sep 29, 2026 — classified as 96 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 106 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fracture; Naturally Worn

  Patient problems: Joint Laxity

  MAUDE report 50930166 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that early infection of left knee. DAIR performed.Affected Side: Left Knee

  Patient problems: Unspecified Infection

  MAUDE report 50088839 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25750418 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON NEEDED TO SWAP THE POLY. DOI: UNKNOWN DOR: (B)(6) 2026 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25459035 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY DUE TO IMPLANT. ORIGINAL IMPLANT DATE UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24649532 ↗
• MalfunctionMar 10, 2026Difficult to Insert

  IT WAS REPORTED THAT ATTUNE PS FB INSRT SZ 7 5MM WAS NOT FIRMLY IMPLANTED IN THE TIBIAL PLATE DURING AN INTRAOPERATIVE PROCEDURE, REQUIRING THE SURGEON TO USE ANOTHER UNIT OF THE SAME PRODUCT. THERE WAS NO REPORTED HARM TO THE PATIENT OR USER, AND NO SIGNIFICANT DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559834 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WOUND DRAINING. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 24535301 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY WITH DOWNSIZING OF THE FEMUR COMPONENT AND REVISION OF THE TIBIAL INSERT AND PATELLA COMPONENTS. THE PATIENT DEVELOPED ARTHROFIBROSIS, RESULTING IN KNEE STIFFNESS AND IMPAIRED JOINT MOVEMENT, WHICH LED TO AN INABILITY TO ADEQUATELY EXTEND OR FLEX THE KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE-UNKNOWN KNEE.

  Patient problems: Arthrofibrosis; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 24507008 ↗
• MalfunctionJan 16, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE DEVICES WERE RECEIVED DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097919 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION CONTRACTURE. NO OTHER INFORMATION WAS KNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Septic loosening

  MAUDE report 23841806 ↗
• MalfunctionDec 16, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN IMPACTING POLYETHYLENE, THE DEVICE DID NOT HOLD AND DISLOCATED AS SOON AS THE KNEE WAS EXTENDED. AFTER MORE THAN 45 MINUTES OF ATTEMPTS, THE SURGEON DECIDED TO TAKE ANOTHER INSERT OF THE SAME SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820941 ↗
• InjuryDec 5, 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: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23729679 ↗
• InjuryDec 5, 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 MID-FLEXION INSTABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23729328 ↗
• InjuryDec 5, 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 MID-FLEXION INSTABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23729327 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTED TOTAL KNEE. PATIENT UNDERWENT I&D WITH INSERT EXCHANGE. DURING SURGERY, THE TIBIAL INSERT WAS REMOVED, JOINT WAS DEBRIDED & IRRIGATED, & A NEW INSERT IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23426464 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR POLY SWAP DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22883369 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DAIR. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22677828 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REPORTEDLY UNHAPPY WITH STABILITY. REVISION WAS PERFORMED. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22642123 ↗
• MalfunctionJul 3, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS NOT POSSIBLE TO ENGAGE THE INLAY WITH THE TIBIAL TRAY. ANOTHER INLAY WAS AVAILABLE AND USED WITHOUT ANY ISSUE. THERE WAS FIVE MINUTES OF SURGICAL DELAY; NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395449 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6), 2024. DOR: (B)(6), 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22382449 ↗
• MalfunctionJun 16, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE TIBIAL IMPLANT DID NOT SIT CORRECTLY. KNEE WAS UNSTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213813 ↗
• MalfunctionJun 2, 2025Difficult to Insert; Difficult to Insert

  INTRA-OPERATIVE ISSUE WITH THE IMPLANT; TIBIAL INSERT DID NOT FIT ONTO THE TIBIA AND APPEARED DIFFERENT TO STANDARD IMPLANT SUGGESTING MANUFACTURING DEFECT. ANOTHER IMPLANT WAS USED INSTEAD SUCCESSFULLY. THERE WERE NO COMPLICATIONS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125565 ↗
• MalfunctionJun 2, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS AN INTRA-OPERATIVE ISSUE WITH THE IMPLANT. THE TIBIAL INSERT DID NOT FIT ONTO THE TIBIA AND APPEARED DIFFERENT TO STANDARD IMPLANT. ANOTHER IMPLANT WAS USED INSTEAD SUCCESSFULLY. THERE WERE NO COMPLICATIONS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122491 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POLY SWAP DUE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22046619 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. AFFECTED SIDE: UNKNOWN .

  Patient problems: Pain

  MAUDE report 21577122 ↗

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