ATTUNE 1516-40-908Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295050513), received between Feb 14, 2020 and Jul 17, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION FOR DISCOMFORT; POLY WAS SWAPPED; 9X8MM FB PS ATTUNE POLY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 25855412 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LAXITY. DOCTOR INCREASED POLY FROM 8MM TO 14MM IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 21217896 ↗
• InjuryOct 31, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CRACKED AND WORN POLY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20578499 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENTS WAS REVISED FOR INSTABILITY DUE TO A FALL. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 18063882 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS TO ER WITH A WARM SWOLLEN KNEE ROUGHLY 3 MONTHS AFTER LTKA. PATIENT WAS DOING WELL WITH NO ISSUES PRIOR. PATIENT BROUGHT TO OR AND A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED TO INCLUDE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND INSERT. NO PATIENT HARM OCCURRED. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 17540114 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D POLY EXCHANGE DUE TO INFECTION. NO ADDITIONAL INFORMATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16458906 ↗
• InjuryDec 18, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAS LARGE VOIDS IN BOTH THE FEMUR AND TIBIA. THE SURGEON IS SUSPICIOUS OF OSTEOLYSIS. POLY LOOKS LIKE OXIDATION HAS TAKEN EFFECT, PIMPLES AND DIVOTS EVERYWHERE IN POLY. SURGEON IS REQUESTING RESPONSE AND REVIEW. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Osteolysis

  MAUDE report 11038657 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9781857 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9711721 ↗

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