ATTUNE 1516-40-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295049838), received between Nov 20, 2018 and Apr 14, 2026 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LAXITY; NEEDED THICKER POLY. IT WAS A KNEE, NO HEAD AND CUP. FEMUR AND TIBIA WAS SOLID. DOI: 2016. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 24876654 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHTNESS. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 12803670 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11393389 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 26 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS AND CAPSULAR HERNIA. THE SURGEON REPORTED A HERNIATION IN THE LATERAL CAPSULE AROUND THE PATELLA WHICH WAS THEN REPAIRED. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR¿S BONE CEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO MECHANISM DYSFUNCTION AND INTERNAL DERANGEMENT. THE SURGEON OFFERED NO CONCERNS WITH ANY OF THE IMPLANTED COMPONENTS, THOUGH ALL WERE REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2018; (LT KNEE).

  Patient problems: No Code Available

  MAUDE report 9210860 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8091206 ↗

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