ATTUNE 1504-01-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295041429), received between Nov 6, 2020 and Aug 12, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

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

  Subject ID: (b)(4).Study No: (b)(6). Clinical Adverse Event received for Revision ¿ Pain/Stiffness. Device Related: No Information Provided.Procedure Related: No Information Provided.Date of Event: (b)(6) 2026. Date of Implant: No Information Provided.Date of Revision: (b)(6) 2026. Device Location: No Information Provided. Treatment/Impact: Revision, DePuy Synthes components removed (Femoral : YES, Insert : YES). DePuy Synthes Products Used: Date of Implant: (b)(6) 2025.Device location: left.Catalog number: 150401125.Lot number ID: No Information Provided.Component type: FEMORAL.Description: Attune Knee System FEMORAL POROCOAT CRUCIATE RETAINING NARROW SIZE 5N LEFT CEMENTLESS.Catalog number: 151820506.Lot number ID: M97P28.Component type: INSERT.Description: ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED LEFT AOX 5, 6mm.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50224519 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS PAIN AND TIGHTNESS IN THE KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24815512 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO. C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. D. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO. E. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO.

  Patient problems: Joint Laxity

  MAUDE report 20311716 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TOTAL KNEE WAS REVISED DUE TO COMPLAINING OF PAIN. DOI: (B)(6) 2023 , DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 19381168 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR PERFORMED A REVISION TOTAL KNEE ON PATIENT COMPLAINING OF PAIN. (B)(6) 2022, (B)(6) 2023, UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 16822715 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK WITH A NICKEL ALLERGY. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11506651 ↗
• InjuryMar 5, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT INFECTION IS THE REASON FOR LOOSENING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration

  MAUDE report 11418953 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S KNEE WAS REVISED DUE TO TIGHT IN EXTENSION. DOI: (B)(6) 2020 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10801453 ↗