ATTUNE 1511-11-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295436591), received between Dec 12, 2019 and Aug 7, 2025 — classified as 7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POSTOPERATIVELY AND FRACTURED AROUND AND DISTAL TO THE TIBIAL COMPONENT. IMPLANTS WERE REMOVED IN AN EFFORT TO BYPASS THE FRACTURE SITE AND ACHIEVE STABLE FIXATION MORE DISTAL IN THE TIBIA. ALL COMPONENTS HAD PERFORMED AS EXPECTED AND NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. MODULAR FEMORAL COMPONENTS WERE REMOVED TO GAIN EXPOSURE AND WERE EXCHANGED AS THE PATIENT HAD A PRIOR HISTORY OF INFECTION. RESORBABLE ANTIBIOTIC BEADS WERE PLACED AS A PRECAUTION ALTHOUGH EVIDENCE OF PERSISTENT INFECTION WAS NOT PRESENT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22740866 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DSJ-2016-02 CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA TENDON RUPTURE AND INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019 DATE OF EVENT: (B)(6) 2024 (RIGHT KNEE). TREATMENT: RECONSTRUCTION OF PATELLA TENDON, I&D, INJECTED MEDICATION, AND REPEATED DAIR PROCEDURES.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19126144 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR FLEXION DEFICIT AT RIGHT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019; DATE OF EVENT: (B)(6) 2023; (RIGHT KNEE). TREATMENT: DIAGNOSTIC INTERVENTION AND RESECTION OF HETEROTOPIC BONE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19117313 ↗
• InjuryApr 8, 2024Adverse 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 PAIN. THERE WAS NO DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19058639 ↗
• InjuryAug 23, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE SLEEVE AND THE IMPLANTS NEEDED TO BE REVISED TO LPS. THE LOOSENING INTERFACE WAS UNKNOWN AND CEMENT MANUFACTURER WAS UNKNOWN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17603663 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020; DATE OF EVENT (ONSET): (B)(6) 2020; (LEFT KNEE). TREATMENT: 2 X ERYTHROCYTE CONCENTRATE (TRANSFUSION 2 UNITS PACKED RED BLOOD CELLS).

  Patient problems: Anemia

  MAUDE report 11263892 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL DATABASE INFORMATION RECEIVED. PATIENT REPORTS PAIN, PROBLEMS WALKING AND DOING USUAL ACTIVITIES AND DISCOMFORT.

  Patient problems: Ambulation or Postural Difficulties; Anemia; Discomfort; Pain

  MAUDE report 9457285 ↗