ATTUNE 1547-08-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295382867), received between Dec 11, 2019 and Aug 14, 2026 — classified as 19 injuries.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Unspecified Infection

  MAUDE report 50260196 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION PROCEDURE DUE TO PERSISTENT INFECTION FOLLOWING A PREVIOUS TWO-STAGE REVISION. ALL COMPONENTS WERE EXPLANTED AND DISCARDED, AND THEY WERE REPORTED TO BE WELL FIXED AT THE TIME OF REMOVAL. THE PATIENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE DEVICES WERE REPLACED OR REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 25552401 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISTAL FEMORAL FRACTURE. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 22967141 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISTAL FEMORAL FRACTURE. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 22967119 ↗
• InjuryApr 17, 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 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 19126167 ↗
• 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 19126158 ↗
• 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 19117299 ↗
• 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)(4). 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: ON (B)(6) 2019, DATE OF EVENT: UNK NOV 2023, (RIGHT KNEE). TREATMENT: DIAGNOSTIC INTERVENTION AND RESECTION OF HETEROTOPIC BONE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19117294 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PROSTHETIC INFECTION WAS REPORTED,

  Patient problems: Unspecified Infection

  MAUDE report 18929535 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE INFECTION WAS CONFIRMED.

  Patient problems: Unspecified Infection

  MAUDE report 18929360 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPSIS (STREP B) AND LOOSENING OF THE FEMORAL, SLEEVE AND STEM AT THE CEMENT TO BONE INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis

  MAUDE report 14688440 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND INSTABILITY, SUBJECTIVELY WORSE ON STAIRS WEAKNESS SUPPORTING KNEE AND HIP MUSCLES. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12691045 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE EXTRACTED AND A TEMPORARY ABX SPACER WAS PLACED. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12324882 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE EXTRACTED AND A TEMPORARY ABX SPACER WAS PLACED. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12324881 ↗
• 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 11263834 ↗
• 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 11263829 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. PATIENT HAD A RT TKA REVISION ON (B)(6) 2019, AND THEN HAD ANOTHER REVISION WITH POLY CHANGE ON (B)(6) 2019 EXCHANGING A PS RP INSERT FOR A CRS INSERT (MDR CASE NUMBER (B)(4)). THE SURGEON WANTED TO REMOVE THE SIZE 8 CRS FEMUR AND PUT IN EITHER A SIZE 9 OR 10 TO LOSE THE FLEXION GAP. THE SURGEON REMOVED THE FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM STAYED IN THE FEMUR. THE SURGEON THEN TRIALED USING A SIZE 9 AND 10 FEMUR TO CLOSE THE FLEXION GAP. THE SURGEON FELT THAT THE SIZE 10 FEMUR WOULD BE THE BEST OPTION. IMPLANTS WERE OPEN ALONG WITH AUGMENTS. THE SURGEON CEMENTED THE FEMORAL COMPONENT IN PLACE AND FELT LIKE A SIZE 10 CRS 20MM INSERT GAVE THE BEST STABILITY IN EXTENSION AND FLEXION. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10206841 ↗
• InjuryDec 11, 2019Adverse 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.

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

  MAUDE report 9450926 ↗
• InjuryDec 11, 2019Adverse 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.

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

  MAUDE report 9450923 ↗