ATTUNE 1517-10-810Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295056256), received between Dec 11, 2019 and Jan 28, 2026 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24203767 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN INFECTION IN THE KNEE, RESULTING IN AN IRRIGATION AND DEBRIDEMENT PROCEDURE WITH LINER EXCHANGE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23978071 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME INFECTED, REMOVED POLY AND PUT A NEW ONE IN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22292631 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED IN ER WITH A STIFF PAINFUL KNEE. A POLY EXCHANGE AND THOROUGH I & D WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM OCCURRED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. LOT INFORMATION IS UNAVAILABLE IN OPTIMIZE DUE TO THE MIGRATION FROM COMPASS. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain; Unspecified Infection

  MAUDE report 21079099 ↗
• 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 19126182 ↗
• InjuryApr 16, 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 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: UNK (B)(6) 2023 (RIGHT KNEE) TREATMENT: DIAGNOSTIC INTERVENTION AND RESECTION OF HETEROTOPIC BONE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19117320 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? NO. C. WAS THERE AN INFECTION RELATED TO IRRIGATION AND DEBRIDEMENT PROCEDURE? UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18969652 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH A POLY SWAP. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17886830 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16094213 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15163746 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PAIN. THE SURGEON WENT IN AND REMOVED SCAR TISSUE. THE SURGEON ALSO REMOVED THE POLY INSERT TO IMPROVE EXPOSURE TO DEBRIDE SCAR TISSUE. HE FOUND THE COMPONENTS WELL FIXED AND ALIGNED. HE REPLACED THE INSERT WITH THE SAME SIZE AS REMOVED. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 13930665 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAS A LONG HISTORY OF LT TKA WITH EXPLANT FOR INFECTION. INITIAL DOS (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; EXPLANT LEFT TKA WITH ANTIBIOTIC SPACER (B)(6) 2020; ATTUNE LEFT TKA REPLANT (B)(6) 2020; RE-INFECTED WITH EXPLANT AND SPACER (B)(6) 2021 WITH ALL HARDWARE REMOVED. THIS COMPLAINT IS FOR THE 6TH REVISION. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12737186 ↗
• 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 11263911 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF FEMORAL COMPONENT AT CEMENT TO BONE INTERFACE. AN UNKNOWN CEMENT WAS USED. THE PLAN WAS REVISION OF THE FEMORAL COMPONENT, BUT CULTURES TAKEN INTRA-OP TURNED OUT POSITIVE FOR INFECTION. ALL COMPONENTS WERE REVISED AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10299999 ↗
• 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 9450940 ↗