ATTUNE 1506-60-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295042921), received between Dec 11, 2019 and Mar 31, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIA AND FEMUR LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24747416 ↗
• InjuryAug 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT FULL ATTUNE KNEE REVISION DONE IN (B)(6) 2023. PATIENT STARTED TO EXPERIENCE TIBIA PAIN ABOUT 3 MONTHS AGO. SURGEON DID A BONE SCAN AND FOUND THE TIBIA WAS ¿HOT¿. SURGEON FELT THE TIBIA STEM WAS CAUSING THE TIBIA COMPONENT TO BECOME LOOSE. REMOVED ONLY THE TIBIA AND DID A TIBIA ONLY REVISION. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE,

  Patient problems: Pain

  MAUDE report 22904909 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THEY USED DEPUY CEMENT BUT IT'S NOT MARKED IN THE CHART AS TO WHICH SURGERY THE CEMENT WAS FOR SO THEY HAVE NO INFORMATION REGARDING CEMENT NUMBERS. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22384709 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA WAS REVISED. TIBIA HAD DEVELOPED A LESION UNDERNEATH OF IT AT PROXIMAL MEDIAL DUE TO PATIENT BEING IMMUNE COMPROMISED. PRIOR MULTIPLE SURGERIES WERE PERFORMED. TIBIA WAS NOT LOOSE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Notching

  MAUDE report 22344623 ↗
• InjuryFeb 19, 2025Adverse 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 KNEE INFECTION . COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21410134 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: HOSPITALIZATION (INITIAL OR PROLONGED): YES => NO. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: NO => YES.

  Patient problems: Abscess

  MAUDE report 20831690 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS NO.

  Patient problems: Unspecified Infection

  MAUDE report 20492420 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED LEFT KNEE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20398982 ↗
• InjurySep 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT CAME BACK IN TO SEE DOCTOR WITH REDNESS (HOTNESS) AND PAIN IN PATIENT'S RTK. AFTER TESTING THEY DETERMINED THE KNEE TO BE SEPTIC AND A REVISION WAS NEEDED. UPON OPENING THE JOINT THE COMPONENTS APPEARED TO BE LOOSE AND THERE WAS BONE LOSS BETWEEN THE CEMENT MANTLE AND THE BONE. THE COMPONENTS WERE REMOVED, THE JOINT WAS THOROUGHLY IRRIGATED AND THE CANALS WERE REAMED OUT. AFTERWARDS NEW REVISION COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2022, DOR: (B)(6), 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Erythema; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20267199 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO BE REINFECTED AFTER A 2-STAGE REVISION TKA. ALL COMPONENTS WERE REMOVED, AND A THOROUGH DEBRIDEMENT WAS PERFORMED. A SPACER WAS PLACED USING LPS COMPONENTS, INCLUDING THE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND COATING THE PROSTHESIS WITH HIGH-DOSE ANTIBIOTIC CEMENT. NO DELAY OR PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION AGAINST ANY DEPUY COMPONENT; THEY WERE SIMPLY REMOVED DUE TO INFECTION. CEMENT WAS HOSPITAL-OWNED, SO LOT INFORMATION WAS UNAVAILABLE, BUT THE SURGEON'S ROUTINE INVOLVED USING DEPUY 2 WITH GENT FOR REVISION CASES. ALL PART AND LOT INFORMATION WAS COPIED AND PASTED DIRECTLY FROM OPTIMIZE AND WAS ACCURATE PER THAT SYSTEM. DOI: ON (B)(6) 2024; DOR: ON (B)(6) 2024 ; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19928243 ↗
• InjuryApr 18, 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 19133445 ↗
• 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 19117311 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTION. ALL IMPLANTS WERE TAKEN OUT AND PS FEMUR AND ALL POLY TIBIA WERE IMPLANTED. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18073152 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6), DOR: (B)(6), AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16732429 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16023186 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS A COMPETITOR. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 15347434 ↗
• InjuryJun 2, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED TO ADDRESS PAIN AND LOOSENING OF THE UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14573098 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REMOVAL OF IMPLANTS FOR INFECTION AND IMPLANTED A SPACER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14101519 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL IMPLANTS REMOVED SECONDARY TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13096479 ↗
• 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 12690975 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2020, THE PATIENT UNDERWENT INITIAL TKA SURGERY ON KNEE FOR SUBLUXATION WITH OTHER COMPANY'S PRODUCTS. IN (B)(6) 2021, THE IMPLANT WAS REMOVED DUE TO INFECTION, AND A CEMENT MOLD CONTAINING ANTIBIOTICS WAS PLACED. IN (B)(6) 2021, TKA REOPERATION WAS PERFORMED (DEPUY/ATTUNE REVISION/RP) WITH THE IMPLANTS. ON (B)(6) UNKNOWN DATE, 2021, SPIN-OUT OCCURRED. ON (B)(6) 2021, THE RP TIBIAL TRAY WAS REMOVED AND REPLACED WITH AN FB TIBIAL TRAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11893878 ↗
• 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 11263801 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INFECTION AS A CONSEQUENCE OF PERIPROSTHETIC JOINT INFECTION; SEPTIC MULTI ORGAN FAILURE DUE TO ACUTE PERIPROSTHETIC JOINT INFECTION OF THE LEFT KNEE AND EMPYEMA OF THE RIGHT KNEE AND LEFT SHOULDER. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF REVISION: (B)(6) 2020; (LEFT KNEE.

  Patient problems: No Code Available; Sepsis; Unspecified Infection

  MAUDE report 10831787 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10460637 ↗
• InjuryJun 10, 2020Migration; Migration

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED TODAY AS THEY MIGRATED INTO VALGUS. DOI: (B)(6) 2018. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10137736 ↗