ATTUNE 1547-07-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295382812), received between Oct 5, 2018 and Apr 14, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Product Quality Problem” (2 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. 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24871255 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22612881 ↗
• InjuryNov 1, 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 INFECTION OF HARDWARE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20587561 ↗
• InjuryNov 1, 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 INFECTION OF HARDWARE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20587556 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED, THAT ON (B)(6) 2022, THE PATIENT WAS REVISED, DUE TO PAIN AND DEBONDING AT THE COMPETITOR TIBIAL TRAY AND DEPUY CEMENT INTERFACE. (REPORTED ON (B)(4)). AT REVISION, DEPUY COMPONENTS WERE IMPLANTED AT THAT TIME. DOI: (B)(6) 2021; DOR: (B)(6) 2022, (B)(4); AFFECTED SIDE: RIGHT KNEE. (B)(4). IT WAS REPORTED, THAT THE PATIENT CONTINUES TO HAVE PAIN/SWELLING. AND IS LOOKING AT ANOTHER REVISION.

  Patient problems: Pain

  MAUDE report 19323074 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HETEROTROPHIC OSSIFICATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT WAS REVISED.

  Patient problems: Extraskeletal ossification

  MAUDE report 17602714 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REMOVAL OF INFECTED ATTUNE REVISION. POSSIBLE INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17368416 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REMOVAL OF INFECTED ATTUNE REVISION. POSSIBLE INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17368414 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION AND THEY PUT IN A PROSTALAC SPACER. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16402723 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018; DATE OF EVENT: (B)(6) 2022; (LEFT KNEE). TREATMENT: INJECTED MEDICATION (CORTISONE).

  Patient problems: Pain

  MAUDE report 15966217 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE ARTHROFIBROSIS AND LIMITED RANGE OF MOTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF EVENT: UNK (B)(6) 2021. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 15163064 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE ARTHROFIBROSIS AND LIMITED RANGE OF MOTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: DATE OF EVENT: (B)(6) 2021. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 15162993 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE LIMITED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: UNK (B)(6) 2021. AFFECT SIDE: (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 14655648 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DSJ-2016-02 NEW CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE LIMITED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: UNK (B)(6) 2021. (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 14655610 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SLID OUT OF A WHEELCHAIR AND SUFFERED A PERIPROSTHETIC FEMUR FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION OF FEMUR.

  Patient problems: Bone Fracture(s)

  MAUDE report 13117322 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE ARTHROPLASTY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2018, (LEFT KNEE). TREATMENT: IV ANTIBIOTICS, SURGICAL I&D WITH REVISION OF ALL FEMORAL CONSTRUCT, TIBIAL CONSTRUCT, INSERT COMPONENTS ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 12704974 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE ARTHROPLASTY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2018, (LEFT KNEE). TREATMENT: IV ANTIBIOTICS, SURGICAL I&D WITH REVISION OF ALL FEMORAL CONSTRUCT, TIBIAL CONSTRUCT, INSERT COMPONENTS ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 12704931 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED AS "SURGEON THOUGHT FEMUR WAS LOOSE BECAUSE PATIENT WAS EXPERIENCING PAIN. UPON INSPECTION AND REMOVAL OF FEMUR IT WAS FOUND THAT THE FEMUR WAS WELL FIXED AND THAT THE KNEE NEEDED TO BE CLEANED UP FROM OSTEOPHYTES THAT MAY HAVE BEEN CAUSING THE PAIN WHEN THE KNEE ROTATED. THE FEMORAL SLEEVE WAS COVERED IN BONE GROWTH AND WAS WELL FIXED. SURGEON IMPLANTED A SROM HINGE FEMUR." NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12438207 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED AS "SURGEON THOUGHT FEMUR WAS LOOSE BECAUSE PATIENT WAS EXPERIENCING PAIN. UPON INSPECTION AND REMOVAL OF FEMUR IT WAS FOUND THAT THE FEMUR WAS WELL FIXED AND THAT THE KNEE NEEDED TO BE CLEANED UP FROM OSTEOPHYTES THAT MAY HAVE BEEN CAUSING THE PAIN WHEN THE KNEE ROTATED. THE FEMORAL SLEEVE WAS COVERED IN BONE GROWTH AND WAS WELL FIXED. SURGEON IMPLANTED A SROM HINGE FEMUR." NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12438205 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LEFT ATTUNE REVISION TOTAL KNEE REPLACEMENT. PATIENT UNDERWENT REVISION OF LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2021 TO ATTUNE REVISION PROSTHESIS, RP WITH STEMS AND SLEEVES TO BOTH THE TIBIA AND FEMUR. THE PATIENT HAS AN UNDERLYING CONDITION CALLED CHARCOT-MARIE-TOOTH DISORDER. PATIENT PRESENTED BACK TO SURGEON WITH INSTABILITY AND HYPEREXTENSION OF HIS LEFT KNEE. PROCEDURE PERFORMED TODAY WAS REVISION OF LEFT ATTUNE REVISION PROSTHESIS TO LPS DISTAL FEMORAL REPLACEMENT. THE TIBIAL CONSTRUCT WAS ASSESSED TO BE STABLE AND WAS NOT REVISED. THE FEMORAL CONSTRUCT OF FEMUR, SLEEVE AND STEM WAS REVISED AND A DISTAL FEMORAL REPLACEMENT PROSTHESIS WAS INSERTED. DOI: (B)(6) 2021. DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 12390908 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. DATE OF IMPLANTATION (B)(6) 2021. B. LOT NUMBER: ATTUNE CRS FEMORAL RT SZ 7 CEM (150440207), LOT # J8602J. ATUNE PRESSFIT STR STEM24X60MM (151324060) , LOT # J06R66. REFER TO ADDITIONAL EVENT INFORMATION A-6001132 WHICH HAS THE USAGE FROM THE PRIMARY SURGERY. C. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. UNKNOWN. D. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

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

  MAUDE report 12261659 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REVISION TOTAL KNEE DONE ELSEWHERE. CAME IN WITH INFECTION. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS INSERTED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9853262 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND STIFFNESS OF THE KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Muscular Rigidity; No Code Available; Pain

  MAUDE report 9811071 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS ALSO REPORTED THAT THE ATTUNE REVISION IMPLANTED ON (B)(6) WAS EXPLANTED TODAY TO STATIC SPACER. POLY HAD BEEN REPLACED ON (B)(6); THAT ONE WAS ALSO REMOVED TODAY. DOI: (B)(6) 2019; (B)(6) 2019 (INSERT); DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9278564 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS ALSO REPORTED THAT THE ATTUNE REVISION IMPLANTED ON (B)(6) WAS EXPLANTED TODAY TO STATIC SPACER. POLY HAD BEEN REPLACED ON (B)(6); THAT ONE WAS ALSO REMOVED TODAY. DOI: (B)(6) 2019, (B)(6) 2019 (INSERT); DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9274328 ↗