ATTUNE 1549-07-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295383093), received between Oct 5, 2018 and Nov 13, 2025 — 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. 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID:(B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION ¿ ASEPTIC LOOSENING DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 20 OCT 2025, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION - COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL, TRUE), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23547688 ↗
• InjuryNov 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION ¿ ASEPTIC LOOSENING DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 20 OCT 2025, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION - COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL, TRUE), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23547687 ↗
• InjuryOct 23, 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 INFECTED KNEE. SURGEON PERFORMED EXPLANT AND PLACEMENT OF AB SPACER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23372985 ↗
• InjuryJul 28, 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 PAIN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22636216 ↗
• 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 22612979 ↗
• InjuryNov 1, 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 ENTRAPEMENT RAMUS INFRAPATELLARIS DEVICE AND PROCEDURE (RELATEDNESS): REMOTE POSSIBILITY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF EVENT: UNK DECEMBER 2020. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2019. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED.

  Patient problems: Nerve Damage

  MAUDE report 20590604 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A KNOWN STAPH EPI INFECTION. ALL COMPONENTS WERE REMOVED. THERE WAS NO SURGICAL DELAYS. THERE WAS NO PATIENT CONSEQUENCES. NO PARTS WERE BROKEN. LOT NUMBERS WERE NOT VISIBLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19764791 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A KNOWN STAPH EPI INFECTION. ALL COMPONENTS WERE REMOVED. THERE WAS NO SURGICAL DELAYS. THERE WAS NO PATIENT CONSEQUENCES. NO PARTS WERE BROKEN. LOT NUMBERS WERE NOT VISIBLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19764785 ↗
• 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 19058670 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED SWELLING OF LEFT KNEE EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Swelling/ Edema

  MAUDE report 17488319 ↗
• 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 16404380 ↗
• 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 13117323 ↗
• 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 12704702 ↗
• 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 12704503 ↗
• 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 12438196 ↗
• 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 12261768 ↗
• 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 12261655 ↗
• InjuryMay 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO TREAT PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO COMPETITOR CEMENT INTERFACE. THE FEMORAL SLEEVE WAS WELL-FIXED. THE TIBIAL COMPONENTS AND PATELLA WERE RETAINED. THE PATIENT WAS REVISED WITH A DEPUY LPS DISTAL FEMORAL REPLACEMENT. DOI: (B)(6) 2019. DOR: (B)(6) 2021; UNK KNEE.

  Patient problems: Pain

  MAUDE report 11891546 ↗
• InjuryMay 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO TREAT PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO COMPETITOR CEMENT INTERFACE. THE FEMORAL SLEEVE WAS WELL-FIXED. THE TIBIAL COMPONENTS AND PATELLA WERE RETAINED. THE PATIENT WAS REVISED WITH A DEPUY LPS DISTAL FEMORAL REPLACEMENT. DOI: (B)(6) 2019. DOR: (B)(6) 2021. UNK KNEE.

  Patient problems: Pain

  MAUDE report 11891544 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS POLY SPIN OUT DUE TO THE GAP BETWEEN THE FEMUR AND TIBIA BEING TOO LARGE. SURGEON IMPLANTED A HINGE WITH THICK TRAY TO CLOSE THE JOINT SPACE. NO SURGICAL DELAY HAS BEEN REPORTED. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11791184 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS POLY SPIN OUT DUE TO THE GAP BETWEEN THE FEMUR AND TIBIA BEING TOO LARGE. SURGEON IMPLANTED A HINGE WITH THICK TRAY TO CLOSE THE JOINT SPACE. NO SURGICAL DELAY HAS BEEN REPORTED. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11791154 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS NOW RECEIVED A NEURECTOMY AS TREATMENT.

  Patient problems: No Code Available

  MAUDE report 10665057 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN POST RIGHT KNEE REVISION. EXTENSIVE LAB AND ALLERGY TEST WERE DONE WHICH RESULTED IN METAL ALLERGY. ALL IMPLANTS WERE REVISED AND IMPLANTED WITH COMPETITOR IMPLANTS. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2018; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9642339 ↗
• InjuryOct 12, 2018Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE ARTHROPLASTY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE IN SEVERITY. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2018. DOE: (B)(6) 2018. PATIENT HOSPITALIZED FOR TREATMENT, EVENT IS ONGOING; LEFT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 7960159 ↗
• InjuryOct 12, 2018Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE ARTHROPLASTY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE IN SEVERITY. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2018; DOE:(B)(6) 2018. PATIENT HOSPITALIZED FOR TREATMENT, EVENT IS ONGOING. LEFT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 7960143 ↗