ATTUNE 1506-80-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295492214), received between Feb 28, 2020 and Aug 18, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that revision of RT knee for infection: 9PS Femur, 9x5mm PS insert, 9RP Tibia.Affected Side: Right Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50300079 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTION. ALL COMPONENTS WERE REMOVED. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24177998 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SEPTIC MOBILIZATION OF RIGHT KNEE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22204517 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FLEXION EXTENSION WAS MISMATCH. SURGEON ELECTED TO REPLACE THE IMPLANTS WITH AN ATTUNE REVISION KNEE. DOI: (B)(6) 2019, DOR: (B)(6) 2024 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19351697 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REFERRED TO SURGEON WITH AN INFECTED TOTAL KNEE. SURGEON OPTED TO DO A TWO STAGE REVISION WITH PLACEMENT OF AN ANTIBIOTIC SPACER UNTIL THE INFECTION HAS CLEARED. AT THIS POINT HE WILL RE-IMPLANT AN ATTUNE REVISION. ALL IMPLANTS WERE REMOVED AND A SURESPACE SPACER MOLD WAS IMPLANTED WITH DEPUY 1 W/ GENT. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17263375 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE BECAME INFECTED AS THE REASON FOR REMOVAL. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17215806 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED JOINT. IMPLANTS WERE REMOVED, JOINT WAS WASHED OUT, I&D, CRS FEMUR AND RP CRS INSERT WERE IMPLANTED AS A SPACER. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17165246 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED KNEE. SURESPACE ARTICULATING SPACER MOLD WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16938280 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMUR AND TIBIA WHERE REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16478035 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D RIGHT KNEE WAS PERFORMED WITH TEMPORARY SPACERS. LAST SURGERY WAS (B)(6) 2021 WITH SURGEON AT HOSPITAL FOR A POLY SWAP. ON (B)(6) 2022, SURGEON REMOVED EVERYTHING BUT PATELLA AND REPLACED WITH FEMUR AND RP INSERT AS TEMP SPACER. NO ADDITIONAL INFORMATION PROVIDED. DER WAS ALREADY PROVIDED FOR THIS PATIENT BACK FOR THE (B)(6) 2021 POLY SWAP. THE SALES REP WANTED TO PROVIDE THE COMPLAINT NUMBER FOR THAT DER, IT IS: (B)(4). 1ST DOI: (B)(6) 2019. 2ND DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15391810 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVED AN ATTUNE TKA DUE TO INFECTION. DOI: UNK; DOR: UNK; UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15249724 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A LOOSE IN FLEXION AND EXTENSION. CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14753383 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1. PLEASE CLARIFY, WHAT WERE THE PRODUCTS REMOVED DUE TO INFECTION? BASED ON THE IMPACTED PRODUCTS REPORTED, ONLY THE PRODUCT RETURN STATUS OF THE TIBIAL INSERT WAS DISCARDED. 2. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? 3. WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE PRODUCT(S). IF YES, PLEASE PROVIDE DETAILS. 4. WAS THE CEMENT PRODUCT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS AND QUANTITY OF THE CEMENT. 5. CAN YOU PLEASE PROVIDE THE LOT NUMBER FOR THE REPORTED PRODUCTS (ATTUNE PS FEM RT SZ 9 CEM) AND (ATTUNE MEDIAL DOME PAT 41MM)? 6. PATIENT DEMOGRAPHICS & COMORBIDITIES 7. RADIOGRAPHS/X-RAY FILMS AND OP NOTES IF AVAILABLE. RESPONSE: I HAVE PROVIDED ALL THE INFORMATION AVAILABLE. THE ONLY IMPLANT REVISED WAS THE BEARING AS IT IS A WASHOUT OR DAIR PROCEDURE FOR INFECTION AS REPORTED. DAIR IS DEBRIDEMENT, ANTIBIOTICS, IMPLANT RETENTION, A PROCEDURE FOR INFECTION WHILE RETAINING THE PROTHESIS. IT IS A COMMON ANACRONYM FROM THE PAST FIVE YEARS. THE IMPLANTS WERE MARKED UNAVAILABLE IMPLANTED WHICH WAS FOR ALL EXCEPT THE BEARING WHICH WAS DISCARDED TO ALLOW THOROUGH IRRIGATION OF

  Patient problems: Unspecified Infection

  MAUDE report 14043771 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. ORIGINAL PROSTHESIS WAS REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 13654516 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT TOTAL KNEE THAT IS INFECTED. THE SURGEON REMOVED THE COMPONENTS AND IMPLANTED TEMPORARY PARTS. ALL COMPONENTS WERE WELL FIXED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12200687 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ACUTE SWELLING. SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT WITH REMOVAL OF COMPONENTS AND PLACEMENT OF ANTIBIOTIC SPACER WITH ATTUNE PS FEMUR AND RP INSERT. THERE WAS NO INDICATION OF GROSS INFECTION. THE KNEE WAS FILLED WITH OLD BLOOD. ALL COMPONENTS WERE REMOVED EXCEPT THE PATELLA. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 11516740 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO COMPLAINING OF LATERAL PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11293605 ↗
• InjuryJan 20, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ASEPTIC LOOSENING OF TIBIA, REVISED ENTIRE KNEE. RIGHT KNEE DONE BY DR. (B)(6) IN 2018.

  Patient problems: Insufficient Information

  MAUDE report 11201741 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE CEMENT USED WAS NOTED TO BE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11172731 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STILL LEFT TOTAL KNEE ARTHROPLASTY/ADHESIONS; FAILURE TO PROGRESS IN PHYSICAL THERAPY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA ON (B)(6) 2020.

  Patient problems: Adhesion(s)

  MAUDE report 11148212 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. EXPLANT OF IMPLANTS AND INSERTED ANTIBIOTIC SPACER. NO ADDITIONAL INFORMATION AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 10959854 ↗
• InjuryNov 24, 2020Adverse 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. ONE STAGE REVISION WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1516-50-910 WAS IMPLANTED ON (B)(6) 2020. DOI: (B)(4) 2020, DOI (INSERT): (B)(6) 2020, DOR: (B)(4) 2020, RIGHT KNEE.

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

  MAUDE report 10898050 ↗
• InjuryNov 2, 2020Adverse 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. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10774594 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, MID-FLEXION INSTABILITY AND TIGHTNESS IN FLEXION. PATHOLOGY CONFIRMED THAT THERE WAS NO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH ATTUNE REVISION CRS WITH SLEEVES AND STEMS. AFTER REMOVAL OF COMPONENTS, THE SURGEON CONFIRMED THAT NOTHING WAS LOOSE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10621826 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR FLEXION INSTABILITY PCL RUPTURE, ALL COMPONENTS REVISED EXCEPT THE PATELLA.

  Patient problems: No Code Available

  MAUDE report 9771885 ↗