ATTUNE 1504-00-224Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295041276), received between Aug 9, 2017 and May 27, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH PERSISTENT PAIN AND POOR ROM POST TKA BY AN OUTSIDE SURGEON AND POLY AND PATELLA EXCHANGE ON (B)(6) 2023 BY THE TREATING SURGEON. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED. PATIENT BELIEVES SHE HAS AN ALLERGY TO NICKEL AND WELL-FIXED FEMUR, POLY AND TIBIA WERE REMOVED AND THE COMPONENTS WERE REVISED TO A COMPANY OFFERING NICKEL FREE ALTERNATIVE PROSTHESES. NO DELAY NOR PATIENT HARM IS NOTED. NO ALLEGATION IS MADE AGAINST ANY COMPONENT. PATELLA COMPONENT WAS LEFT IN PLACE FROM (B)(6) 2023 AS IT WAS WELL FIXED AND TRACKS WELL. NO LOT INFORMATION WAS AVAILABLE IN OPTIMIZE AS THIS INFORMATION WAS NOT TRANSFERRED IN THE MIGRATION FROM COMPASS TO OPTIMIZE. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25304421 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21738067 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A TKA FOR OA. ON (B)(6) 2023, THE PATIENT HAD A SUPRACONDYLAR FEMORAL FRACTURE. THEREFORE, ON (B)(6) 2023, THE IMPLANTS (ATTUNE) WILL NOT BE REMOVED OR REPLACED, BUT AN OSTEOSYNTHESIS WILL BE PERFORMED USING A RETROGRADE INTRAMEDULLARY NAIL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Limb Fracture

  MAUDE report 18142305 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MEDICAL EPICONDYLE FRACTURE FIXED WITH 2 SCREWS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 17162842 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DEHISCENCE DUE TO SUTURE REACTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2015. DATE OF EVENT: (B)(6) 2015. (RIGHT KNEE) TREATMENT: MEDICAL INTERVENTION/ MODIFICATION (UNSPECIFIED).

  Patient problems: Wound Dehiscence

  MAUDE report 15978833 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE ARTICLE ENTITLED, ¿DOES CIRCUMFERENTIAL PATELLAR DENERVATION RESULT IN DECREASED KNEE PAIN AND IMPROVED PATIENT-REPORTED OUTCOMES IN PATIENTS UNDERGOING NON-RESURFACED, SIMULTANEOUS BILATERAL TKA?¿ BY NICOLAAS C. BUDHIPARAMA MD, ET AL, PUBLISHED BY CLINICAL ORTHOPAEDICS RELATED RESEARCH (2020), VOL. 428, PP. 2020-2033 WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF PATELLAR DENERVATION IN 78 PATIENTS RECEIVING BILATERAL ATTUNE PRIMARY TKAS WITHOUT PATELLAR RESURFACING BETWEEN FEB 2015 AND OCTOBER 2016. IN ALL BILATERAL PROCEDURES, THE PATELLAR DENERVATION VIA CAUTERIZATION OF THE PATELLAR RIM WAS ALWAYS PERFORMED ON THE RIGHT KNEE. THE AUTHORS CONCLUDED THAT THERE WAS NO CLINICAL DIFFERENCE BETWEEN THE CAUTERIZED AND NON-CAUTERIZED KNEES. PATIENT 2: DOI (B)(6) 2016. PATIENT RECEIVED A BILATERAL PRIMARY ATTUNE TKA TO TREAT OSTEOARTHRITIS OF KNEE GRADE 4. THE PATELLA WAS NO RESURFACED AND SMARTSET GENTAMYCIN CEMENT X1 WAS UTILIZED. SURGERY PERFORMED USING MEDIAL PARAPATELLAR STANDARD APPROACH AND HYBRID METHOD (MEASURED RESECTION + GAP BALANCING) USED FOR CUTTING AND ROTATIONAL REFERENCE TOWARD MECHANICAL AXIS. THE PROCEDURE WAS COMPLETED WITHOUT CO

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 11186952 ↗
• InjuryDec 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2019, THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING RIGHT TOTAL KNEE. COMPETITOR COMPONENTS WERE USED DURING THIS PROCEDURE. DURING THE PROCEDURE THE SURGEON OBSERVED LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENTS AT THE CEMENT/IMPLANT INTERFACE. THE INSERT WAS NOTED TO HAVE NO EVIDENCE OF WEAR. THE PATELLA WAS NOTED TO BE STABLE AND WAS NOT REVISED.

  Patient problems: Insufficient Information

  MAUDE report 10937392 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFF RIGHT TKA : ADHESIONS EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: CLOSED KNEE MANIPULATION UNDER ANESTHESIA ON (B)(6) 2020.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 10929525 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, MILD FLEXION INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AT BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. ALL PARTS WERE REMOVED EXCEPT THE PATELLA. A NEW TC3 WAS IMPLANTED AND SHE HAD A FULL RANGE OF MOTION FROM FLEXION TO FULL EXTENSION. DOI: (B)(6) 2015; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10763397 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS NOTED A THIRD PROCEDURE WAS PERFORMED ON THE RIGHT KNEE SEVERAL WEEKS AFTER THE PROCEDURE ON (B)(6) 2017. THE PROCEDURE WAS COMPLETED FOR ASPIRATION OF FLUID ON THE RIGHT KNEE. THERE IS NO EVIDENCE NOR ALLEGATION THAT ANY PRODUCTS WERE REVISED DURING THE PROCEDURE. THE PROCEDURE NOTES WERE NOT AVAILABLE AT THE TIME OF REVIEW. DOI: (B)(6) 2017, DOE 1: (B)(6) 2017 ((B)(4)), DOE 2: UNKNOWN, RIGHT KNEE.

  Patient problems: Edema; No Code Available

  MAUDE report 10493885 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECORDS INDICATE THE PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT WAS REVISED DUE TO PAIN AND PATELLAR TENDON RUPTURE DUE TO LOOSENING OF UNSPECIFIED COMPONENTS. THE AVAILABLE NURSE¿S NOTES INDICATE THAT THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENTS WERE REVISED. THERE WAS NO INDICATION THAT THE PATELLA WAS REVISED. THE PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCTS. THERE WERE NO PHYSICIAN OPERATIVE NOTES PROVIDED. DOI: (B)(6) 2015. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9874310 ↗
• InjuryDec 20, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF ALL COMPONENTS. DECREASED ACTIVITY, AND PAIN. THE SURGEON INDICATED AFTER SEVERAL IMPACTIONS WITH A BONE TAMP MALLET, THE TIBIAL BASEPLATE DISLODGED FROM THE CEMENT MANTLE AND WAS REMOVED. HE REPORTED THE FEMORAL COMPONENT CAME OUT WITH SEVERAL IMPACTIONS OF THE BONE TAMP AND MALLET AND WAS RELATIVELY EASY TO REMOVE. THE SURGEON INDICATED THE PATELLA WAS GROSSLY LOOSE AND REMOVED FROM ITS CEMENT BED WITH LITTLE EFFORT USING A TONSIL. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2016 (RT KNEE).

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

  MAUDE report 9503693 ↗
• InjuryNov 21, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 1. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, AND PAIN. THE SURGEON REPORTED THE TIBIAL TRAY HAD SUBSIDED SIGNIFICANTLY AND WAS GROSSLY LOOSE. HE NOTED FEMORAL COMPONENT WAS GROSSLY LOOSE AND HE WAS ABLE TO REMOVE IT BY GRASPING IT WITH A RONQUER. THE SURGEON REPORTED SIGNIFICANT BONE LOSS ABOUT THE MEDIAL AND LATERAL CONDYLES PRIOR TO ANY BONY RESECTIONS. THE SURGEON OFFERED NO COMPLAINTS REGARDING THE AND IT WAS NOT WAS REVISED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH ATTUNE KNEE SYSTEM AND DEPUY CEMENT X 4. DOI: (B)(6) 2014; DOR: (B)(6) 2018 (RT KNEE).

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 9355924 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, METAL ALLERGY, ARTHROFIBROSIS, STIFFNESS, AND ADHESIONS. THE SURGEON INDICATED ASEPTIC LOOSENING AS ONE OF THE POST-OPERATIVE DIAGNOSES, HOWEVER, THERE IS NO MENTION OF LOOSENING WITHIN THE REVISION OPERATIVE PROCEDURE NOTE. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Adhesion(s); Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9273426 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014. DOR: (B)(6) 2016 RIGHT KNEE.

  Patient problems: Fibrosis; No Code Available; Pain

  MAUDE report 8977687 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, SYNOVITIS, AND NICKEL ALLERGY. ALL COMPONENTS WERE NOTED TO BE WELL-FIXED. THE PATELLA COMPONENT WAS NOT REVISED. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018, RIGHT KNEE.

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

  MAUDE report 8861384 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO DEFICIENCY/PROBLEM WITH THIS PRODUCT. STIFFNESS AND PAINFUL (ARTHROFIBROSIS). THE PRIMARY IMPLANT WELL FIXED AND NO ISSUES.

  Patient problems: No Code Available; Pain

  MAUDE report 8587389 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED MEDICAL RECORDS ON 06/26/2018. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. RIGHT ATTUNE TOTAL KNEE REVISED TO ADDRESS PAIN AND INSTABILITY. REVISING SURGEON NOTED THAT THE PCL WAS INCOMPETENT, ON A CR NON-STABILIZED KNEE REPLACEMENT. ATTUNE FEMUR, TIBIAL TRAY, AND TIBIAL INSERT COMPONENTS WERE REVISED TO COMPETITOR PRODUCTS; THE ATTUNE PATELLA COMPONENT WAS RETAINED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY SURGERY. DOI: (B)(6) 2016; DOR: (B)(6) 2017; (RIGHT KNEE).

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7901381 ↗
• InjuryAug 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE: 17JUL2017: CLINICAL DER STATES THAT THE PATIENT WAS REVISED FOR AN UNKNOWN REASON. WHAT DEPUY PRODUCTS WERE REVISED IS UNKNOWN AS WELL. IT SHOULD BE NOTED THAT THE PATIENT HAS WITHDRAWN FROM THE STUDY DUE TO WITHDRAWAL OF CONSENT. THIS COMPLAINT WAS UPDATED ON 25JUL2017.

  Patient problems: Pain

  MAUDE report 6778267 ↗