ATTUNE 1504-10-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10603295041610), received between Oct 24, 2017 and Sep 21, 2026 — classified as 60 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (13 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 63 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50847134 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTHROFIBROSIS AND INSTABILITY HAD OCCURRED. THE PATELLA WAS STABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Arthrofibrosis; Joint Laxity

  MAUDE report 25395880 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  DUE TO PAIN AFTER TKA, SCINTIGRAPHY EXAM WAS PERFORMED. EXAM SHOWED POSSIBLE LOOSENING OF IMPLANT. DECISION HAS BEEN DONE TO EXPLANT PROSTHESIS AND IMPLANT A REVISION SYSTEM. IT WAS LATER ADDED THAT NO LOOSENING WAS OBSERVED.

  Patient problems: Pain

  MAUDE report 25348421 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A FRACTURED FEMUR. REVISING TO A REVISION TOTAL KNEE WITH A FEMUR PLATE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 24828119 ↗
• InjuryFeb 27, 2026Loss of or Failure to Bond

  HEALTH AUTHORITY REPORT MW5181909 WAS REPORTED TO MANUFACTURER: IT WAS REPORTED THAT ATTUNE RP TIB BASE SZ 4 CEM, ATTUNE MEDIAL DOME PAT 38MM, ATTUNE PS FEM LT SZ 4 CEM, AND UNKNOWN KNEE TIBIAL INSERT WERE ASSOCIATED WITH A REPORTED EVENT. THE PATIENT EXPERIENCED INCREASED SWELLING, PAIN, DECREASED MOBILITY, AND WALKING DIFFICULTY FOLLOWING A TOTAL KNEE REPLACEMENT. IMAGING INDICATED POSSIBLE IMPLANT LOOSENING, AND A REVISION SURGERY WAS PERFORMED WITH A DIAGNOSIS OF FAILED ARTHROPLASTY AND AN OCCULT FRACTURE OF THE ANTERIOR TIBIA. THE TIBIAL INSERT WAS REVISED TO PROVIDE ACCESS TO THE SURGICAL SITE, AND IT WAS NOTED THAT THE LOOSE IMPLANTS MAY HAVE CONTRIBUTED TO THE EVENT DUE TO THEIR BONDING INTERFACE AND RESISTANCE TO LOOSENING. THE IMPLANTS WERE EXPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 24469123 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23922568 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND KNEE BECAME UNSTABLE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Joint Laxity

  MAUDE report 20345248 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO TREAT INFECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. DOI: (B)(6) 2024, DOR:(B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20174866 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19938152 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER PUT IN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19656850 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY INVOLVING ATTUNE COMPONENTS. THE PATELLA WAS RESURFACED AND SMARTSET CEMENT X 2 WAS USED. ON (B)(6) 2024, THE PATIENT UNDERWENT A LEFT KNEE REVISION FOR INSTABILITY. INTRAOPERATIVELY, THE TIBIAL COMPONENT WAS COMPLETELY DEBONDED AT AN UNKNOWN INTERFACE. THE PATIENT HAD SEVERE OSTEOLYSIS AND A TIBIAL PLATEAU FRACTURE. THE FRACTURE WAS REPAIRED WITH A SMALL TRABECULAR METAL CONE AND BONE GRAFTS. COMPETITOR PRODUCTS WERE PLACED DURING THE REVISION WHILE THE ATTUNE PATELLA WAS LEFT IN SITU. DOI: (B)(6) 2015 DOR: (B)(6) 2024 (LEFT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 19636933 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19115869 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL COMPONENTS WERE REMOVED EXCEPT FOR THE PATELLA. REASON FOR REVISION WAS DUE TO INSTABILITY, PARTICULARLY MID FLEXION INSTABILITY. THEY HAVE HAD BOTH SIDES DONE, BUT WERE NEVER HAPPY WITH THIS SIDE. COMPONENTS WERE ALL WELL FIXED. SURGEON NOTED THAT THE TIBIAL SLOPE DID NOT LOOK RIGHT, AND THERE WAS ALSO BONE LEFT OUT THE BACK FROM THE PRIMARY TIBIAL RESECTION WHICH WAS NOT ADEQUATELY CLEARED. THEY WERE ALSO TIGHTER IN EXTENSION RELATIVE TO FLEXION, SO WAS NOT A BALANCED KNEE. DOI: (B)(6) 2021. DOE: (B)(6) 2024.

  Patient problems: Joint Laxity

  MAUDE report 18852334 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR LEFT PERIPROSTHETIC FEMUR FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE NOR PROCEDURE. DATE OF IMPLANT: (B)(6) 2012. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ORIF LEFT FEMUR.

  Patient problems: Bone Fracture(s)

  MAUDE report 18160215 ↗
• InjuryJun 16, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL NOTES RECEIVED. (B)(6) 2021 LEFT TOTAL ARTHROPLASTY TO ADDRESS ARTHRITIS. COMPETITOR CEMENT ALONG WITH DEPUY TIBIAL TRAY, TIBIAL INSERT, FEMORAL COMPONENT AND PATELLA WERE IMPLANTED. ON (B)(6) /2022 THE PATIENT REPORTS LEFT KNEE PAIN AND SWELLING, INFECTION WAS NOTED. MEDICAL RECORDS (B)(6) 2023 BONE SCAN WAS NOTED SHOW INCREASED FLOW TO THE KNEE, WHICH IS SUGGESTIVE OF PROSTHETIC LOOSENING. THERE WAS NO INFORMATION PROVIDED THAT NOTED REVISION, INVASIVE TREATMENT, OR PERMANENT INJURY.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17144998 ↗
• MalfunctionMay 18, 2023Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON FELT THE PACKAGING WAS COMPROMISED ON THE FEMORAL IMPLANT. THE TAB TO REMOVE THE FINAL LAYER WAS GLUED TO THE UNDERSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952851 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16876354 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND THE SURGEON FELT THAT THE RP INSERT CONTRIBUTING TO SYNOVITIS. THE IMPLANTS WERE WELL FIXED AND WELL ALIGNED. REMOVED THE TRAY AND PLACED A FIXED BEARING TIBIA AND INSERT. CHANGED THE PATELLA AFTER CUT TO THIN- TRACKING LATERALLY. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 15649798 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15520277 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  A CALL FROM A CUSTOMER WAS RECEIVED STATING THAT "I WANT TO KNOW WHO I CAN TALK ABOUT MY KNEE REPLACEMENT. I'M HAVING A PROBLEM WITH IT AND IT'S BEEN RECALLED EVEN BEFORE MY DOCTOR PUT IT IN ME. AND SINCE THEN I START TO HAVE PROBLEM WITH IT. SHOULD I CALL A LAWYER FOR THE COMPENSATION?" DOI: (B)(6) 2019; DOR: (B)(6) 2020; UNKNOWN KNEE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15281842 ↗
• InjuryAug 9, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE IMPLANT DETACHED FROM THE CEMENT.

  Patient problems: Pain

  MAUDE report 15194378 ↗
• InjuryJul 6, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  REVISION COMPLETED DUE TO LOOSENING. PATIENT COMPLAINED OF KNEE PAIN ABOUT TWO YEARS AGO. PATIENT FAILED TO COME BACK IN FOR A CHECK UP OR AGREE TO SURGERY UNTIL TODAY. THE FEMUR AND TIBIA WERE BOTH LOOSE AND HAD SUBSIDED FROM THE BONE. BOTH IMPLANTS CAME OUT WITH LITTLE TO NO WORK AS SHE HAD BEEN WALKING ON THEM FOR SO LONG WITH THIS PROBLEM. THE SURGEON REPLACED THE IMPLANTS WITH ATTUNE REVISION. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14930917 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL ATTUNE KNEE WITH A GAP MISBALANCE. THE KNEE WAS TOO TIGHT IN FLEXION WITH NORMAL EXTENSION. THE SURGEON DECIDED THAT THE ONLY WAY TO SOLVE THE BALANCE ISSUE WAS TO REMOVE THE FEMUR AND THE TIBIAL TRAY. THESE COMPONENTS WERE WELL FIXED. THE PATELLA WAS WELL FIXED AND RETAINED. THE SURGEON WAS ABLE TO GET THE KNEE TO BALANCE BETTER WITH NEW COMPONENTS. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Laxity; Muscular Rigidity

  MAUDE report 14346104 ↗
• MalfunctionMar 3, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING THE PREPARATION FOR IMPLANTING THE ATTUNE FEMUR COMPONENT A FOREIGN BODY WAS VISIBLE ON THE FEMURCONDYLE. THE FIRST IMPRESSION OF THE OR TEAM WAS THAT IT WAS A SCRATCH BUT IT WAS A FOREIGN MATERIAL. THERE WAS A FIFTEEN MINUTE SURGICAL DELAY. FOR THE PATIENT NO CONSEQUENCES OCCURRED BECAUSE THE FOREIGN BODY WAS DETECTED BEFORE THE IMPLANTATION STARTED. THERE WAS A TIME DELAY BECAUSE A NEW IMPLANT NEEDED TO BE PREPARED FOR IMPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 13659966 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS INSTABILITY. LOOSENING WAS NOT DETERMINED IN SURGERY. DOI: (B)(6) 2017, DOR:(B)(4) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13571663 ↗