ATTUNE 1504-00-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295041061), received between Oct 26, 2017 and Apr 1, 2026 — classified as 59 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE IMPLANTS DUE TO QUAD TENDON AND IMPLANT HUMERAL ROD AS STATIC SPACER. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24753744 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SURGEON SUSPICION OF INFECTION. NO OTHER INFORMATION IS KNOWN. DOI-(B)(6) 2024. DOR (B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24691221 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REPLACEMENTS SURGERY IN 2024 ON BOTH KNEES. FOLLOWING THE KNEE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED A SERIES OF ADVERSE EVENTS INCLUDING INFECTION, WOUND DEHISCENCE, BLEEDING, ALLERGIC REACTION TO NICKEL, FOREIGN BODY REACTION, LOSS OF RANGE OF MOTION, KNEE SWELLING, NIGHT SWEATS, SCAR TISSUE FORMATION, AND TWO FALLS. THE INFECTION REQUIRED INTRAVENOUS ANTIBIOTICS, AND ALLERGY TESTING CONFIRMED SENSITIVITY TO NICKEL. THE PATIENT CONTINUES TO EXPERIENCE SIGNIFICANT PAIN AND HAS A REVISION PLANNED FOR THE RIGHT KNEE, WITH NO PLANS FOR THE LEFT KNEE AT THIS TIME. THE IMPLANT REMAINS IN SITU.

  Patient problems: Adhesion(s); Distress; Fall; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Swelling/ Edema; Unspecified Infection

  MAUDE report 24517788 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY. NO OTHER INFORMATION IS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24081129 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S SOFT TISSUES BECAUSE LAX. HAD TO REVISE THE FEMUR AND POLY. DOI- (B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23510995 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISIONS DUE TO INSTABILITY AND PAIN. SURGEON DECIDED TO RESURFACE AN UN RESURFACED PATELLA. MAYBE DUE TO UNRESURFACED PATELLA, ALSO DECIDED TO INCREASE CONSTRAINT LEVEL TO HELP WITH STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23008976 ↗
• InjuryJul 8, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2025, THE PATIENT HAD A LEFT TOTAL REVISION TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT WITH DEBONDING OF THE CEMENT, MEDICAL POLYETHYLENE WEAR WITH SOME OSTEOLYSIS, MILD MID FLEXION INSTABILITY WITH EXTERNAL ROTATION OF THE FEMORAL COMPONENT. THE INDICATIONS FOR SURGERY INCLUDE PAIN. DOI: (B)(6) 2016, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22440784 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT INFECTED AND THE SURGEON REMOVED THE IMPLANTS TO DO A SPACER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22243477 ↗
• InjuryMay 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AND FEMUR AT CEMENT TO IMPLANT INTERFACE. THERE WAS NO PATIENT HARM OR CONSEQUENCES RELATED TO THE EVENT. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22055714 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT RECEIVED A SECOND LEFT KNEE REVISION TO TREAT PERSISTENT GLOBAL INSTABILITY. THE PATIENT HAD A PREVIOUS REVISION OF THE TIBIAL INSERT TO TREAT INSTABILITY AND POLY-WEAR ON (B)(6) 2018 ((B)(4)) UPON ENTERING THE JOINT, THE SURGEON NOTED THE TIBIAL TRAY WAS STABLE BUT MILDLY LOOSENED AT THE SMART-SET CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS STABLE BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED UNKNOWN TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A DEPUY ATTUNE STEMMED REVISION CONSTRUCT SECURED WITH COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2018. DOR (B)(6) 2018 (PRIMARY TIBIAL INSERT CAPTURED ON (B)(4)). DOR: (B)(6) 2023 (UNK INSERT, FEMORAL, TRAY, CEMENT). LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21201123 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAINFUL LEFT KNEE AND UNDERWENT REVISION KNEE SURGERY AND REMOVAL OF HARDWARE WITH HINGE KNEE REPLACEMENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21094960 ↗
• InjurySep 30, 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: DID SUBJECT REPORT ANY NEW AES OR ANY UPDATES TO AN EXISTING AE AT THIS EVALUATION?: YES. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: KNEE; NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO REMOVAL/EXCHANGE/REVISION. ADDITIONAL EVENT INFORMATION. CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: (B)(6) 2019. DATE OF IMPLANT: (B)(6) 2019 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT KNEE. TREATMENT/IMPACT: ASPIRATION/DRAINAGE; RECOVERED/RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2019.

  Patient problems: Swelling/ Edema

  MAUDE report 20332925 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION: DEVICE (RELATEDNESS): POSSIBLY. PROCEDURE (RELATEDNESS): POSSIBLY. DATE OF EVENT: 29 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: BLANK. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 20293203 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY VIA TKA. AFTER THE SURGERY, UNKNOWN DEFECT OCCURRED. WE ARE CONFIRMING ABOUT DETAILS. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL EVENT INFORMATION THE PATIENT UNDERWENT A REMOVAL SURGERY DUE TO INFECTION ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20145557 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A KNEE REPLACEMENT AND IS EXPERIENCING PAIN ON THE SIDE OF HER KNEE WHEN GOING UP AND DOWN THE STAIRS. PATIENT REPORTS INSTABILITY WHEN WALKING AND HAS FALLEN A FEW TIMES. PATIENT FEELS WARMTH AND THE KNEE GETS HEAVIER AT NIGHT AND OFTEN TIMES HARD TO BEND. THE CT WITHOUT CONTRASTS DIDN'T SHOW ANYTHING IN THE SCAN. PATIENT EXCLAIMED SHE HAD SURGERY ON HER RIGHT KNEE 22 YEARS AGO WITH NO ISSUES. DOI: UNKNOWN DOR: UNKNOWN AFFECTED SIDE: UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 20085173 ↗
• InjuryAug 22, 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. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20030146 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APRIL 30, 2024, THE SALES REP WAS INFORMED THAT THE IMPLANT WAS SCHEDULED TO BE REMOVED DUE TO INFECTION. HE ALSO RECEIVED A REQUEST TO ARRANGE FOR A SET OF EXTRACTION INSTRUMENTS. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2017. DOE: PENDING.

  Patient problems: Unspecified Infection

  MAUDE report 19310806 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2013 DATE OF EVENT: (B)(6) 2016 (LEFT KNEE) TREATMENT: PHYSICAL THERAPY

  Patient problems: Muscular Rigidity

  MAUDE report 19220585 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON EXPLANTED THE IMPLANTS. DOI: (B)(6) 2022. DOR: (B(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18960332 ↗
• InjuryMar 5, 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 MEDIAL EPICONDYLE FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 18836289 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THEY WERE DOING AN EXPLANT OF COMPONENTS AND PUTTING IN AN ANTIBIOTIC SPACER. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18611068 ↗
• InjuryJan 8, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  SUBJECT ID: (B)(6); STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING OF TIBIAL. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2017, DATE OF EVENT: (B)(6) 2023, DATE OF REVISION: (B)(6) 2023, (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Osteolysis; Synovitis; Unspecified Tissue Injury

  MAUDE report 18465555 ↗
• InjuryDec 20, 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 ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6). 2023 DATE OF EVENT: 07 DEC 2023 (LEFT KNEE) TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 18363863 ↗
• InjuryDec 6, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH ATTUNE IMPLANTS. AFTER THE SURGERY, ALTHOUGH THE PATIENT HAD NO SYMPTOMS, X-RAYS REVEALED LOOSENING OF HIS/HER FEMUR AND TIBIA. ON (B)(6) 2023, THE PATIENT WILL UNDERGO A REVISION SURGERY. THE CAUSE OF LOOSENING IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18274182 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION DUE TO PAIN AND STIFFNESS. THE PATIENT'S KNEE WAS REVISED UNEVENTFULLY AND NO PATIENT HARM OCCURRED. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 17351318 ↗