ATTUNE 1504-10-126Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10603295041719), received between Aug 8, 2017 and Sep 30, 2026 — classified as 80 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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 81 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was infected, doctor removed all components.Affected side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50947975 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced infection. All components removed. No additional information is available.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left knee.

  Patient problems: Unspecified Infection

  MAUDE report 50042204 ↗
• InjurySep 4, 2025Adverse 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. IMPLANTS WERE REMOVED. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22963964 ↗
• InjuryAug 6, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED: KINDLY CONFIRM IF THERE IS ANY PATIENT CONSEQUENCES DUE TO THIS REPORTED EVENT?

  Patient problems: Insufficient Information

  MAUDE report 22725091 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON IS REVISING DUE TO KNEE PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22321448 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A STAGE 1 KNEE REVISION TO RULE OUT INFECTION. THERE WAS NO SURGICAL DELAY, AND NO SECOND STAGE REVISION WAS PERFORMED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20745585 ↗
• InjuryNov 19, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LATERAL FEMORAL CONDYLE FRACTURED AND COLLAPSED AND THE FEMORAL COMPONENT WAS REVISED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 20723156 ↗
• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT INSTRUMENT WAS FOUND DAMAGED. THE INSTRUMENT PIECE, DURING THE PRACTICE OF MEASURING THE SIZE OF THE FEMUR, THE SPECIALIST DISASSEMBLED, WHICH WHEN PUT ON THE TABLE, ONE PART FELL BEFORE THAN THE OTHER, GIVING NOTICE THAT SOMETHING WAS DAMAGED. DURING THE SURGICAL PROCEDURE, AT THE TIME OF BROACHING, THE IMPLANT FRACTURES. THERE WERE NO ISSUES, NO ALTERATION IN THE ORDER OF THE PROCEDURE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20461497 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INSTABILITY. DOI: (B)(6) 2022. DOR:(B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19615751 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE I&D WAS ALSO DUE TO THE SAME STRAIN OF STAPH AS WAS FOUND ON THE (B)(6) 2024 STAGE 1 REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19483714 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2017 THE PATIENT HAD BILATERAL KNEE ARTHROPLASTIES TO ADDRESS SEVERE PRIMARY OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THESE PROCEDURE, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 (LEFT KNEE STICKER SHEET PAGE 7 OF 16)(RIGHT KNEE STICKER SHEET PAGE 16 OF 16). ON (B)(6) 2023, THE PATIENT HAD A LEFT KNEE REVISION TO ADDRESS THE MECHANICAL FAILURE OF THE PROSTHETIC LEFT KNEE JOINT. DURING THE PROCEDURE, THE SURGEON NOTED THERE WAS A LARGE AMOUNT OF SCAR TISSUE, THERE WAS EXTENSIVE THICKNESS OF THE PATELLA AND IT WAS REMOVED. THERE WAS EVIDENCE OF LOOSENING OF THE TIBIAL TRAY COMPONENT WITH SEPARATION OF THE TIBIAL TRAY FROM THE CEMENT MANTLE. ALL COMPONENTS WERE REMOVED AND COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2017 DOR: (B)(6) 2023 LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 19277484 ↗
• InjuryApr 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA FOR OA FOR THE KNEE JOINT WITH THE IMPLANT IN QUESTION AT THIS HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON APR 18, 2024, THE SALES REP WAS INFORMED THAT THE PATIENT HAD SUFFERED A PATELLA DISLOCATION AT A TRANSFER HOSPITAL. THE PATIENT CAME TO THIS HOSPITAL ON (B)(6) AND THE SURGEON WILL CHECK THE SYMPTOMS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 19213540 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MRR FINDINGS RECEIVED. IT WAS CONFIRMED THAT PATIENT WAS REVISED DUE TO ADDRESS TIBIAL ASEPTIC LOOSENING AND PAIN. THERE WAS A COMPLETE DEBONDING OF THE TIBIAL TRAY TO THE CEMENT MANTLE. DOI: (B)(6) 2016; DOR: (B)(6) 2023; LEFT KNEE.

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

  MAUDE report 19096423 ↗
• InjuryFeb 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LIMITED ROM 60-30-0 TARGET KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: 24 JAN 2024. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Loss of Range of Motion

  MAUDE report 18637005 ↗
• InjuryOct 12, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION FOR POTENTIAL ASEPTIC LOOSENING. KNEE WAS CAUSING PAIN. COMPONENTS APPEARED AT THE TIME TO BE WELL FIXED. ATTUNE SIZE 4 RP PRIMARY TRAY, ATTUNE PS PRIMARY FEMUR. THE FIRST REVISION KNEE WAS DONE ON (B)(6) 2021 CONVERSION FROM PATELLA FEMORAL TO TOTAL KNEE. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 17919447 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROSCROPY UTILIZING DEPUY SYNTHES IMPLANTS INCLUDING SMARTSET BONE CEMENT X 2. THE PATELLA WAS RESURFACED AS WELL. ON (B)(6) 2023 THE PATIENT UNDERWENT A LEFT KNEE REVISION FOR PAIN AND FEELINGS OF INSTABILITY. INTRAOPERATIVELY, HYPERTROPHIC SYNOVIUM WAS IDENTIFIED. THE TIBIAL COMPONENT WAS GROSSLY LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE SURGERY WAS COMPLETED SUCCESSFULLY. DOI: (B)(6) 2017 DOR: (B)(6) 2023 LEFT KNEE.

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 17557787 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16709015 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2012. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 16272703 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI: PATIENT RECEIVED A LEFT PRIMARY ATTUNE TKA TO TREAT SEVERE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: ON AN UNKNOWN DATE THE PATIENT RECEIVED LEFT KNEE A TWO-STAGE REVISION TO TREAT INFECTION. ALL DEPUY PRODUCTS WERE REVISED. THE OPERATIVE NOTES FOR THIS PROCEDURE ARE NOT PROVIDED. DOI: (B)(6) 2016. DOR: UNKNOWN. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15382540 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 14 JUN 2022. LITIGATION DOCUMENT REPORTED THAT THE PLAINTIFF ALLEGES BURSITIS, PAIN, SOMETIMES FELT UNSTABLE, SUFFERING, UNABLE TO WALK FROM THE PARKING LOT TO THE DOOR AND FUNCTIONAL LIMITATION. IT WAS ALSO REPORTED THAT THE PATIENT WAS REVISED DUE TO SEVERE TIBIAL LOOSENING. DOI: (B)(6) 2016, DOR: 2021, LEFT KNEE. THE PATIENT HAS DEPUY BILATERAL KNEE IMPLANTS AND BILATERAL REVISION AS WELL.

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Inflammation; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 14786517 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE REVISION FOR PAIN AND STIFFNESS. DOI: (B)(6) 2020, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 14621635 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. CEMENT MANUFACTURER IS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14468764 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FALLEN A COUPLE OF TIMES OF THE LAST FEW MONTHS AND WAS COMPLAINING OF PAIN AND STIFFNESS. REMOVED THE ATTUNE PRIMARY FEMORAL COMPONENT, ATTUNE TIBIAL COMPONENT AND ATTUNE INSERT. THE PATELLA WAS LEFT. CONVERTED TO A SIGMA TC3 REVISION SYSTEM. DEPUY CEMENT WAS USED. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 14166322 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED KNEE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2022. DOR: (B)(6), 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13869285 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. SURGEON FELT THE KNEE NEEDED A MORE CONSTRAINED IMPLANT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13841339 ↗