ATTUNE 1517-10-506Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295055907), received between Jan 23, 2019 and Sep 25, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50904664 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD KNEE INSTABILITY. INSERT WAS UPSIZED. NO DELAYS OR ISSUES WITH IMPLANTS. DOI: (B)(6) 2021, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24911265 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 24260088 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CRS FEMORAL RT SZ 5 CEM, ATUNE PRESSFIT STR STEM12X60MM, ATTUNE CEMENTED STEM 14X50MM, ATTUNE CRS RP INSRT SZ 5 6MM, ATUNE REV RP TIB BASE SZ 4 CEM, ATUN TIB SLV M/L 29MM HALF POR, AND ATTUNE MEDIAL ANAT PAT 32MM WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A REVISION OF A PREVIOUS ATTUNE REVISION PROCEDURE, WITH THE REASON FOR REVISION BEING INFECTION. THE SURGEON SUSPECTED INFECTION AT THE TIME OF IMPLANTATION DUE TO POOR INGROWTH IN THE TIBIAL SLEEVE AND NOTED THAT THE CEMENTED FEMORAL STEM WAS EASILY REMOVED. THE EVENT WAS ASSOCIATED WITH THE RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23862815 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22853004 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER WAS CHANGED TO RULE OUT INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 20746452 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A POLY SWAP; PERFORMED IRRIGATION AND DEBRIDEMENT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582423 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS SWAPPED DUE TO INFECTION. DOI: UNKNOWN. DOR:(B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20016258 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19166809 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO RULE OUT INFECTION. THERE WAS NO DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19164928 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR WASHOUT DUE TO INFECTION. THE POLY WAS CHANGED AFTER THE WASHOUT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18993074 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS CONFIRMED THAT THERE WERE NO DEPUY IMPLANTS INVOLVED IN ANY OF THE PRIOR OPERATIONS AS A REVISION TKA WAS PLACED. PRIMARY SURGERY WAS WITH COMPETITIVE PRODUCTS AND NOT DEPUY.

  Patient problems: Wound Dehiscence

  MAUDE report 18992335 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY ? NO SURGICAL DELAY. B. WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. RIGHT KNEE REVISION. PATIENT HAD DEHISCED FOLLOWING INITIAL REVISION AND HAD TO BE WASHED OUT WITH POLY SWAP.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 18978859 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN IF THERE IS LOOSENING. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16843250 ↗
• InjuryDec 27, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A TKA SURGERY FOR RA. TRIAL OF THE IMPLANTS WAS DONE AND IMPLANTATION OF PRODUCTS WAS FINISHED GOOD, SO THE SURGEON STARTED WOUND CLOSURE. THERE WAS NO SURGICAL DELAY. BUT IT WAS FOUND THAT THE INSERT IN QUESTION SPUN-OUT BY AN X-RAY TAKEN JUST AFTER THE CLOSURE. SUBSEQUENTLY, THE SURGEON PERFORMED A REVISION SURGERY TO EXCHANGE THE INSERT IN QUESTION (CRS6MM) TO A NEW ONE (CRS10MM). NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, UNK KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16052395 ↗
• InjuryApr 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Joint Dislocation; Joint Laxity; Pain; Unspecified Musculoskeletal problem

  MAUDE report 14239732 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS, PAIN, EFFUSION AND DECREASED RANGE OF MOTION. THE SURGEON INDICATED THE PATIENT WILL GO BACK INTO PHYSICIAN THERAPY AND UNDERGO A REVISION PROCEDURE AFTER STRENGTHENING THE LEFT SIDE. THERE IS NO EVIDENCE OF REVISION.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12474787 ↗
• InjuryJul 15, 2021Adverse 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) 2021, RIGHT KNEE.

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

  MAUDE report 12175762 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS STIFF SO SURGEON REMOVED POLY AND CLEANED UP ANY OSTEOPHYTES IN THE BACK OF THE KNEE AND REPLACED WITH A NEW POLY TO HELP WITH RANGE OF MOTION. NO LOOSENING REPORTED. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11758017 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11574162 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON NEEDED TO DO A WASHOUT ON THE PATIENT FOR POSSIBILITY OF INFECTION. SURGEON PERFORMED I&D OF THE KNEE AND POLY EXCHANGE. AFTER THE SURGERY SURGEON INFORMED THAT PATIENT HAD MRSA AND WAS GIVING ANTIBIOTICS. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10870099 ↗
• InjuryJul 1, 2020Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE VIA TKA WITH ANOTHER COMPANY¿S IMPLANTS. AFTER THE PRIMARY SURGERY, THE END OF 2019, THE REMOVAL SURGERY WAS PERFORMED (THE DATE WAS UNKNOWN) BY REMOVING ALL IMPLANTS (THE REASON WAS UNKNOWN). BEGINNING OF THE 2020, THE REVISION SURGERY WAS PERFORMED WITH ANOTHER COMPANY¿S IMPLANTS (THE DATE WAS UNKNOWN), BUT THE INFECTION OCCURRED, AND THE SURGEON SET CEMENT MOLD. ON (B)(6) 2020, THE SURGEON CONFIRMED SUBSIDING OF THE INFECTION, AND THE SECOND REVISION SURGERY WAS PERFORMED BY IMPLANTING DEPUY¿S IMPLANTS. IT WAS REPORTED THAT THE DISLOCATION OF THE TIBIAL INSERT (P/N: 151710506) OCCURRED ON (B)(6) 2020. THE EMERGENCY THIRD REVISION SURGERY WAS PLANNED ON (B)(6) 2020 BY REPLACING THE TIBIAL INSERT. THE SURGEON THOUGHT THAT THE DISLOCATION OF THE TIBIAL INSERT WAS CAUSED BY THE PATIENT¿S THE RHEUMATICS, HIS MUSCLE AND TISSUE¿S ATROPHY AND INSERTING THIN TIBIAL INSERT. THE SURGEON FOUND THE PATIENT¿S ATROPHY IN THE SECOND REVISION SURGERY ON (B)(6) 2020. AND, HE THOUGHT THAT IMPLANTING THIN TIBIAL INSERT BROUGHT RAPID LOOSENING OF THE PATIENT¿S MUSCLE AND TISSUE, AND THE DISLOCATION OF THE TIBIAL INSERT OCCURRED AFTER THE THIRD REV

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10221240 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MANIPULATION, I AND D AND REMOVAL OF SCAR TISSUE WERE PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10061552 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8270502 ↗