ATTUNE AFFIXIUM 1506-21-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295507420), received between Dec 1, 2022 and Sep 28, 2026 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (7 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 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50915293 ↗
• InjuryApr 28, 2026Migration

  IT WAS REPORTED THAT ATTUNE PRESSFIT TIBIA WAS REMOVED DUE TO MEDIAL SIDE SUBSIDING. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25019172 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE FEM POR CR LT SZ 4, ATTUNE FB TIB BASE SZ 5 POR, AND ATUNE CR LT MS INS SZ 4 5 WERE INVOLVED IN A REPORTED EVENT. FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION, WHICH NECESSITATED IRRIGATION AND DEBRIDEMENT. SUBSEQUENTLY, A REMOVAL SURGERY WAS PERFORMED, AND ALL IMPLANT COMPONENTS WERE EXTRACTED DUE TO UNCONTROLLABLE INFECTION. CEMENT MOLDING WAS COMPLETED SUCCESSFULLY DURING THE REVISION PROCEDURE. THIS PC IS RELATED TO (B)(6) , WHICH REPORTS ON THE POSTOPERATIVE INFECTION AND THE DEBRIDEMENT. THIS PC REPORTS ON THE REMOVAL SURGERY AFTER THE DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 24814998 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF EXTREME TIBIAL PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24647620 ↗
• InjuryFeb 19, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE BONE TO IMPLANT INTERFACE. ASEPTIC LOOSENING OF A LEFT TOTAL KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24387788 ↗
• InjuryFeb 17, 2026Migration

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? ORIGIAL SURGERY DATE (B)(6) 2025. B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT KNEE. C. PLEASE CONFIRM IF THERE IS ANY ALLEGATION AGAINST THE KNEE TIBIAL INSERT? NO ALLEGATION AGAINST INSERT.

  Patient problems: Insufficient Information

  MAUDE report 24365100 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED TOTAL KNEE. SURGEON TOOK OUT OLD PARTS AND PUT IN A SPACER. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24114404 ↗
• InjuryJan 16, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE AFFIXIUM TRAY AT THE BONE TO IMPLANT INTERFACE. TIBIAL IMPLANTS EXPLANTED AND REVISED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24096756 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA, FEMUR, AND POLY INSERT WERE REMOVED DUE TO A METAL ALLERGY. THERE WAS NO DELAY TO THE CASE AFTER EXPLANTATION AND ALL PIECES WERE REMOVED FROM THE FIELD IMMEDIATELY. THERE WAS NO HARM DONE TO THE PATIENT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23750819 ↗
• InjuryNov 6, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23486461 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23465236 ↗
• InjurySep 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMUR AND TIBIA LOOSENING AT UNKNOWN INTERFACE. PATIENT REPORTED PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22955694 ↗
• InjuryAug 5, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE ATTUNE TIBIAL TRAY WAS REVISED FOR LOOSENING AT AN UNKNOWN INTERFACE.

  Patient problems: Insufficient Information

  MAUDE report 22716030 ↗
• MalfunctionMay 1, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKAGING ON BOTH LAYERS WAS NOT SEALED. BOTH THE INNER PACKAGES WERE COMPROMISED. DID NOT USE THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944306 ↗
• InjuryMar 25, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT WAS REVISED DUE TO MALPOSITIONED TIBIA. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21687269 ↗
• InjuryFeb 4, 2025Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem

  IT WAS REPORTED THAT THERE HAVE BEEN 3 REVISIONS IN THE ATTUNE MS COHORT. ONE EACH FOR INFECTION, INSTABILITY, AND ASEPTIC MECHANICAL LOOSENING. ATTUNE MS REVISION RATE AT INSTITUTION IS 0.4%.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 21302649 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID:(B)(6). STUDY NO: DOTS. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR THE RIGHT KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: POSSIBLY DATE OF EVENT: 19/SEP/24 . TREATMENT/IMPACT: :NO INFORMATION PROVIDED.

  Patient problems: Cardiogenic Shock; Cardiovascular Dysfunction/Insufficiency; Low Blood Pressure/ Hypotension; Pulmonary Embolism

  MAUDE report 20438879 ↗
• InjuryJul 26, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE ATTUNE PRIMARY CR KNEE WITH AFFIXIUM TIBIA WAS REMOVED FOR TIBIAL PAIN AND SUSPECTED LACK OF TIBIAL INGROWTH. REMOVED TIBIA WAS DESCRIBED AS ¿PARTIALLY INGROWN¿. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19839000 ↗
• MalfunctionApr 4, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT WHEN THE ITEM WAS OPENED (BOX READS SZ 5 AFFIXIUM 1506-21-005) LOT??? THE STICKER INSIDE BOX READS SZ 6 (1506-21-006) LOT JA06A0954.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043188 ↗
• InjuryApr 4, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT COMPLAINED ABOUT KNEE PAIN, SURGEON OBSERVED THE TIBIA DID NOT FULLY INGROW AND SUBSIDED AND DECIDED TO REVISE TIBIA TO REVISION BASEPLATE. THERE WERE NO OTHER COMPLAINTS AND NO DELAY IN PROCEDURE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19042427 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF (B)(6) 2023. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: TIBIA WAS REVISED - WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Joint Laxity

  MAUDE report 18669210 ↗
• InjuryFeb 6, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED DUE TO MALALIGNMENT AND PRIMARY ATTUNE TIBIAL INSERT AND TIBIAL TRAY WERE REMOVED, AND TIBIA WAS THEN RECUT TO CORRECT THE MALALIGNMENT. A REPLACEMENT TIBIAL INSERT, AND AN ATTUNE REVISION TIBIAL TRAY WITH AUGMENTS AND A SHORT CEMENTED STEM, WERE THEN IMPLANTED. PATIENT'S PATELLA WAS ALSO RESURFACED, SINCE IT HAD NOT BEEN RESURFACED DURING HIS PRIMARY PROCEDURE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18651879 ↗
• InjuryMay 23, 2023Migration; Migration

  IT WAS REPORTED THAT THE AFXM TIBIA SUBSIDED 2.5 WEEKS AFTER SURGERY. UNSURE IF THERE WAS A FRACTURE ON THE LATERAL TIBIA. CONVERTED TO FB REV TIBIA WITH CEMENTED STEM AND LATERAL AUGMENT. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE : RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16983813 ↗
• InjuryDec 1, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT COMPLAINED OF INCREASING TIBIA PAIN SINCE HAVING LEFT TOTAL KNEE ON (B)(6) 2022. UNKNOWN TRAUMA DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15893150 ↗