ATTUNE AFFIXIUM 1506-21-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295507468), received between Dec 8, 2022 and Aug 7, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Use of Device Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to malpositioning of unknown component(s) and pain.

  Patient problems: Pain

  MAUDE report 50180130 ↗
• InjuryFeb 25, 2026Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED PROVIDING ANSWERS FROM THE FOLLOWING QUESTIONS: PLEASE CONFIRM WHY THE FEMORAL COMPONENT WAS REPLACED AND IF THERE WAS A MALFUNCTION? THE FEMORAL COMPONENT WAS REPLACED BECAUSE THE TIBIA WAS INACCESSIBLE DURING THE REVISION. THE SURGEON WAS UNABLE TO REVISE THE TIBIA WITHOUT ALSO REMOVING THE FEMORAL COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 24442581 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24413409 ↗
• InjuryJan 8, 2026Osseointegration Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150401107, LOT NUMBER: 4710696, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE CR FEM LT SZ 7 POR, CATALOG NUMBER: 150621007, LOT NUMBER: 4473918, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB TIB BASE SZ 7 POR, CATALOG NUMBER: 151820706, LOT NUMBER: M90N29, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 7 6MM, CONCOMITANT PRODUCT: CATALOG NUMBER: 151811038, LOT NUMBER: 355797, COMPONENT TYPE: PATELLA, DESCRIPTION: ATT MED ANAT PAT 38MM POR.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24008290 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PLACED. THERE WERE NO DELAYS OR PATIENT INJURY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23560218 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) 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 PAIN.

  Patient problems: Pain

  MAUDE report 23467276 ↗
• InjuryOct 23, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT GOT A PRESSFIT TOTAL KNEE (B)(6) 2024 AND WENT ON A CRUISE IN (B)(6) AND WAS WALKING 10K STEPS A DAY THEN REPORTED DISCOMFORT IN THE TIBIA REGION. SURGEON MENTIONED THAT THE DISTAL TIBIAL KEEL SHOWED MICROMOTION AND SCLEROTIC BONE. UPON REMOVAL HE NOTICED THE SCLEROTIC BONE IN THAT DISTAL TIP. FULL REVISION WAS THE RESULT. DOI: (B)(6) 2024 . DOR: (B)(6)2025 . AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching; Discomfort; Inadequate Osseointegration

  MAUDE report 23374267 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED AND IMPLANTED FOR INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23040264 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED TO TREAT INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22848378 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE AFTER PRIMARY KNEE AND SURGEON REVISED TIBIA. THERE WERE NO COMPLAINTS OR DELAYS AND NO HARM TO THE PATIENT. IMPLANTS UNAVAILABLE FOR RETURN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 22677131 ↗
• InjuryJul 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2025. THE PATIENT FELL AND COMPLAINED ABOUT HIS KNEE HURTING. THE PATIENT HAD DAMAGED HIS TIBIA WHICH CAUSED THE TIBIA IMPLANT TO LOOSEN. THE DOCTOR DECIDED THAT A FULL KNEE REVISION KNEE WAS NEEDED FOR STABILITY.

  Patient problems: Bone Notching; Fall; Joint Laxity; Pain

  MAUDE report 22456962 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK FOR A REVISION DUE TO LIMITED RANGE OF MOTION FROM HIS TOTAL KNEE. ALL COMPONENTS, BESIDES PATELLA WERE REMOVED AND A CRS RP REVISION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22031692 ↗
• InjuryMar 20, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD KNEE PAIN AFTER SURGERY. TIBIA DID NOT APPEAR LOOSE ON X-RAY. DURING REVISION IT WAS FOUND TO BE NOT INGROWN AND LOOSE. TIBIA WAS REVISED TO RP REV W STEM AND RPCR POLY WAS IMPLANTED. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21652713 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE HAVE BEEN 3 REVISIONS IN THE ATTUNE MS COHORT. 1 EACH FOR INFECTION, INSTABILITY, AND ASEPTIC MECHANICAL LOOSENING. ATTUNE MS REVISION RATE AT INSTITUTION IS (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 21354418 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS: CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION-DEEP / POSSIBLE INFECTION SEEDED FROM SINUS INFFECTION. DEVICE RELATEDNESS: POSSIBLY. PROCEDURE RELATEDNESS: DEFINITELY NOT. DATE OF EVENT: 22/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 20914198 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Pain

  MAUDE report 20853063 ↗
• InjuryOct 28, 2024Adverse 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 A STITCH REACTION. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: REMOTE POSSIBILITY. DATE OF EVENT: 26-SEP-2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: THE PATIENT WAS SEEN FOR FOLLOW-UP, POST KNEE ARTHROPLASTY BY THREE WEEKS. THE PATIENT HAS A LOCALIZED SUTURE REACTION. THERE HAS BEEN PUS DRAINING OUT OF THE AREA. THE AREA WAS CLEANED AND DEBRIDED AND PLACED ON ORAL ANTIBIOTICS. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 151820041. LOT NUMBER: 4534213. COMPONENT TYPE: PATELLAR. DESCRIPTION: ATTUNE MEDIAL DOME PAT 41MM. CATALOG NUMBER: 150401207. LOT NUMBER: 4513837. COMPONENT TYPE: FEMORAL. DESCRIPTION: ATTUNE CR FEM RT SZ 7 POR. CATALOG NUMBER: 152020708. LOT NUMBER: M5164N. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 7 8MM. CATALOG NUMBER: 150621007. LOT NUMBER: 4461808. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB TIB BASE SZ 7 POR. CATALOG NUMBER: 3322020. LOT NUMBER: 4389262. COMPONENT TYPE: CEMENT. DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Fluid Discharge; Hypersensitivity/Allergic reaction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20543573 ↗
• InjuryAug 6, 2024Migration; Migration

  IT WAS REPORTED THAT DURING THE TOTAL KNEE ARTHROPLASTY THE SURGEON IMPLANTED A SIZE 7 AFFIXIUM TIBIAL TRAY FOLLOWED BY A SIZE 8 CR CEMENTLESS FEMUR. WHEN HE PLACED THE TRIAL MS BEARING AND EXTENDED THE LEG THE TIBIAL TRAY LIFTED OFF THE BONE ANTERIORLY A FEW MILLIMETERS. HE REMOVED THE MS TRIAL AND IMPACTED THE TIBIA TRAY AGAIN, BUT WHEN HE RANGED THE KNEE, THE TIBIAL TRAY LIFTED OFF INTERIORLY AGAIN. HE DID NOT FEEL COMFORTABLE LEAVING IT AS A CEMENTLESS CONSTRUCT SO HE OPTED TO CEMENT IN THE COMPONENTS. DOI: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918400 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 19844719 ↗
• InjuryApr 24, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO SUBSIDENCE OF HIS PRIMARY TIBIAL TRAY. HIS PRIMARY ATTUNE FB CR MEDIAL STABILIZED TIBIAL INSERT AND FB TIBIAL TRAY WERE REMOVED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19174118 ↗
• InjuryDec 20, 2023Use of Device Problem; Use of Device Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO MALPOSITION/MALALIGNMENT. DATE OF IMPLANT: ON (B)(6) 2023. DATE OF REVISION: ON (B)(6) 2023. (LEFT KNEE) TREATMENT: TIBIAL COMPONENT REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18362728 ↗
• InjuryAug 14, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO TIBIAL TRAY COLLAPSED ON THE MEDIAL SIDE. BONE QUALITY WAS POOR. DOI: (B)(6), 2022, DOR: (B)(6), 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 17540063 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GI BLEED. 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: (B)(6) 2023, (LEFT KNEE). TREATMENT: BLOOD GIVEN; PANTOPRAZOLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16815258 ↗
• InjuryMar 9, 2023Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE FEMUR AND TIBIA AT THE BONE TO IMPLANT INTERFACE. PATIENT HAS A PERI PROSTHETIC JOINT INFECTION AND A STAGE 1 ANTIBIOTIC SPACER WAS IMPLANTED. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16512344 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED TOTAL KNEE AFTER APPROXIMATELY 3-4 WEEKS. SURGEON REMOVED PRESSFIT FEMUR AND TIBIA AND AOX INSERT. THE SURGEON PERFORMED AND IRRIGATION AND DEBRIDEMENT AND CEMENTED IN A PS FEMUR AND ALL POLY STABILIZED INSERT. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15942443 ↗