ATTUNE AFFIXIUM 1506-21-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295507413), received between Jan 19, 2023 and Sep 29, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Osseointegration Problem

  It was reported that Surgeon revised tibia. Tibia was loose and loosening interface was bone to implant (Non-Cemented).Affected Side: Left knee.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50934712 ↗
• InjurySep 28, 2026Migration

  It was reported that the patient fell one day after these were implanted. The tibia subsided.Affected side: Right.

  Patient problems: Fall

  MAUDE report 50913539 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient fell after original total knee arthroplasty, followed by a broken patella, surgical fixation of the patella, development of infection, and removal and replacement of all components except the patella was done. A SureSpace spacer was implanted. DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Left Knee.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 50310796 ↗
• InjuryAug 3, 2026Loss of or Failure to Bond

  Patient problems: Insufficient Information

  MAUDE report 50117827 ↗
• InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 25903771 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPRESSED DISCOMFORT AND PAIN IN THE TIBIA. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 25190986 ↗
• InjuryMay 5, 2026Osseointegration Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION. DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 150401104. LOT NUMBER: 3793392.. COMPONENT TYPE: FEMORAL DESCRIPTION: ATTUNE CR FEM LT SZ 4 POR. CATALOG NUMBER: 150621004. LOT NUMBER: JA04A0460. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB TIB BASE SZ 4 POR. CATALOG NUMBER: 151820406. LOT NUMBER: M83K02. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 4 6MM. CATALOG NUMBER: 151810035 LOT NUMBER: 4689234. COMPONENT TYPE: PATEL.AR. DESCRIPTION: ATTUNE MEDIAL ANAT PAT 35MM. CATALOG NUMBER: 3322020. LOT NUMBER: 4494872. COMPONENT TYPE: PATELLAR. DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25081152 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION TO TREAT INSTABILITY AND PAIN. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24926094 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED DUE TO INFECTION. STAGE 1 OF 2 KNEE REVISION WAS PERFORMED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24874685 ↗
• InjuryNov 17, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE PAIN, BILATERALLY, AFTER BILATERAL KNEE REPLACEMENT. AFXM TIBIAS WERE LOOSE AT BONE TO IMPLANT(NON-CEMENTED) INTERFACE. PATIENT WAS REVISED TO RP REV TIBIAS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23571661 ↗
• InjuryNov 14, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE PAIN, BILATERALLY, AFTER BILATERAL KNEE REPLACEMENT. AFXM TIBIAS WERE LOOSE AT THE BONE TO IMPLANT INTERFACE. REVISED TO RP REV TIBIAS. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23559997 ↗
• InjuryAug 5, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT LOOSENING OF REPORTED PRODUCT. LOOSING INTERFACE UNKNOWN. CEMENT MANUFACTURER UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22717189 ↗
• InjuryMay 2, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISED TIBIAL TRAY AND POLY DUE TO TIBIAL TRAY SUBSIDENCE. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21953136 ↗
• InjuryMar 25, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT WANTED TO COMPLAIN THAT THE IMPLANT WAS NOT WORKING AT ALL.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Fall; Fatigue; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21686426 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN AND INSTABILITY. INSTABILITY WAS NOT RELATED TO POLY WEAR. NO REPORTED MALPOSITION OF COMPONENTS. INSERT MAY HAVE BEEN UNDERSIZED, WENT TO A 12 MM INSERT IN THE REVISION. JOINT LINE NOT RAISED IN PRIMARY SURGERY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21462672 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAINFUL TOTAL KNEE ARTHROPLASTY (TKA). DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 20750700 ↗
• InjuryJul 12, 2024Migration; Migration

  IT WAS REPORTED THAT AFTER THE PRIMARY KNEE REPLACEMENT, THE TIBIAL BASEPLATE SUBSIDED ANTERIORLY AND SURGEON DECIDED TO REPLACE THE FEMORAL COMPONENT AS WELL WITH CRS COMPONENTS. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19728242 ↗
• MalfunctionOct 11, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A TKA FOR OA OF THE KNEE JOINT. THE TIBIAL TRAY IN QUESTION WAS USED IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. POSTOPERATIVE X-RAY SHOWED POSTERIOR IMPLANT WAS FLOATING. ACCORDING TO THE SURGEON, IT WAS INSTALLED ALL AROUND THE CIRCUMFERENCE AT THE TIME OF INSERTION. THEN, THE SURGEON COMMENTED THAT THE POSTERIOR PART WAS NOT INSTALLED PROPERLY. THE ANTERIOR TIBIA MIGHT HAVE CRACKED. THE SURGEON GUESSED THAT AN UNEXPECTED LOAD MIGHT BE APPLIED WHEN AN UNFAMILIAR FB INSERT WAS HAMMERED AND INSERTED. IT MIGHT HAVE CAUSED THE ISSUE. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17916294 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA COMPLETED ON (B)(6) 2023.

  Patient problems: Adhesion(s)

  MAUDE report 16205284 ↗