ATTUNE AFFIXIUM 1506-21-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295507451), received between Jan 26, 2023 and Jun 4, 2026 — classified as 27 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 12, 2024Class IIOpen, Classified

   Product incorrectly labelled.

   Z-1456-2024 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO THE FEMORAL COMPONENT DISLODGING AND ROTATING ANTERIORLY, THE KNEE WAS REVISED IN ITS ENTIRETY. THE FEMORAL COMPONENT, TIBIAL COMPONENT AS WELL AS POLY INSERT WERE REMOVED FROM THE PT. AND FIELD, THERE WAS NO DELAY TO THE CASE NOR HARM DONE TO THE PATIENT. THERE WAS AN ATTEMPT TO SALVAGE THE PRIMARY CONSTRUCT, BUT THERE WAS NO WAY TO RECONSTRUCT THE FEMUR PROPERLY. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25394908 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALLING AFTER TOTAL KNEE REPLACEMENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 25354687 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS. 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: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL). DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 150401206. LOT NUMBER: 4035479. COMPONENT TYPE: FEMORAL. DESCRIPTION: ATTUNE CR FEM RT SZ 6 POR. CATALOG NUMBER: 150621006. LOT NUMBER: JA06A1468. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB TIB BASE SZ 6 POR. CATALOG NUMBER: 152020606. LOT NUMBER: M5345X. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 6 6MM. CATALOG NUMBER: 3322020. LOT NUMBER: 4513647. COMPONENT TYPE: CEMENT. DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 25045196 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2026. (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: ARTHROFIBROSIS/PAIN.

  Patient problems: Arthrofibrosis; Pain

  MAUDE report 24944595 ↗
• InjuryMar 6, 2026Osseointegration Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING, DATE OF EVENT: FEBRUARY 9,2026, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2026, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: TREATMENT/IMPACT: COMPONENTS REMOVED. (FEMORAL, TIBIAL, AND INSERT) DEPUY SYNTHES PRODUCTS USED: NO INFORMATION PROVIDED. CATALOG NUMBER: 150401206 LOT NUMBER: 4794037 COMPONENT TYPE: FEMORAL DESCRIPTION: ATTUNE CR FEM RT SZ 6 POR. CATALOG NUMBER: 150621006 LOT NUMBER: JA06A0524 COMPONENT TYPE: TIBIAL DESCRIPTION: ATTUNE FB TIB BASE SZ 6 POR. CATALOG NUMBER: 152020606 LOT NUMBER: M8975U COMPONENT TYPE: INSERT DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 6 6MM. CONCOMITANT PRODUCTS INVOLVED: CATALOG NUMBER: UNKNOWN KNEE TROCHLEAR LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: UNKNOWN KNEE PATELLA LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24530166 ↗
• InjuryFeb 25, 2026Fracture; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO POSSIBLE BROKEN PEG ON AFFIXIUM BASEPLATE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24444003 ↗
• InjuryJan 30, 2026Fracture; Migration

  IT WAS REPORTED THAT TIBIAL COMPONENT SUBSIDED WITH A SMALL FRACTURE OF MEDIAL TIBIA AT NON-CEMENTED INTERFCAE. DOI: (B)(6) 2025. DOR: (B)(6) 2026 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24221709 ↗
• InjuryJan 7, 2026Use of Device Problem

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON REMOVED THE PATIENT'S PRIMARY PRESS-FIT TIBIAL TRAY AND INSERT. HE THEN RECUT THE PATIENT'S PROXIMAL TIBIA, VARYING SLIGHTLY THE INITIAL VARUS VALGUS ANGLE AND POSTERIOR SLOPE. HE THEN IMPLANTED A REPLACEMENT REVISION TIBIAL TRAY, WITH A SHORT CEMENTED STEM AND AUGMENTS ATTACHED, AND A THICKER REPLACEMENT INSERT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23993172 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH STAGE 1 OF 2 REVISION. ANTIBIOTIC SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23879143 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23821673 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STABLE KNEE IN OR AFTER SURGERY. THE PATIENT GOT UP IN RECOVERY AND POPPED SOMETHING. THE PATIENT WAS BROUGHT BACK TO OPERATING ROOM AND IT SEEMED THAT SHE LOST HER POSTERIOR CAPSULE. KNEE WAS EXPLANTED AND RP CRS WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23495526 ↗
• InjurySep 2, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT HAD LOOSE TIBIA. KNEE WAS REVISED TO ADDRESS ASEPTIC IMPLANT LOOSENING AT THE BONE TO IMPLANT INTERFACE AND POSTERIOR COLLAPSE/IMPLANT MIGRATION. THERE WAS POSTERIOR COLLAPSE AND A LOOSENING INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22947777 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE AND SURGEON DECIDED TO EXPLANT AND REVISE ALL COMPONENTS. THERE WAS NO DELAY OR COMPLAINTS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22579750 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. INSTABILITY WAS NOT DUE TO POLY WEAR. PATIENT REPORTED FEELING A CHANGE AND PAIN AFTER DOING WEIGHTED LEG PRESSES IN PHYSICAL THERAPY. BOTH FEMUR AND TIBIA REQUIRED EXTENSIVE USE OF SAW AND OSTEOTOMES TO REMOVE. THERE WAS NO REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY. NO COMPONENTS WERE UNDERSIZED IN THE PRIMARY SURGERY. THE FEMUR OR TIBIA WERE NOT EXCESSIVELY RESECTED/HAD JOINT LINE RAISED DURING THE PRIMARY SURGERY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22529437 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED PRIMARY KNEE AND SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH FUNCTIONAL SPACER. THERE WERE NO COMPLAINTS OR DELAYS. IMPLANTS WERE NOT BEING RETURNED. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22140656 ↗
• InjuryMar 20, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT PATIENT HAD TIBIA SUBSIDE INTO VARUS AFTER TKA. THERE WAS LOOSENING OF TIBIA AT NON CEMENTED INTERFACE. TIBIA AND POLY WERE EXPLANTED. RP REV TIBIA WITH CONE WAS IMPLANTED WITH AN RPCR POLY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21651365 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY EXPLANTED THE INFECTED KNEE, WITH THE PLACEMENT OF ANTIBIOTIC SPACER. THERE WERE NO ADVERSE CONSEQUENCES OR DELAYS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21527850 ↗
• InjuryFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER INCISION WAS MADE, THE FB INSERT WAS FOUND NOT TO BE ENGAGED ON THE TIBIAL TRAY. A NEW INSERT WAS IMPLANTED. THIS ISSUE WAS IDENTIFIED VIA POST-OP X-RAY. THE PATIENT WAS NOT EXPERIENCING ANY ADVERSE CONDITIONS FROM THE PRIMARY SURGERY, BUT A POLY SWAP WAS DONE TO ENSURE THE COMPONENT WAS PROPERLY SEATED. NO SURGICAL DELAYS WERE INCURRED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21420753 ↗
• InjuryJan 16, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN POST OP AFTER INITIAL TKA IN (B)(6) 2024. TIBIA LOOSENING OCCURRED. REVISION NECESSARY OF TIBIAL COMPONENT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21170566 ↗
• InjuryJan 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT AFFIXIUM TIBIA WAS LOOSE ON X RAY AND THIS WAS CONFIRMED DURING CASE. LOOSENING WAS PRESENT AT NON-CEMENTED INTERFACE. REVISION WAS PERFORMED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21079933 ↗
• InjuryNov 19, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. SURGEON PERFORMED A LTK ON THIS PATIENT THE DAY BEFORE THE ISSUE AROSE. THIS PATIENT HAD A FRACTURE OF HIS THE TIBIA. SURGEON SAW THE FRACTURE ON THE PATIENT'S POST OP X-RAYS. SURGEON ELECTED TO TAKE THE PATIENT BACK TO SURGERY THE FOLLOWING DAY. SURGEON WENT IN AND REMOVED THE TIBIAL INSERT AND TIBIAL TRAY. ONCE THE PREVIOUS IMPLANTS WERE REMOVED, THE FRACTURE WAS STABLE AND NONDISPLACED. SURGEON THEN CHOOSE TO USE A STEMMED TIBIAL COMPONENT BYPASSING THE FRACTURE SITE. THE NEW COMPONENTS WERE CEMENTED INTO PLACE ADDING TO IMMEDIATE STABILITY OF THE COMPONENT. A NEW INSERT WAS CHOSEN TO COMPLETE THE STABILITY OF THE KNEE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 20724676 ↗
• InjuryJul 19, 2024Migration; Migration

  IT WAS REPORTED THAT THE TIBIA SUBSIDED. DOI: (B)(6), 2023 DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19782278 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POOR RANGE OF MOTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19343534 ↗
• InjuryApr 16, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY DONE ON (B)(6) 2023. PATIENTS TIBIA SUBSIDED. A REVISION FB TRAY WAS PREPARED WITH A 110 REVISION STEM. FEMUR STABILITY WAS CONFIRMED. A RIGHT 12MM MS INSERT WAS TRIALED AND FOUND TO BE STABLE. REAL IMPLANTS WERE OPENED AND IMPLANTED. NO ADVERSE EVENTS OR SURGICAL DELAYS TOOK PLACE. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19118119 ↗
• MalfunctionMar 27, 2024Wrong Label; Wrong Label

  ADDITIONAL INFORMATION WAS RECEIVED: -CONFIRMED THEY ORDERED THE PRODUCT BASED ON THE BOX NOT ON THE INCORRECT LABEL. -SO THEY ORDERED A SIZE 6 AFFIXIUM BASEPLATE NOT THE STICKER WHICH WAS A SIZE 5. ANOTHER ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY ? NO. B. WHAT WAS THE EVENT DATE ? MARCH 19. C. WHAT WAS THE ALLEGATION AGAINST THE PRODUCT ATTUNE FB TIB BASE SZ 6 POR. WRONG STICKER SIZE IN BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989140 ↗