ATTUNE 1506-11-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10603295416289), received between Feb 22, 2019 and Jul 27, 2026 — classified as 58 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (25 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Osseointegration Problem

  It was reported that patient underwent an Endo genus dextri (right side) - ATTUNE CEMENTLESS surgery on (b)(6) 2024. After the surgery, they experienced constant pain and had an unsteady gait.According to product specifications, when properly implanted, the components fuse with the bones of the knee within eight weeks. Following examinations and imaging studies, it was determined that the joint components were not in place; the patella was outside the femoral groove of the joint (Patela Bata), and the leg had been displaced to the right and outward.The surgeon recommended physical therapy, but the problem was not resolved. They then recommended operation only on the knee cap. After consultations with other orthopedic surgeons and imaging studies, it was determined that the patella (kneecap) and the joint were not aligned. The joint had been positioned further inward, while the patella was 1 cm to the right and did not fit into the femoral canal. Revision surgery occurred on (b)(6) 2025, fourteen months after initial endoprosthesis replacement. It was determined that osseointegration had not occurred. There was no sign of bone on the implants; they were removed extremely easily, and

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 50037061 ↗
• InjuryJun 26, 2026Osseointegration Problem

  IT WAS REPORTED THAT TIBIA REVISED DUE TO LOOSENING. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25637553 ↗
• 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: PAIN. RETRIEVAL ANALYSIS IDENTIFIED YELLOWING OF THE TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 24942717 ↗
• InjuryMar 5, 2026Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT TIBIAL COMPONENT HAD SUBSIDED AND NEEDED TO BE REVISED WITH A STEM AND AUGMENTS. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24518266 ↗
• InjuryFeb 17, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24369670 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF PAINFUL TKA. BOTH IMPLANTS WERE WELL FIXED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24369474 ↗
• InjuryFeb 5, 2026Migration

  IT WAS REPORTED THAT THE PT TIBIAL TRAY STARTED TO COME UP IN THE POSTERIOR PLATEAU AND SUBSIDED IN THE ANTERIOR PORTION OF THE TIBIA. DR REVISED THE TIBIAL TRAY. NO KNOWN INFECTION WAS PRESENT. NO DELAY IN SURGERY. ALL COMPONENTS WERE RETRIEVED. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24272483 ↗
• InjuryNov 10, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE BONE TO IMPLANT INTERFACE. ASEPTIC LOOSENING PROBABLY FIBROUS INGROWTH DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23511046 ↗
• InjuryNov 7, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF TIBIAL TRAY AT BONE TO IMPLANT INTERFACE. SURGEON EXPLANTED TRAY REVISING WITH ATTUNE REV RP. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23497388 ↗
• InjuryAug 5, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE DOCTOR CHANGED FROM A SIZE 6 CEMENTLESS POROCOAT RP TIBIAL BASE TO A SIZE 6 CEMENTED RP TIBIAL BASE PLATE BECAUSE THE IMPLANT HAD DIRECTIONAL TRANSLATION WITHIN THE TIBIA. THE TIBIA WAS LOOSE. LOOSENING INTERFACE WAS NON-CEMENTED. NO FURTHER INFORMATION IS AVAILABLE. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22719504 ↗
• InjuryMay 7, 2025Osseointegration Problem; Osseointegration Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH 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 AND SLIGHT LOOSENING OF THE TIBIAL COMPONENT. AT REMOVAL THE TIBIAL COMPONENT SHOWED ABUDENT BONE WITH EXCELLENT INTERDIGIGATION. CEMENT MFG IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21979095 ↗
• InjuryMay 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO A LOOSENING TIBIAL IMPLANT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21968280 ↗
• InjuryMar 7, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED AND UNDERWENT TIBIAL REVISION WITH ATTUNE CEMENTLESS RP TRAY LOOSENING. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21548757 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REQUIRED FULL REVISION DUE TO TIBIAL BONE FRACTURE. THE IMPLANT WAS NOT FRACTURED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 20675132 ↗
• MalfunctionNov 7, 2024Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634937 ↗
• MalfunctionAug 22, 2024Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A RIGHT VELYS RAS TOTAL KNEE REPLACEMENT AN ATTUNE TIBIAL BASEPLATE WAS FOUND TO HAVE THE INNER PACKAGING STUCK SOLID WITHIN THE PLASTIC PACKET AND COULD NOT BE OPENED IN A STERILE MANNER. THE SCRUB NURSE MADE SEVERAL ATTEMPTS TO PULL THE INNER PACKAGING OUT FROM THE SOLID PLASTIC BUT IT WAS LOCKED IN TIGHT. A SECOND IMPLANT OF THE SAME SIZE WAS AVAILABLE AND OPENED WITH NO ISSUE. NO DELAY TO SURGERY, NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039125 ↗
• MalfunctionAug 13, 2024Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  UNABLE TO TAKE OUT TIBIAL IMPLANT FROM PACKAGING. PLASTIC PACKAGING WAS DEFORMED/MELTED AND BROKE ON ATTEMPT TO TAKE OUT IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973238 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE TEP SURGERY, RIGHT LEG, ON (B)(6) 2023 AT HOSPITAL. SINCE THEN RASHES AND OTHER INTOLERANCES.

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Swelling/ Edema

  MAUDE report 18749490 ↗
• InjuryFeb 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019 DATE OF EVENT: (B)(6) 2024, (LEFT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA AND ARTHROSCOPY.

  Patient problems: Adhesion(s)

  MAUDE report 18637376 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN ATTUNE TOTAL KNEE REPLACEMENT ON (B)(6) 2023 IN THE SWAH. ON OR AROUND (B)(6) 2023 THEY SUFFERED A DISLOCATED KNEE AND WENT TO THEATRE FOR AN URGENT CLOSED REDUCTION OF DISLOCATED KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 18382781 ↗
• InjuryNov 30, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON NOV 16, 2023, THE PATIENT UNDERWENT A TKA FOR OA FOR THE KNEE JOINT WITH THE IMPLANT IN QUESTION. AFTER SURGERY, THE PATIENT COMPLAINED OF SEVERE PAIN, AND X-RAYS SHOWED A FRACTURE IN THE PROXIMAL TIBIA. CURRENTLY, THE AFFECTED AREA IS IMMOBILIZED WITH A CAST. THE SURGEON MENTIONED THAT HE IS STILL CONSIDERING WHETHER TO REPLACE THE IMPLANT. THE SURGEON ALSO MENTIONED THAT THE FRACTURE WAS LIKELY CAUSED BY THE IMPLANT IN QUESTION BEING PLACED SLIGHTLY BACKWARD, WHICH CAUSED THE CENTER OF THE TRAY TO HIT THE CORTICAL BONE POSTERIORLY, CAUSING THE BONE TO CRACK. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 18236545 ↗
• InjuryOct 2, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND INSTABILITY. THE SURGEON REMOVED THE CEMENTLESS RP TIBIA AND INSERT, REVISING TO A REVISION TIBIA AND CR INSERT. THE TIBIA WAS NOT LOOSE, BUT IT DID NOT APPEAR TO BE FULLY INGROWN. THE IMPLANTS WERE UNAVAILABLE FOR RETURN. THERE WERE NO COMPLAINTS OR DELAYS IN THE PROCEDURE. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 17851534 ↗
• MalfunctionJun 12, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE INNER STERILE PACKAGE HAD A HAIR UNDER SEAL ON FOAM INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107204 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TIBIAL INSERT WAS NOT DISLOCATED. RATHER, IT HAD SPUN OUT, AS WELL AS THE TIBIAL TRAY, AND A CLOSED REDUCTION WAS PERFORMED FOR THE FIRST BEARING SPIN OUT, NO REVISION PROCEDURE.

  Patient problems: Joint Laxity

  MAUDE report 16713245 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND POOR MOTION. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16573050 ↗