ATTUNE 1506-80-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10603295492160), received between Aug 28, 2019 and Sep 21, 2026 — classified as 85 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (18 reports).

1 FDA recall record name this device's identifier.

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. Feb 22, 2021Class IITerminated

   Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

   Z-1316-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50847136 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had painful right knee.Affected Side: Right.

  Patient problems: Pain

  MAUDE report 50452948 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTHROFIBROSIS AND INSTABILITY HAD OCCURRED. THE PATELLA WAS STABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Arthrofibrosis; Joint Laxity

  MAUDE report 25395900 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNKNOWN KNEE FEMORAL, UNKNOWN KNEE TIBIAL TRAY, AND UNKNOWN KNEE TIBIAL INSERT WERE INVOLVED IN A KNEE REPLACEMENT EVENT. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS FOLLOWING BILATERAL KNEE REPLACEMENT SURGERY, INCLUDING INFECTION, WOUND DEHISCENCE, BLEEDING, ALLERGIC REACTION TO NICKEL, FOREIGN BODY REACTION, HAIR LOSS, LOSS OF RANGE OF MOTION, KNEE SWELLING, NIGHT SWEATS, SCAR TISSUE FORMATION, AND FALLS. THE PATIENT REQUIRED INTRAVENOUS ANTIBIOTICS AND UNDERWENT ALLERGY TESTING, CONFIRMING NICKEL SENSITIVITY. A REVISION PROCEDURE IS PLANNED FOR THE RIGHT KNEE, WHILE THE LEFT KNEE CONTINUES TO CAUSE SIGNIFICANT PAIN. THIS REPORT IS FOR THE LEFT KNEE.

  Patient problems: Adhesion(s); Distress; Fall; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Swelling/ Edema; Unspecified Infection

  MAUDE report 24588966 ↗
• InjuryFeb 25, 2026Loss of or Failure to Bond

  HEALTH AUTHORITY REPORT MW5181909 WAS REPORTED TO MANUFACTURER: IT WAS REPORTED THAT ATTUNE RP TIB BASE SZ 4 CEM, ATTUNE MEDIAL DOME PAT 38MM, ATTUNE PS FEM LT SZ 4 CEM, AND UNKNOWN KNEE TIBIAL INSERT WERE ASSOCIATED WITH A REPORTED EVENT. THE PATIENT EXPERIENCED INCREASED SWELLING, PAIN, DECREASED MOBILITY, AND WALKING DIFFICULTY FOLLOWING A TOTAL KNEE REPLACEMENT. IMAGING INDICATED POSSIBLE IMPLANT LOOSENING, AND A REVISION SURGERY WAS PERFORMED WITH A DIAGNOSIS OF FAILED ARTHROPLASTY AND AN OCCULT FRACTURE OF THE ANTERIOR TIBIA. THE TIBIAL INSERT WAS REVISED TO PROVIDE ACCESS TO THE SURGICAL SITE, AND IT WAS NOTED THAT THE LOOSE IMPLANTS MAY HAVE CONTRIBUTED TO THE EVENT DUE TO THEIR BONDING INTERFACE AND RESISTANCE TO LOOSENING. THE IMPLANTS WERE EXPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 24443678 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA AND INSERT REVISED DUE TO INSTABILITY AND PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23645662 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  ADDITIONAL INFORMATION WAS RECEIVED: TIBIA SUBSIDED WHICH LED TO LIGAMENTAL INSTABILITY. IT CANNOT BE DETERMINED IF MALPOSITIONING/UNDERSIZING OF EITHER COMPONENT LED TO THIS.

  Patient problems: Joint Laxity

  MAUDE report 23351137 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIBIA SUBSIDED MEDIALLY. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23088789 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION AND NEEDED IMPLANTS REMOVED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23036957 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED A TKR. REASON FOR REVISION WAS PAIN AND LOOSENING. SURGEON REMOVED FEMUR, TIBIA AND POLY INSERT IMPLANTS WHICH WERE WELL FIXED AND IN GROWN. CEMENTLESS FEMUR APPEARED TO BE IMPLANTED IN FLEXED POSITION WHICH LEFT A GAP BETWEEN THE ANTERIOR DISTAL FEMORAL BONE AND THE IMPLANT. POSTERIOR FEMUR HAD VERY GOOD BONE IN GROWTH AND WAS DIFFICULT TO REMOVE. ATTUNE REVISION IMPLANTED. PATELLA WAS LEFT IN-SITU. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 22877070 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT NEEDED TO BE REVISED DUE TO GLOBAL INSTABILITY. SURGEON FELT IT BEST TO CONVERT TO A HINGED PROSTHESIS. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22680709 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT PAIN. THE PATIENT REQUIRED TOTAL KNEE REVISION.

  Patient problems: Pain

  MAUDE report 22187077 ↗
• InjuryJun 5, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA) TO ADDRESS SIGNIFICANT ARTHRITIS INVOLVING HER LEFT KNEE. ATTUNE KNEE SIZE 4 TIBIAL BASE PLATE, A SIZE 5 POSTERIOR STABILIZED ATTUNE FEMUR, A SIZE 5 5MM THICK POLYETHYLENE ROTATING PLATFORM TIBIAL INSERT COMPONENT, AND 38MM ALL-POLY PATELLA WERE IMPLANTED. SMART SET GMV GENTAMICIN BONE CEMENT WAS UTILIZED DURING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED. LESS THAN FOUR YEARS AFTER HER INITIAL LEFT KNEE IMPLANT SURGERY, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE FEMUR AND TIBIAL TRAY COMPONENTS. THE PATIENT PRESENTED WITH FLUID ON THE KNEE, AND SYNOVITIS. OPERATIVELY, THERE WAS MINIMAL CEMENT ADHESION TO THE IMPLANTS (ONLY 20% BENEATH FEMUR, AND 40% BENEATH THE TIBIAL TRAY). THE PATELLA IMPLANT WAS RETAINED. ATTUNE REVISION KNEE COMPONENTS WERE IMPLANTED FOR FEMUR AND TIBIAL SIDE COMPONENTS.

  Patient problems: Swelling/ Edema; Synovitis

  MAUDE report 22148453 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INVESTIGATOR INITIATED STUDY (IIS) (B)(6) . PATIENT RECEIVED ATTUNE IMPLANT AS PART OF THE STUDY. EVENT: DVT CALF R LEG START DATE: (B)(6) 2024 / SURGERY DATE: (B)(6) 2024, EVENT START DATE: (B)(6) 2024. AS NOTED ON SITE FORM: EVENT DID NOT OCCUR AT THE OPERATIVE SITE / THE INVESTIGATOR OPINION WAS THE EVENT WAS UNANTICIPATED, POSSIBLY RELATED TO THE PROCEDURE AND UNRELATED TO THE STUDY DEVICE I.E. ATTUNE IMPLANT / SEVERITY WAS LISTED AS MILD AND CONSIDERED SERIOUS. US RADIOLOGY CONFIRMED DVT (B)(6) 2024, PATIENT COMMENCED ON ELIQUIS 5MG X 2 BD FOR 1-WEEK / X1 BD FOR 2-WEEKS RESOLVED REVIEW ULTRASOUND (B)(6) 2024 OUTCOME NOTED AS 'RESOLVED, NO SEQUELAE' PATIENT WAS NOT WITHDRAWN FORM THE STUDY AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22117899 ↗
• InjuryMay 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT CAME WITH A COMPLAINT OF PAIN TO THE RIGHT KNEE. PATIENT HAD A TOTAL KNEE REPLACEMENT IN (B)(6) 2024. PATIENT HAD NEVER BEEN PAIN FREE SINCE THE SURGERY. DOCTOR RULED OUT THE POSSIBILITY OF INFECTION IN THE JOINT THEN ORDERED A BONE SCAN. THE RESULTS FROM THE BONE SCAN INDICATED THAT THE MEDIAL SIDE OF THE TIBIAL COMPONENT SHOWED SIGNS OF LOOSENING. DOCTOR SCHEDULED THE PATIENT FOR REVISION SURGERY. DURING THE REVISION SURGERY IT WAS INSPECTED THAT THE FEMORAL COMPONENT FIRST AND NOTED THAT IT WAS WELL FIXED. THE POLY INSERT WAS REMOVED THEN THE TIBIAL COMPONENT WAS INSPECTED AND DETERMINED THAT IT HAD SOME MICRO MOTION ON THE MEDIAL SIDE CONSISTENT WITH THE FINDINGS OF THE BONE SCAN. DOCTOR DECIDED TO REMOVE THE TIBIAL COMPONENT AND REVISE IT TO AN ATTUNE TIBIAL TRAY WITH A SLEEVE AND STEM, AND LEAVE THE FEMORAL COMPONENT DUE TO IT BEING WELL FIXED. SO DOCTOR PLACED A SZ 4 6MM PRIMARY POLY TO MATCH THE SZ 4 FEMORAL COMPONENT AND NOTED THAT THE JOINT WAS STABLE AND HAD GREAT RANGE OF MOTION. IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS DEPUY SYNTHES. CEMENT WAS MIXED FOR ONE MINUTE

  Patient problems: Pain

  MAUDE report 22099902 ↗
• MalfunctionMay 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? PATIENT OUTCOME WAS NOT AFFECTED AS THE DOCTOR NOTICED THE ISSUE AND REQUESTED A NEW BATCH OF CEMENT AND A NEW TIBIA BASEPLATE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009906 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED OF ATTUNE KNEE DUE TO INSTABILITY. SURGEON EXPLANTED COMPONENTS REVISING WITH ATTUNE CRS. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21945658 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S MEDIAL TIBIAL BONE WAS COLLAPSING SO THE EXISTING TIBIAL BASE AND POLY WERE REMOVED AND THEN REVISED PATIENT WITH NEW IMPLANTS. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED ORE SUCCESSFULLY COMPLETED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21776110 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ATTUNE RIGHT IMPLANTED ON (B)(6) 2024 IS HAVING INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 21448168 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. IMPLANTS WERE REMOVED AND REPLACED WITH IMPLANT SPACER. DOI: (B)(6), 2024 DOR: (B)(6), 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21199766 ↗
• InjuryJan 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 DUE TO STIFFNESS. FEMUR TRAY AND POLY WERE ALL REVISED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 21180845 ↗
• InjuryDec 30, 2024Loss 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 Q4 OF 2024. 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 TIBIAL LOOSENING (UNKNOWN INTERFACE) AND PAIN.

  Patient problems: Pain

  MAUDE report 21035014 ↗
• InjuryDec 27, 2024Adverse 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 Q4 OF 2024. (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 INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21028562 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20883900 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN ATTUNE PS RP CONSTRUCT IMPLANTED (B)(6) 2024 WAS REVISED ON (B)(6) 2024 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. THE AREA WAS THOROUGHLY CLEANED AND DEBRIDED. ATTUNE REVISION WAS THEN IMPLANTED. PATIENT RIGHT SIDE WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 20495428 ↗