ATTUNE 1506-60-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10603295042884), received between Sep 10, 2018 and Sep 25, 2026 — classified as 85 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (15 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 90 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50904678 ↗
• InjuryJun 15, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY, SLEEVE, AND STEM AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION POST REVISION TKA. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTICS AND RESORBABLE ANTIBIOTIC BEADS. SIGNIFICANT BONE LOSS WAS NOTED ON THE TIBIA AS THE INFECTION APPEARED TO HAVE BEEN PRESENT FOR SOME TIME BUT WAS UNTREATED UNTIL PATIENT SHOWED UP IN THE ER. NO DELAY OR PATIENT HARM WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: AUGUST 10, 2023. DOR: MAY 20, 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Notching; Unspecified Infection

  MAUDE report 25503644 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATUNE PRESSFIT STR STEM14X60MM, ATUN TIB SLV M/L 45MM FULL POR, ATUNE REV RP TIB BASE SZ 4 CEM, ATTUNE REV LPS INSRT XXSM 12MM, LPS DISTAL FEM COMP XXSM RT, ATT REV SLV LPS FEM ADP +5, ATUN FEM SLV M/L 45MM FULL POR, AND ATUN PRESSFIT STR STEM12X110MM WERE INVOLVED IN A REPORTED EVENT. THE PATIENT, WHO HAD PREVIOUSLY RECEIVED A REVISION KNEE POST SPACER FOR INFECTION, PRESENTED WITH WOUND DRAINAGE. ALL IMPLANTED COMPONENTS WERE REMOVED, AND THOROUGH DEBRIDEMENT AND IRRIGATION WERE PERFORMED. A NEW SPACER WAS FASHIONED USING LPS COMPONENTS, RESORBABLE ANTIBIOTIC BEADS, AND HIGH-DOSE ANTIBIOTIC CEMENT. NO DEVICE MALFUNCTION WAS ALLEGED, AND ALL COMPONENTS WERE REPORTED TO BE FUNCTIONING AS EXPECTED. THE TIBIAL COMPONENT WAS WELL FIXED, AND THE EVENT WAS ATTRIBUTED TO INFECTION RATHER THAN DEVICE FAILURE. ALL LISTED PRODUCTS WERE EXPLANTED DURING THE PROCEDURE AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24258275 ↗
• InjuryJan 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF AN ATTUNE DUE TO LOOSE FEMORAL AND TIBIAL COMPONENTS. THE SURGEON NOTED FIBROUS TISSUE UP THE FEMORAL CANAL AROUND THE FEMORAL STEM CAUSING LOOSENING. THE TIBIAL COMPONENT WAS LOOSE AS IT APPEARED THAT THE SURGEON HAD CEMENTED IN THE CEMENTLESS TIBIAL SLEEVE. RESULTING IN NO BONE INGROWTH. THE PATELLA COMPONENT WAS RETAINED FROM PREVIOUS PRIMARY TKR. THE LOOSENING WAS BETWEEN THE IMPLANT AND BONE INTERFACES. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958200 ↗
• InjuryDec 23, 2025Loss of or Failure to Bond; No Apparent Adverse Event; Loss of or Failure to Bond; No Apparent Adverse Event

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL AND FEMORAL COMPONENT LOOSENING ON INDEX KNEE, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: DEFINITELY, DATE OF EVENT: UN JAN 2025, DATE OF IMPLANT: ON (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT, TREATMENT/IMPACT: OTHER: TRUE, IF OTHER ¿ SPECIFY: PLANNED TO HAVE REVISION SURGERY ON (B)(6) 2026.

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

  MAUDE report 23880539 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CRS FEMORAL RT SZ 5 CEM, ATUNE PRESSFIT STR STEM12X60MM, ATTUNE CEMENTED STEM 14X50MM, ATTUNE CRS RP INSRT SZ 5 6MM, ATUNE REV RP TIB BASE SZ 4 CEM, ATUN TIB SLV M/L 29MM HALF POR, AND ATTUNE MEDIAL ANAT PAT 32MM WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A REVISION OF A PREVIOUS ATTUNE REVISION PROCEDURE, WITH THE REASON FOR REVISION BEING INFECTION. THE SURGEON SUSPECTED INFECTION AT THE TIME OF IMPLANTATION DUE TO POOR INGROWTH IN THE TIBIAL SLEEVE AND NOTED THAT THE CEMENTED FEMORAL STEM WAS EASILY REMOVED. THE EVENT WAS ASSOCIATED WITH THE RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23862878 ↗
• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL EVENT INFORMATION REVIEWED AND RECEIVED ON 04-NOV-2025 AND 03-NOV-2025: UPDATES RECEIVED: DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: DEFINITELY. CLINICAL UPDATE RECEIVED ON 26 NOV 2025: UPDATES RECEIVED: DIAGNOSIS: LATERAL KNEE PAIN ON LEFT KNEE FOUND TO HAVE TIBIAL AND FEMORAL COMPONENT LOOSENING; LATERAL KNEE PAIN. ADDITIONAL EVENT INFORMATION REVIEWED AND RECEIVED: CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL AND FEMORAL COMPONENT LOOSENING ON INDEX KNEE TREATMENT/IMPACT: OTHER (PLANNED TO HAVE REVISION SURGERY IN (B)(6) 2026).

  Patient problems: Pain

  MAUDE report 23554347 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A 5X6 CRS INSERT WAS PUT IN, ON (B)(6) 2022 A 5X5PSRP INSERT WAS PUT IN. PATIENT IS VERY STIFF. PATIENT HAS REQUESTED THE DOCTOR TO TRY ANYTHING TO MAKE KNEE MOVE. DR BELIEVES THE ONLY THING CAN OFFER IS TO CONVERT THIS REV KNEE TO A HINGE. DR. HAS REQUESTED TO HAVE THE ATTUNE REV HINGE SYSTEM SO DR. DOES NOT HAVE TO REMOVE THE WELL FIXED SLEEVE IN THE FEMUR. ACTIVITY LEVEL - YES. DOI: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE. THIS REPORT CAPTURES THE PATIENT STIFFNESS WHICH WAS OCCURRED AFTER THE 1ST REVISION SURGERY WHILE RELATED COMPLAINT (B)(4) REPORTS THE 1ST REVISION SURGERY WHICH OCCURRED IN (B)(6) 2022.

  Patient problems: Muscular Rigidity

  MAUDE report 23011426 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A COMPLEX PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2025 USING A PRIMARY ATTUNE PS FEMUR, ATTUNE PS ROTATING PLATFORM INSERT, ATTUNE REVISION ROTATING PLATFORM TIBIAL TRAY WITH ATTUNE REVISION TIBIAL SLEEVE AND ATTUNE REVISION PRESSFIT STEM. THE PATIENT HAD A PREVIOUS TIBIAL PLATEAU FRACTURE THAT HAD BEEN REPAIRED USING PLATES AND SCREWS, WHICH HAD SUBSEQUENTLY BEEN REMOVED PRIOR TO THE TOTAL KNEE REPLACEMENT SURGERY. AT THE TIME OF THE TKR SURGERY, NO CONCERNS WERE NOTED. POST-SURGERY, THE PATIENT¿S MEDIAL COLLATERAL LIGAMENT APPEARS TO HAVE FAILED (THIS OCCURRED 2 DAYS POST-OP ON (B)(6) 2025), RESULTING IN THE KNEE BEING IN SEVERE VALGUS AND X-RAY INDICATING THAT THE POLY INSERT WAS NOW ROTATED OUT OF ITS INITIAL POSITION. THE KNEE WAS SUBSEQUENTLY PLACED IN A RANGE OF MOTION BRACE AND FOLLOW-UP X-RAYS SHOWED THE KNEE TO BE IN GOOD ALIGNMENT IN BOTH THE AP AND LATERAL VIEWS. AT THIS STAGE, NO FURTHER ACTION IS PLANNED BUT THE PATIENT WILL BE REVIEWED IN A COUPLE OF WEEKS.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 22895338 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22852930 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION - ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828044 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S PRIMARY KNEE WAS DONE. THE PATIENT BEGAN TO HAVE PAIN IN TIBIA. UPON LOOKING AT XRAYS, THE SURGEON DETERMINED THE TIBIAL STEM WAS THROUGH THE LATERAL CORTEX. THE PATIENT UNDERWENT REVISION SURGERY. THE ENTIRE TIBIAL COMPONENT AND POLY WAS REMOVED, A TOTAL OF FIVE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 22784382 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO AN ARTICULATING ANTIBIOTIC SPACER DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22642021 ↗
• InjuryJul 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED AN ATTUNE + ATTUNE TIBIA REVISION OCCURRED DUE TO TIBIA LOOSENING AND INFECTION SUSPICION.

  Patient problems: Unspecified Infection

  MAUDE report 22568658 ↗
• InjuryJul 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASEPTIC MOBILIZATION POST-IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 22461127 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN NOT RESOLVING AS EXPECTED IN REVISION KNEE/PLAN TO PERFORM REVISION. DEVICE (RELATEDNESS): DEFINITELY NOT. PROCEDURE (RELATEDNESS): PROBABLY. DATE OF EVENT: 03 JUL 2020. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2022. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION OF THE STUDY KNEE TIBIAL TRAY, TIBIAL STEM, AND TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 21983973 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POST OPERATIVE HEMATOMA AFTER A COMPLEX PRIMARY KNEE REPLACEMENT UTILIZING REVISION COMPONENTS. ALL COMPONENTS WERE REMOVED AND EXCHANGED UNEVENTFULLY WITH NO PATIENT HARM NOR DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 21944672 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF COMPONENTS OF LEFT KNEE DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29-JAN-2025, DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440104, LOT NUMBER ID: J3198U, COMPONENT TYPE: FEMORAL COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151316110, LOT NUMBER ID: J2332W, COMPONENT TYPE: FEMORAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904001, LOT NUMBER ID: J32A89, COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904002, LOT NUMBER ID: J4629Y, COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 150660004, LOT NUMBER ID: 9113354, COMPONENT TYPE: TIBIAL BASE COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151214030, LOT NUMBER ID: J5202D, COMPONENT TYPE: TIBIAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151302000, LOT NUMBER ID: 8596354, COMPONENT TYPE: FEMORAL STEM OFFSET ADA

  Patient problems: Insufficient Information

  MAUDE report 21882087 ↗
• InjuryMar 5, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. THE TIBIAL COMPONENTS WERE LOOSE AND THE INTERFACE WAS NON CEMENTED. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21530159 ↗
• InjuryFeb 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A RIGHT KNEE COMPLETE SECOND REVISION WAS PERFORMED DUE TO FEMORAL AND TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. PATIENT EXPERIENCED PAIN AND REQUIRED HARDWARE REMOVAL DUE TO LOOSENING. CEMENT NOT FROM DEPUY.

  Patient problems: Pain

  MAUDE report 21409617 ↗
• InjuryJan 22, 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 PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21208905 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAINFUL (TKA) TOTAL KNEE ARTHROPLASTY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED DOI- UNKNOWN, DOR- (B)(6) 2024, AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 21154182 ↗
• InjuryDec 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  (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 TIBIAL LOOSENING (UNKNOWN INTERFACE) AND PAIN.

  Patient problems: Pain

  MAUDE report 21027734 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20589018 ↗
• InjuryOct 24, 2024Adverse 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) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20522098 ↗