ATTUNE 1504-00-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295041054), received between Sep 22, 2017 and Jul 10, 2026 — classified as 33 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNSTABLE PRIMARY. IT WAS STATED THAT TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25780385 ↗
• MalfunctionJun 19, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE IMPLANT WAS OPEN AND A PIECE OF PLASTIC WAS SITTING ON THE IMPLANT. DOE: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25567800 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE PAIN OF LEFT KNEE - PRIMARY CHRONIC PAIN OF RIGHT KNEE, OSTEOARTHRITIS OF RIGHT KNEE, ACUTE PAIN OF LEFT KNEE. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2022. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: INJECTED MEDICATION: YES.

  Patient problems: Pain

  MAUDE report 24459477 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22375952 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN / INSTABILITY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22020602 ↗
• InjuryJun 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED, ASEPTIC LOOSENING OF THE ATTUNE FEMORAL COMPONENT. DOI: (B)(6) 2021. DOE: (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19616368 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED): CATALOG ID: 150400104. LOT ID: D23071618 COMPONENT TYPE: FEMORAL DESCRIPTION: ATTUNE C/RET FEM LT SZ 4 CEMENTED. CATALOG ID: 150670004 LOT ID: D23063313 COMPONENT TYPE: TIBIAL DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 4. CATALOG ID: 151820406 LOT ID: M2369W COMPONENT TYPE: INSERT DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 4 6MM. CATALOG ID: 151820035 LOT ID: 4267414 COMPONENT TYPE: PATELLAR. DESCRIPTION: ATTUNE MEDIAL DOME PAT 35MM CATALOG ID: 3312040 LOT ID: 4071983 COMPONENT TYPE: CEMENT DESCRIPTION: SMART SET CMW 1 40G CATALOG ID: 3312040 LOT ID: 4023922 COMPONENT TYPE: CEMENT DESCRIPTION: SMART SET CMW 1 40G.

  Patient problems: Muscular Rigidity

  MAUDE report 18729751 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: 21 NOV 2023. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 18273913 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PRIMARY SURGERY WAS PERFORMED VIA TKA FOR THE LEFT OA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023, TO REMOVE THE IMPLANTS, TO CLEAN THE AFFECTED AREA AND TO INSERT CEMENT MOLD, DUE TO THE DELAYED ONSET INFECTION. THE RE-REVISION SURGERY IS SCHEDULED ON AN UNKNOWN DATE WHEN THE INFECTION IS CURED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16843324 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE BLOOD LOSS ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2018. (LEFT KNEE). TREATMENT: INJECTED MEDICATION.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16609054 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE REPLACEMENT. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16146634 ↗
• InjuryNov 4, 2022Use of Device Problem; Use of Device Problem

  REVISION OF TKR FOR BEARING SPIN OUT + FEMORAL ROTATION FROM ORIGINAL PRIMARY . PATIENT'S ORIGINAL PRIMARY SURGERY WAS DONE ON (B)(6) 2022 AND SHE HAD A POLY EXCHANGE ON (B)(6) 2022 AND THEN HAD ANOTHER REVISION FOR BEARING SPIN OUT AND THE POLY AND THE FEMUR WERE CHANGED. ALL PROCEDURES DONE AT CALVARY ADELAIDE BY PROF FOR LEFT KNEE. DOI: ON (B)(6) 2022. DOR: ON (B)(6) 2022. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15728228 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF INFECTED ATTUNE TKR AND DISTAL PERIPROSTHETIC PLATES AND SCREWS LEFT FEMUR. SEE (B)(4) FOR DETAILS OF FIRST REVISION. PATIENT HAS SINCE HAD CONFIRMED INFECTION IN LEFT KNEE. THIS PROCEDURE WAS TO REMOVE ALL COMPONENTS INCLUDING THE DISTAL PLATES AND SCREWS AND DEBRIDE, WASHOUT AND INSERT SPACER. CONFIRMED ON REMOVAL THAT THE DISTAL LATERAL PLATE AND SCREW WERE DEPUY SYNTHES PRODUCT. DOI: (B)(6) 2021; DOR: (B)(6) 2022; UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13619596 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LEFT ATTUNE TKR ON 14/05/18. PATIENT SUBSEQUENTLY FELL ON (B)(4). 2018 AND SUFFERED A LEFT DISTAL FEMORAL PERIPROSTHETIC FRACTURE. THIS WAS TREATED WITH DISTAL FEMORAL PLATING. DOI: (B)(6) 2018; DOE: (B)(6) 2018; AFFECTED SIDE: LEFT KNEE. THIS PC WAS LINKED TO (B)(4) AS MOTHER PC AND (B)(4).

  Patient problems: Fall; Limb Fracture

  MAUDE report 12959917 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2016 WHERE AN ATTUNE CR FIXED BEARING WAS UTILIZED. PATIENT WAS PRESENTED TO SURGEON FOLLOWING A FALL IN THE SHOWER. X RAYS SHOW A PERIPROSTHETIC DISTAL FEMORAL FRACTURE AROUND THE DISTAL CONDYLES AND JUST PROXIMAL TO THE FEMORAL COMPONENT. A DECISION WAS MADE TO OPEN THE KNEE, REMOVE THE EXISTING FEMORAL AND TIBIA COMPONENTS AND IMPLANT AN ATTUNE REVISION TIBIAL COMPONENT WITH SLEEVE AND STEM, AND REPLACE THE FEMORAL COMPONENT WITH A DISTAL FEMORAL REPLACEMENT. AS THIS PATIENT HAS HAD A PREVIOUS PATELLECTOMY, THE PATELLA WAS NOT TOUCHED.

  Patient problems: Fall; Limb Fracture

  MAUDE report 12823464 ↗
• InjurySep 27, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY. AFTER THE SURGERY, BECAUSE THE PATIENT¿S KNEE BALANCE WAS POOR, THE PATIENT USED AN ORTHOSIS AND WATCHED HOW IT WENT, BUT ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY FOR HIS/HER LEFT KNEE DUE TO LOOSENING OF THE IMPLANTS. THERE WAS NO PROBLEM ON THE TIBIAL SIDE, AND THE IMPLANT ON THE TIBIAL SIDE WAS LEFT IN PLACE. FEMORAL SIDE WAS TREATED USING AN EXTENDED STEM AND AN INSERT IN THE REVISION SURGERY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12532208 ↗
• InjuryJun 3, 2021Use of Device Problem; Use of Device Problem

  PATIENT RECEIVED BILATERAL ATTUNE TOTAL KNEES TO TREAT OSTEOARTHRITIS. THE LEFT PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, MISPOSITIONED FEMORAL COMPONENT, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. PRE-OPERATIVE X-RAYS DEMONSTRATED SUBLUXATION OF THE PATELLA. ALL COMPONENTS WERE REVISED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11929634 ↗
• MalfunctionMay 18, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  KNEE SURGERY/KTEP: PREPARATION WAS FINISHED, IMPLANTS TAKEN OUT OF BOXES. ON FEMUR-COMPONENT TRACES OF ADHESIVE WERE FOUND. THIS IMPLANT WAS REJECTED. ANOTHER ONE WAS IMPLANTED. NO SURGERY DELAY. PROCEDURE SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841643 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, DECREASED RANGE OF MOTION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED EXCISION OF DENSE SCAR TISSUE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2018, DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11603342 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME HEALTH ISSUES AND STARTED TO COMPLAIN OF SOME KNEE PAIN. HE SAID THAT HE DID A WORKUP AND FOUND OUT THAT HE HAD A KNEE INFECTION. THE SURGEON REMOVED ALL THE COMPONENTS AND USE SIGMA RP IMPLANTS AS A SPACER UNTIL THE INFECTION HEALED. THE IMPLANTS ARE WELL FIXED. THE SURGEON REMOVED ALL IMPLANTS EXCEPT FOR THE PATELLA BECAUSE HE WAS CONCERNED WITH THE AMOUNT OF BONE LOSS AND WHAT BONE WOULD BE LEFT TO WORK WITH. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11517616 ↗
• InjuryMar 4, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS AD (B)(6) 2021 WERE REVIEWED. ON (B)(6) 2015, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT TRICOMPARTMENTAL KNEE OSTEOARTHRITIS. NO COMPLICATIONS WERE NOTED DURING THIS PROCEDURE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED. ON (B)(6) 2018, THE PATIENT HAD A REVISION TO ADDRESS ASEPTIC LOOSENING. THE INDICATIONS FOR SURGERY INCLUDED WORSENING PAIN, INSTABILITY AND PREOPERATIVE RADIOGRAPHS WERE REPORTED TO SHOW DISPLACEMENT OF THE TIBIAL COMPONENT WITH EVIDENCE OF LOOSENING OF THE FEMORAL COMPONENT. DURING THE PROCEDURE, THE SURGEON OBSERVED, ABUNDANT SYNOVITIS, EXTENSIVE EROSIONS AROUND THE JOINT IMPLANTS, THE FEMORAL COMPONENT WAS LOOSE AT THE COMPONENT/CEMENT INTERFACE. THE TIBIAL TRAY WAS LOOSE AT THE COMPONENT/CEMENT INTERFACE. THERE WAS LARGE EROSIONS/BONE LOSS. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. THERE WAS NO ALLEGATION OF DEFICIENCY FOR THE PATELLA, AND NO MENTION OF REVISING IT. DOI: (B)(6) 2015 DOR: (B)(6) 2018, (LEFT KNEE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain; Synovitis

  MAUDE report 11414927 ↗
• InjuryJun 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT RECEIVED LEFT PRIMARY ATTUNE TKA TO TREAT KNEE PAIN SECONDARY TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVE A LEFT KNEE REVISION DUE INSTABILITY SECONDARY TO LOOSENING OF THE TIBIAL INSERT. UPON ENTERING THE JOINT, THE INSERT WAS NOTED TO BE DISLOCATED AND EXTERNALLY ROTATED ON THE MEDIAL SIDE AND NO LONGER UNDER THE FEMORAL COMPONENT CAUSING A LARGE LAXITY ON THE FEMORAL SIDE. THE FEMORAL COMPONENT, TIBIAL TRAY, AND PATELLA WERE WELL-FIXED AND RETAINED. THE MANUFACTURER OF THE REVISED TIBIAL INSERT WAS NOT PROVIDED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10134279 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE REPLACEMENT TO ADDRESS CHRONIC PAIN AND OSTEOARTHRITIS. PATELLA WAS RESURFACED. AND DEPUY BONE CEMENT WAS UTILIZED. NO COMPLICATIONS WERE REPORTED. COMORBIDITY IDENTIFIED BMI: 29.98. ON (B)(6) 2020, LEFT KNEE WAS REVISED TO ADDRESS PAIN, TIBIAL BASEPLATE ASEPTIC LOOSENING (AT CEMENT IMPLANT INTERFACE), AND KNEE ARTHROFIBROSIS. THE FEMUR WAS NOT GROSSLY LOOSE AND WAS REMOVED WITH INSTRUMENTS. THE TIBIAL BASE PLATE WAS GROSSLY LOOSE, HAVING COMPLETELY DEBONDED FROM THE CEMENT MANTLE. THE TIBIAL BASE PLATE REPORTEDLY SUBSIDED 5 TO 8MM. THE PATELLA WAS RETAINED. SYNOVECTOMY PERFORMED. COMPETITOR KNEE REVISION SYSTEM WITH COMPETITOR CEMENT UTILIZED FOR TREATMENT. DOI: (B)(6) 2017. DOR: (B)(6) 2020; (LEFT KNEE).

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9986695 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR LEFT TOTAL KNEE REVISION TO ADDRESS INSTABILITY DATE OF IMPLANTATION: UNKNOWN. DATE OF REVISION: (B)(6) 2019, (LEFT KNEE). WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: No Code Available

  MAUDE report 9592650 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017: THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. ATTUNE IMPLANTS WERE UTILIZED WITH DEPUY CEMENT X1. PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2019: THE PATIENT UNDERWENT LEFT KNEE REVISION DUE TO PERSISTENT PAIN, SWELLING, INSTABILITY AND SUSPECTED LOOSENING. SURGEON INDICATES THE CASE COMPLEXITY IS HIGH DUE TO ¿SEVERE LIGAMENTOUS LAXITY FROM THE FAILED KNEE ARTHROPLASTY.¿ THE INTRAOPERATIVE NOTES DO NOT CLEARLY CONFIRM LOOSENING BUT NOTES THE COMPONENTS WERE REMOVED WITHOUT COMPLICATIONS OR BONE DAMAGE. INTRAOPERATIVELY, SURGEON REVISES ALL COMPONENTS (PATELLA, FEMORAL, INSERT AND TIBIAL) AND REPLACED WITH NON-DEPUY REVISION KNEE SYSTEM AND WITH NON-DEPUY CEMENT. DOI: (B)(6) 2017. DOR: (B)(6) 2019, (PATELLA, FEMORAL, TIBIAL AND INSERT).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9554698 ↗