ATTUNE 1504-10-224Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295041832), received between Jul 5, 2017 and Sep 21, 2026 — classified as 44 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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 46 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Unspecified Infection

  MAUDE report 50847350 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN DURING A POST-OPERATIVE FOLLOW-UP, AND IMAGING REVEALED A FRACTURE OF THE LATERAL FEMORAL CONDYLE. THE PATIENT REPORTED A FALL DOWNSTAIRS, AND BOTH IMPLANT COMPONENTS WERE SUBSEQUENTLY REMOVED FROM THE RIGHT KNEE. DOI-(B)(6) 2026, DOR-(B)(6) 2026, AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Fall; Limb Fracture; Pain

  MAUDE report 24731975 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY CAUSED BY MEDIAL TIBIAL TRAY SUBSIDENCE. DR. REMOVED THE PATIENT'S ATTUNE PRIMARY INSERT, FEMUR, AND TIBIAL TRAY. DR. REPLACEMENT THEM WITH ATTUNE REVISION IMPLANTS, TO INCLUDE A MEDIAL TIBIAL AUGMENT AND PRESS-FIT STEMS. DOI: (B)(6) 2019, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24520936 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING KNEE PAIN AND INSTABILITY. DOI: (B)(6) 2018, DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22676767 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR INSTABILITY. IMPLANTS WERE REMOVED AND AN ATTUNE REVISION WAS PLACED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22010470 ↗
• 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 21945674 ↗
• 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 20883579 ↗
• InjuryMar 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION FOR DESCHELLEMENT PTG KNEE RIGHT DUE TO LOOSENING OF FEMUR-TIBIA. THERE WAS NO DELAY.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 18940297 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF IMPLANTS (TIBIAL INSERT) AT UNKNOWN INTERFACE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 18757421 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE FIRST DAY AFTER SURGERY, A FOLLOW-UP ULTRASOUND WAS PERFORMED ON THE RIGHT LOWER LIMB BLOOD VESSELS, AND THE RESULTS SHOWED PARTIAL INTRAMUSCULAR VEIN THROMBOSIS AND POSTERIOR TIBIAL VEIN THROMBOSIS IN THE RIGHT LOWER LIMB.

  Patient problems: Loss of Range of Motion; Thrombosis/Thrombus

  MAUDE report 18314822 ↗
• InjuryOct 16, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AND TIBIA OF THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS REVISED TO A CRS RP CONSTRUCT. DOI: (B)(6) 2018 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17944841 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED BECAUSE OF CONSTANT KNEE PAIN. THERE WAS NO EVIDENCE OF LOOSENING OR INSTABILITY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17731480 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. IMPLANTS WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16494761 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIBIAL SUBSIDENCE AND POOR BONE QUALITY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15503323 ↗
• MalfunctionSep 24, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THE IMPLANT WAS DIFFICULT TO REMOVE FROM PACKAGING AFTER UNSTERILE PACKING WAS OPEN. BOTH THE NURSE AND SURGEON ATTEMPTED TO REMOVE THE IMPLANT AND COULD NOT REMOVE IT. THE ITEM WAS DISCARDED AND ANOTHER IMPLANT WAS OPEN TO AVOID SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT. MINOR SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481483 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14167296 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNEE BEING UNSTABLE IN EXTENSION. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 14039887 ↗
• MalfunctionJan 7, 2022Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS CONFIRMED THAT THERE WERE TRACES OF DIRT AND PROTECTIVE COVERS ON THE SURFACE OF THE TRAY. IT WAS ALSO CONFIRMED THAT THE BLISTER PACK HAD BEEN SLIPPED OUT OF PLACE. THE TRAY WAS USED AS IT WAS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE ADVERSE EVENT TO THE PATIENT IS NOT REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13191817 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, STIFFNESS, FLEXION CONTRACTURE, EXTENSIVE SCAR TISSUE AND LOOSENING. UPON ENTERING THE JOINT, THE TIBIAL COMPONENT WAS IDENTIFIED AT LOOSE AT THE CEMENT TO IMPLANT INTERFACE. ALL IMPLANTS WITH THE EXCEPTION OF THE PATELLA WERE REVISED. NO INDICATION OF PRODUCT DEFICIENCY RELATED TO THE FEMORAL, INSERT OR PATELLA COMPONENTS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Contracture; Muscular Rigidity; Pain

  MAUDE report 11995091 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TKA TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 1 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN AND CONTRACTURE WITH SUSPECTED LOOSENING. UPON ENTERING THE JOINT, SYNOVITIS WAS DEBRIDED, AND EXCESSIVE EFFUSION WAS EVACUATED. THE FEMORAL COMPONENT HAD BONE EROSION ON THE CONDYLES AND REVISED. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH A DEPUY REVISION CONSTRUCT UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2019, RIGHT KNEE.

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

  MAUDE report 11657748 ↗
• InjuryApr 5, 2021Loss of or Failure to Bond; Use of Device Problem; Loss of or Failure to Bond; Use of Device Problem

  ON (B)(6) 2015 THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS OF THE RIGHT KNEE. DUE TO PATIENT¿S POOR BONE STOCK, PINS IN THE DISTAL FEMUR AND IN PROXIMAL TIBIA WERE NOT SATISFACTORY SO THE PLANS FOR COMPUTER ASSISTED SURGERY WERE ABANDONED. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X1 WERE IMPLANTED DURING THIS PROCEDURE. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED. (STICKER PAGE 7 OF 12). ON (B)(6) 2018, THE PATIENT HAD A REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS FAILED TOTAL RIGHT KNEE. DURING THE PROCEDURE THE SURGEON OBSERVED HYPERTROPHIC SYNOVIAL TISSUE, GROSS LOOSENING OF THE TIBIAL COMPONENT ALONG WITH SUBSIDENCE. THE LOOSENING OF THE TIBIAL TRAY WAS AT THE IMPLANT/CEMENT INTERFACE. THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE (NO INTERFACE), VARUS MALALIGNMENT AND OSTEOLYTIC AREA OF BONE. THE PATELLA WAS NOT REVISED. DEPUY COMPONENTS, INCLUDING DEPUY CEMENT X2 WERE IMPLANTED DURING THIS PROCEDURE. (PART/LOT PAGE 12 OF 12). DOI: (B)(6) 2015 DOR: (B)(6) 2018 (RIGHT KNEE).

  Patient problems: Local Reaction; Pain

  MAUDE report 11614753 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE RENAL FAILURE, HYPOTENSION, ALTERED MENTAL. STATUS, DEAFNESS, AND INCIDENTAL STROKE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2013, DATE OF EVENT (ONSET): (B)(6) 2013, (RIGHT KNEE). TREATMENT: MEDICAL INTERVENTION/ MODIFICATION; DIAGNOSTIC INTERVENTION; OBSERVATION.

  Patient problems: Hearing Impairment; Low Blood Pressure/ Hypotension; Renal Impairment; Stroke/CVA; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 11350919 ↗
• InjuryNov 25, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2014: PATIENT UNDERWENT A RIGHT KNEE ATTUNE ARTHROPLASTY. THE PATELLA WAS RESURFACED, AND CEMENT MANUFACTURER WAS COMPETITOR. THERE WERE NO COMPLICATIONS NOTED. MEDICAL RECORDS INDICATE THE PATIENT UNDERWENT AN INJECTION OR NERVE STIMULATOR DURING HER ADMISSION OF HER RIGHT KNEE ARTHROPLASTY ON (B)(6) 2014. THE PROCEDURE NOTES AREN¿T COMPLETE SO AS THIS TIME IT¿S UNKNOWN WHY THE PATIENT UNDERWENT THE PROCEDURE. ON (B)(6) 2020: PATIENT UNDERWENT A RIGHT KNEE REVISION AND THE TIBIAL AND FEMORAL COMPONENTS WERE BOTH NOTED TO BE LOOSE. LOOSENING INTERFACE WASN¿T NOTED. INFECTION WAS RULED OUT. ATTUNE REVISION TIBIAL IMPLANTS WERE PLACED WITH COMPETITOR CEMENT. DOI: (B)(6) 2014. DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 10906184 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC EFFUSION, REDUCED RANGE OF MOTION (+15 TO +80 DEGREES), PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. SHE HAD A PREVIOUS POLY REVISION BY THE SURGEON ON (B)(6) 2016. SHE HAD A FLEXION-EXTENSION GAP MISMATCH OF 4MM. THE ATTUNE TIBIAL TRAY CAME OUT WITH RELATIVE EASE ALTHOUGH SALES REP WAS SURE THAT THE SURGEON ALSO CHECKED THE FIXATION OF THE TIBIAL TRAY WHEN HE DID THE FIRST REVISION WITH POLY EXCHANGE BACK IN 2016. THE TRAY CAME OUT WITH EASE AND NO CEMENT ON THE BACK OF THE TRAY. DOI: (B)(6) 2015; (B)(6) 2016 ( TIBIAL INSERT ), DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10621429 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE REVIEWED: ON (B)(6) 2019, THE PATIENT UNDERWENT A PRIMARY RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. MULTIPLE POST-OPERATIVE EVALUATIONS BETWEEN THE DATES OF (B)(6) 2019 TO (B)(6) 2020 INDICATED THE PATIENT WAS EXPERIENCING THE FOLLOWING ISSUES: PAIN, DISCOMFORT, DECREASED RANGE OF MOTION, SWELLING, STIFFNESS, EFFUSION, INFLAMMATION, AND WALKING DIFFICULTY. EVENTUALLY LEADING TO THE REVISION OPERATION ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS THE AFOREMENTIONED SYMPTOMS INDICATED ABOVE BETWEEN THE DATES OF (B)(6) 2019 TO (B)(6) 2020. THE SURGEON INDICATED POSSIBLE TIBIAL TRAY LOOSENING; HOWEVER, THIS WAS NOT CONFIRMED WITHIN THE OPERATIVE NOTE. THERE WAS 1 MM TO 2 MM OF FIBROUS TISSUE INTER-POSITIONED BETWEEN THE CEMENT AND BONE AT THE PROXIMAL TIBIA. THERE WAS ALSO NOTED PARAPATELLAR FIBROSIS REMOVED. THE PATELLAR COMPONENT WAS WELL-FIXED AND RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Discomfort; Edema; Inflammation; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10574094 ↗