ATTUNE 1516-50-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10603295052289), received between Aug 25, 2017 and Jan 30, 2026 — classified as 76 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 78 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN IN KNEE. BONE SCAN INDICATED FEMORAL MAY BE LOSE. RIGHT FEM REVISION. FEM TOOK SAWS, AND POSTERING IN ORDER TO REMOVE. REVISION FEM WAS CEMENTED IN. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24225503 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME TIGHTNESS IN THEIR KNEE, SO THE SURGEON REMOVED THE POLYETHYLENE AND DID A WASHOUT AND REPLACED WITH NEW POLY. THE SYSTEM DOES NOT GO BACK THAT FAR. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 23555212 ↗
• 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 22676773 ↗
• 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 22642034 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO MILD INSTABILITY, UNSPECIFIED PAIN AND LOOSENING OF THE PATELLA AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DURING THE SURGERY, IT WAS DISCOVERED THAT THE COMPONENT WAS LOOSE. IT WAS REPLACED WITH A 32 MM DOME PATELLA. DR. ALSO INCREASED THE THICKNESS OF THE POLY TO IMPROVE STABILITY. A SIZE 4 5 MM POLY WAS REMOVED AND A SIZE 48 MM POLY WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21954652 ↗
• 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 21945662 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-IMPLANT, THE PATIENT EXPERIENCED QUADRICEPS TEARING, AND THE SURGEON CHANGED THE INSERT TO BE SAFE. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21933520 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A PRIMARY SURGERY WITH THE INSERT IN QUESTION FOR KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2025, A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. CLEANSING WAS PERFORMED. SUBSEQUENTLY, THE INSERT IN QUESTION WAS REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 21158878 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT PATIENT WAS REVISED, DUE TO RIGHT KNEE PAIN. PATIENT HAS HAD A TOTAL KNEE ARTHROPLASTY WITH ATTUNE KNEE IMPLANTS. THE SURGEON AND ORIGINAL IMPLANT DATE AND HOSPITAL ARE UNKNOWN. PT X-RAYS, SHOWS A SLIGHT COLLAPSE OF THE MEDIAL TIBIA. A BONE SCAN WAS DONE. AND IT SHOWED, LOOSENING OF THE TIBIAL COMPONENT. REVISION SURGERY WAS SCHEDULED. DURING SURGERY THE POLY INSERT WAS REMOVED AND THE TIBIA TRAY WAS NOTED, TO BE LOOSE. THE TIBIAL TRAY WAS REMOVED. IT WAS NOTED, THAT THE FEMORAL COMPONENT AND PATELLA ARE WELL FIXED. THE TIBIA WAS THEN PREPPED FOR AN ATTUNE REVISION STEM, SLEEVE AND TIBIAL TRAY. WE TRAILED INSERTS AND SETTLED ON A 10MM INSERT. IMPLANTS WERE ASSEMBLED AND IMPLANTED. IT WAS NOTED, THAT THE PATIENT HAD EXCELLENT RANGE OF MOTION AND STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20144080 ↗
• InjuryAug 21, 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 POSSIBLE INFECTION. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) POLY EXCHANGE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20018279 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COULD NOT GET FULL EXTENSION. KNEE FELT TOO TIGHT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE DOI- (B)(6) 2023. DOR- (B)(6) 2024; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity; Muscular Rigidity

  MAUDE report 19992407 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND POLY. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19950401 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF A PS RP INSERT FOLLOWING AN INFECTION. THE IMPLANTS WERE SOUND AND KNEE WAS OTHERWISE PERFORMING WELL. THE KNEE JUST BECAME BADLY INFECTED SO A WASH OUT AND INSERT EXCHANGE WAS REQUIRED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19837952 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 18987166 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA FOR BOTH KNEE JOINT. AFTER THE SURGERY, THE PATIENT WAS DOING WELL, BUT CAME TO THE HOSPITAL COMPLAINING OF DISCOMFORT MAINLY AROUND THE LEFT PATELLA. AFTER EXAMINATION WAS CONDUCTED, IT WAS CONFIRMED THAT THE PATIENT WAS INFECTED. ON (B)(6) 2024, CURETTAGE CLEANING AND INSERT REPLACEMENT AND PATELLA REVISION OF THE LEFT KNEE SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 18902207 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL COMPONENTS WERE REMOVED EXCEPT FOR THE PATELLA. REASON FOR REVISION WAS DUE TO INSTABILITY, PARTICULARLY MID FLEXION INSTABILITY. THEY HAVE HAD BOTH SIDES DONE, BUT WERE NEVER HAPPY WITH THIS SIDE. COMPONENTS WERE ALL WELL FIXED. SURGEON NOTED THAT THE TIBIAL SLOPE DID NOT LOOK RIGHT, AND THERE WAS ALSO BONE LEFT OUT THE BACK FROM THE PRIMARY TIBIAL RESECTION WHICH WAS NOT ADEQUATELY CLEARED. THEY WERE ALSO TIGHTER IN EXTENSION RELATIVE TO FLEXION, SO WAS NOT A BALANCED KNEE. DOI: (B)(6)2021 DOE: (B)(6)2024

  Patient problems: Joint Laxity

  MAUDE report 18852232 ↗
• 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 18757422 ↗
• MalfunctionFeb 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SPIKE OF THE INSERT PS OF ATTUNE WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 18675546 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA WITH THE IMPLANT IN QUESTION. ON AN UNKNOWN DATE, INFECTION WAS CONFIRMED. THEREFORE, A CURETTAGE CLEANING OF THE INFECTED AREA AND INSERT REPLACEMENT IS SCHEDULED FOR (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18541777 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH INSERT FOR INSTABILITY. DEBRIDEMENT OF SCAR TISSUE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2016, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 18325685 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TKA REVISION FOR PAIN AND INFLAMMATION. RIGHT KNEE. CEMENT NOT FROM DEPUY. DOI: (B)(6) 2020. DOR: (B)(6) 2023. RIGHT KNEE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT: (B)(6), WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: KNEE PAIN AND INFLAMMATION, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. (B)(6) 2023, REASON FOR REVISION SURGERY. KNEE PAIN AND INFLAMMATION, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? KNEE PAIN AND INFLAMMATION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE

  Patient problems: Inflammation; Pain

  MAUDE report 17806856 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ATTACHED MEDICAL RECORDS CAPTURE THE RESULTS OF THE PATIENT'S CARDIAC STRESS TEST AND ECHOCARDIOGRAM. IT ALSO CAPTURED THE OPERATIVE NOTES FOR HAND AND SHOULDER SOFT TISSUE REPAIRS, AND THE REMOVAL OF A COMPETITOR LEFT KNEE ORIF UNRELATED TO A DEPUY DEVICE. DOI (B)(6) 2015: FEMALE PATIENT RECEIVED A LEFT KNEE DEPUY ATTUNE TKA TO TREAT PAIN, STIFFNESS, AND END STAGE ARTHROSIS. THE NATIVE PATELLA WAS NOTED TO BE THIN AND RESURFACED AND DEPUY SMARTSET CEMENT X2 AND CMW CEMENT X1 WERE UTILIZED. THE SURGEON NOTES THE NATIVE PATELLA WAS VERY THIN REQUIRING ADDITIONAL CEMENT FOR SECURE FIXATION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PRIMARY PART/LOT IS PROVIDED ON PP. 211 OF THE MEDICAL RECORDS ENTITLED MEDICAL RECORDS AD (B)(6) 2024 (2). DOE: (B)(6) 2015: PATIENT RECEIVED A LEFT KNEE MUA WITH ARTHROSCOPIC LYSIS OF ADHESIONS TO TREAT PAIN, STIFFNESS, AND SWELLING SECONDARY TO ADHESIONS. UPON ENTERING THE JOINT, THE SURGEON PERFORMED A SYNOVECTOMY AND DEBRIDED ADHESIONS BEFORE PERFORMING THE MANIPULATION. THE SURGEON NOTES A PAIN PUMP WAS INSERTED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. (PP 331). DOR: (B)(6) 2016: PATIENT RECEIVED A LEF

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 17393459 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17333153 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INSTABILITY. WENT FROM A 5MM POLY TO A 10MM POLY. DOI: UNKNOWN. DOR: (B)(6) 2023. UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Laxity

  MAUDE report 17170186 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DATE(ONSET): (B)(6) 2022. ALERT DATE: (B)(6) 2022. . COUNTRY OF EVENT: OUS PROCEDURE: TKA USING ATTUNE CEMENTLESS: PS RP CONFIGURATION DATE OF PROCEDURE: (B)(6)2021 EVENT DESCRIPTION: RIGHT PERIPROSTHETIC TKA INFECTION. DATE OF EVALUATION: (B)(6) 2022. DATE OF SITE AWARENESS: (B)(6) 2022. OPERATIVE SIDE: RIGHT. DID THIS ADVERSE EVENT OCCUR INTRAOPERATIVELY?: NO DATE OF ONSET (OR WORSENING, IF APPLICABLE): (B)(6) 2022 IS THIS A NEW OR WORSENING EVENT?: NEW EVENT WAS THIS ADVERSE EVENT FOR THE STUDY KNEE?: YES WAS THIS ADVERSE EVENT CLASSIFIED AS SERIOUS?: YES LED TO DEATH: NO RESULTED IN A LIFE-THREATENING ILLNESS OR INJURY: NO RESULTED IN AN IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: YES REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT TO BODY STRUCTURE OR A BODY FUNCTION: YES LEADS TO FETAL DISTRESS, FETAL DEATH OR A CONGENITAL ABNORMALITY OR BIRTH DEFECT: NO WAS THE SUBJECT READMITTED TO HOSPITAL?: YES THE DATE OF READMISSION: (B)(6) 2022 THE DATE OF DISCHARGE: (B)(6) 2022 WAS EVENT EXPECTED/ANTICIPATED?: BLANK. SEVERITY: SEVERE. RELATION TO STUDY DEVICE:

  Patient problems: Unspecified Infection

  MAUDE report 17163361 ↗