ATTUNE 1516-30-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295047742), received between Dec 1, 2017 and Aug 26, 2026 — classified as 52 injuries.

The most frequently reported specific device problem is “Unintended Movement” (4 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that removal of CR Femur conversion to PS. Instability due to the patient falling.Affected side: Right knee.

  Patient problems: Fall; Joint Laxity

  MAUDE report 50452691 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2024, THE PATIENT UNDERWENT BILATERAL TKA FOR KNEE OA WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS REPORTED THAT AN INFECTION WAS IDENTIFIED IN THE RIGHT KNEE ONLY. ON (B)(6) 2026, IRRIGATION AND DEBRIDEMENT ALONG WITH INSERT REPLACEMENT WERE CONDUCTED. THE INSERT WAS REMOVED, THE SURGICAL SITE WAS THOROUGHLY IRRIGATED, AND A NEW INSERT WAS IMPLANTED. THE FEMORAL AND TIBIAL COMPONENT WAS NOT REVISED/EXPLANTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 25410912 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP TO A LARGER THICKNESS. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24305501 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND TORE EXTENSOR MECHANISM. SINCE THE DOCTOR HAD TO OPEN THE JOINT TO REPAIR THE TORN EXTENSOR, HE DECIDED TO DO A FULL WASH OUT AND POLY SWAP. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 24116122 ↗
• InjuryDec 31, 2025Adverse 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 FOR Q4 OF 2025. (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 FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23933957 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT FOR KNEE OSTEOARTHRITIS IN (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IN (B)(6) 2025, PAIN AND SWELLING IN THE AFFECTED AREA WERE CONFIRMED. THE SURGEON PLANS TO REPLACE THE INSERT WHEN DOING DEBRIDEMENT IN THE FUTURE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22002453 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. 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 PAIN. AT REMOVAL THERE WAS MINOR YELLOWING OF THE TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 21979027 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THREE KNEE REPLACEMENT DEVICE BY THREE MANUFACTURERS AND ALL THREE DEVICES FAILED. SO FAR PATIENT HAD TWO REVISIONS AND AWAITING A THIRD ONE. ON (B)(6) 2016, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY WITH DEPUY PRODUCTS. ON (B)(6) 2023, THE PATIENT HAD A REVISION OF THE RIGHT KNEE TO ADDRESS PAIN, LOOSE KNEE, "NEVER FELT RIGHT". ALL DEPUY COMPONENTS WERE REMOVED AND COMPETITOR PRODUCTS WERE PLACED AT THAT TIME. IT WAS FURTHER REPORTED THAT THE PATIENT'S LEFT KNEE WAS IMPLANTED WITH COMPETITOR PRODUCTS.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21231893 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD REVISION RTKA. PATIENT FELL SEVERAL MONTHS AGO AND HAS PAINFUL KNEE. THE TIBIA IMPLANT WAS COMPACTED DOWN MEDICALLY. REMOVED THE FEMORAL IMPLANT, TIBIAL IMPLANT AND INSERT. REVISED WITH ATTUNE REVISION KNEE SYSTEM. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 20200589 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON DID AN HAD IRRIGATION AND DEBRIDEMENT (I&D) OF THE KNEE. IN DOING SO, SURGEON DECIDED TO RETRIAL THE POLY AND DECIDED TO UPSIZE TO A 6MM. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18836614 ↗
• InjuryFeb 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY VIA TKA WITH THE IMPLANT IN QUESTION. THE IMPLANT IN QUESTION WAS REMOVED DUE TO INFECTION. ON (B)(6) 2024, THE SURGEON NOTED THAT THE IMPLANT IN QUESTION, WHICH HAD BEEN EXTRACTED IN THE PAST, WAS YELLOWISH. IT WAS ALSO NOTED THAT THE IMPLANT IN QUESTION MAY HAVE BEEN OXIDIZED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022 DOE: (B)(6) 2023

  Patient problems: Unspecified Infection

  MAUDE report 18712392 ↗
• InjuryDec 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGERY DELAY? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO DELAY TO SURGERY. B. IT MENTIONED THAT "PATIENT WAS TAKEN TO THEATRE FOR REVISION KNEE SURGERY. NUMBER 3 IMPLANT WAS REMOVED AND REPLACED." PLEASE CONFIRM WHAT IS THE NUMBER 3 IMPLANT. THIS STATEMENT IS INCORRECT. THE PATIENT WAS TAKEN TO THE THEATRE FOR A CLOSED REDUCTION. THERE WAS NO OPEN SURGERY REQUIRED. THE PATIENT HAS BEEN IMMOBILIZED IN A CAST FOR 6 WEEKS. C. PLEASE PROVIDE THE EXPLANT DATE. THERE IS NO EXPLANT DATE AS THE IMPLANT WAS NOT REMOVED.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 18300608 ↗
• InjuryNov 21, 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: UNKNOWN; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18184469 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DPO_14022 CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS OF THE LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2018. (LEFT KNEE) TREATMENT: I&D, SYNOVECTOMY, ARTHROLYSIS AND PHYSICAL THERAPY.

  Patient problems: Adhesion(s)

  MAUDE report 18004944 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXCHANGE OF TIBIAL INSERT DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17333299 ↗
• InjuryJun 6, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT RETURNED TO THEATRE WITH DISLOCATED TOTAL KNEE REPLACEMENTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17070827 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17058759 ↗
• InjuryMay 17, 2023Unintended Movement; Unintended Movement

  SURGEON PREFORMED TOTAL KNEE REPLACEMENT USING ATTUNE CEMENTLESS RP IMPLANTS. POST OP X-RAY SHOWED POST/LATERAL SPIN OUT. SURGEONS ARE INVESTIGATING TO AMEND SURGICAL WORK FLOW TO HELP REDUCE THE RISK OF FUTURE SPIN OUT.

  Patient problems: Insufficient Information

  MAUDE report 16945506 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16598225 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D POLY SWAP WAS PERFORMED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16494641 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "DARTMOUTH BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 30.3 MONTHS. REASON FOR REVISION: INSTABILITY/PAIN."

  Patient problems: Joint Laxity; Pain

  MAUDE report 16378692 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DARTMOUTH BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 24.5 MONTHS. REASON FOR REVISION: INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 16333951 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD REVISION KNEE REPLACEMENT FOR PAIN & STIFFNESS. ATTUNE PRIMARY REVISED AND REPLACED WITH ATTUNE REVISION ON (B)(6) 2022. PATIENT HAD ORIGINAL PRIMARY SURGERY IN 2018. AFTER INITIAL PRIMARY SURGERY PATIENT HAD KNEE STIFFNESS WITH LIMITED FLEXION (<90 DEGREES). HAD MULTIPLE (X4) MUA'S (MANIPULATION UNDER UNAESTHETIC) WHICH DID NOT FIX THE ISSUE OF STIFFNESS. X-RAY SHOWED SOME SIGNS OF POSSIBLE TIBIAL LOOSENING (LUCENT LINES & SUBSIDENCE). DURING REMOVAL OF PRIMARY IMPLANTS IN REVISION SURGERY IT WAS NOTED THAT THE FEMUR WAS WELL FIXED BUT WAS SITTING SOMEWHAT ANTERIOR (PATELLO FEMORAL STUFFING CONTRIBUTING TO STIFFNESS) HOWEVER THE TIBIA WAS SOMEWHAT LOOSE PARTICULARLY ANTERIORLY. FEMUR, TIBIA & INSERT REMOVED. FEMUR DOWNSIZED TO A SIZE 4 TO OPEN FLEXION GAP. FLEXION EXTENSION GAPS EQUALIZED. RP STEMMED FEMORAL & TIBIAL COMPONENT USED WITH POSTERIOR STABILIZED INSERT. KNEE RANGE OF MOTION WAS PAST 90 DEGREES. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO. 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

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 15131576 ↗
• InjuryJul 8, 2022Unintended Movement; Unintended Movement

  PATIENT HAS HAD A CR RP POLY SPIN 1 DAY POST -OP. PT IS BOOKED FOR AN MUA {DATE REDACTED} AT 6PM +/- POLY CHANGE. NO UNUSUAL ISSUES DURING INDEX PROCEDURE WITH A WELL BALANCED KNEE DURING PROCEDURE. WE JUST DID A CLOSED REDUCTION OF THE POLY. NO IMPLANTS WE REVISED FOR THIS CASE.

  Patient problems: Insufficient Information

  MAUDE report 14955523 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FAILED RIGHT TOTAL KNEE ARTHROPLASTY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014; DATE OF EVENT (ONSET): 03/01/2022; (RIGHT KNEE). TREATMENT: ON (B)(6) 2022, PATIENT'S RIGHT KNEE FEMUR, TIBIAL TRAY, AND TIBIAL INSERT COMPONENTS WERE REVISED; PATELLA COMPONENT WAS RETAINED.

  Patient problems: Insufficient Information

  MAUDE report 14454128 ↗