ATTUNE 1516-30-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295047629), received between Aug 9, 2017 and Aug 17, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Unintended Movement” (5 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.

• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  The patient was revised due to instability.Affected side: Right Knee.

  Patient problems: Joint Laxity

  MAUDE report 50275531 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CR RP INSRT SZ 4 5 MM, ATTUNE CR FEM RT SZ 4 CEM, AND ATTUNE RP TIB BASE SZ 3 CEM WERE INVOLVED IN A REPORTED EVENT FOLLOWING KNEE SURGERY. THE EVENT CONCERNED A POSSIBLE ALLERGIC REACTION EXPERIENCED BY A PATIENT MORE THAN ONE YEAR AFTER IMPLANTATION OF THE ATTUNE PROSTHESIS. THE PATIENT CONSEQUENCE WAS DESCRIBED AS A POTENTIAL ALLERGIC REACTION, CLASSIFIED AS A MINOR INJURY, AND NO DEVICE MALFUNCTION WAS ALLEGED. THERE WAS NO REMOVAL OF THE IMPLANTS, AND THE DEVICES REMAIN WITH THE CUSTOMER, NOT AVAILABLE FOR RETURN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25373799 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GRADUALLY BECAME LESS STABLE. WENT UP FROM A 5MM TO 10MM POLY. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24429202 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSTERIOR SUBLUXATION OF KNEE DONE IN (B)(6). DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23544330 ↗
• InjuryAug 20, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE IMPLANT WAS UNDERSIZED AND UNUSABLE. THE SURGEON INCREASED THE SIZE BY 3MM TO 8MM. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22848992 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THE SURGEON MENTIONED THAT IF THE PATIENT¿S PAIN PERSISTED IN THE FUTURE, HE PLANNED TO REMOVE ALL THE IMPLANTS AND PERFORM REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 21354968 ↗
• InjuryJan 3, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TKA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, SPIN-OUT WAS CONFIRMED DURING INPATIENT CONSULTATION. A REVISION SURGERY WAS PERFORMED. THE CR WAS REPLACED WITH PS. THE INSERT WAS CHANGED FROM 5MM TO 12MM.

  Patient problems: Insufficient Information

  MAUDE report 21072087 ↗
• InjuryDec 30, 2024Adverse 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 10 FOR Q4 OF 2024. (B)(6) H 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 INFECTION AND INSTABILITY. THE TIBIAL INSERT SHOWED POSTERIOR IMPINGEMENT AT REVISION.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 21034933 ↗
• InjuryDec 27, 2024Adverse 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 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 INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21028577 ↗
• InjuryJun 3, 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 PAIN. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19447652 ↗
• InjuryMay 13, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY VIA TKA WITH THE INSERT IN QUESTION. THE INSERT IN QUESTION SPUN OUT ON (B)(6) AND WAS PUT BACK IN PLACE, BUT THE INSERT WAS REPLACED ON (B)(6). REGARDING THE CAUSE OF THE SPIN-OUT, THE SURGEON MENTIONED THAT THE 5MM INSERT WAS PLACED LOOSELY DURING THE PRIMARY SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19303262 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF RIGHT TOTAL KNEE. POLY EXCHANGE PERFORMED. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19080467 ↗
• InjuryFeb 7, 2024Adverse 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) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18658705 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INSTABILITY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022 DOR: NOV 20, 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18247961 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 18236786 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT TOTAL KNEE WAS INFECTED. I&D, WASHOUT AND POLY EXCHANGE WAS PERFORMED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6), 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17360567 ↗
• InjuryApr 28, 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 16833316 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(6) 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 15.6 MONTHS. REASON FOR REVISION: PAIN.

  Patient problems: Pain

  MAUDE report 16364050 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR BEING UNSTABLE. WENT UP TO A THICKER POLY SIZE. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16185804 ↗
• InjuryDec 22, 2021Adverse 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 TKA SURGERY FOR BOTH KNEES WITH THE INSERT IN QUESTION. AFTER THE SURGERY, ON AN UNKNOWN DATE, THE PATIENT COMPLAINED OF LEFT KNEE PAIN AND DISCOMFORT. ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY TO REMOVE PERIARTICULAR SCAR TISSUE (DEBRIDEMENT) AND INSERT REVISION. THE SURGEON SELECTED A THICKER IMPLANT THAN THE ONE USED IN THE INITIAL SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Discomfort; Pain; Scar Tissue

  MAUDE report 13060455 ↗
• InjurySep 27, 2021Adverse 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 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 12532209 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A PRIMARY RIGHT ATTUNE TKA TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN AND DISCOMFORT. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED ADHESIONS AS WELL AS SIGNIFICANT TIGHTNESS OF THE PATELLAR TENDON EXTENSOR MECHANISM. THE FEMORAL COMPONENT AND TIBIAL TRAY WERE REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED AFTER THE SURGEON DEBRIDED PERIPATELLAR SYNOVITIS AND ADHESIONS. THE SURGEON PERFORMED A LATERAL PATELLA TENDON RELEASE WITH PEELING TO TREAT THE EXTENSOR MECHANISM TIGHTNESS. THE PATIENT WAS REVISED WITH A DEPUY REVISION TC3 CONSTRUCT. AFTER REMOVAL OF THE PRIMARY ATTUNE PRODUCTS, THE PATIENT SUSTAINED A TIBIAL CONDYLAR FRACTURE DURING TIBIAL RESECTION. THERE WERE NO ADDITIONAL DEVICES USED TO TREAT THE FRACTURE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain; Synovitis

  MAUDE report 11618488 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A PRIMARY RIGHT ATTUNE TKA TO TREAT SEVERE ADVANCED OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE PAIN SECONDARY TO ASEPTIC LOOSENING. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED FEMORAL ADHESIONS. THERE WAS SIGNIFICANT FEMORAL OSTEOLYSIS SURROUNDING THE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS LOOSENED AT THE CEMENT TO BONE INTERFACE AND REVISED. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WERE ADHESIONS ON THE PATELLA BUTTON AND THE PATELLAR BUTTON WAS REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT WAS REVISED WITH A COMPETITOR KNEE REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Adhesion(s); Osteolysis; Pain

  MAUDE report 11615287 ↗
• 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 11603319 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11179090 ↗