ATTUNE 1518-10-041Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 10603295056652), received between Aug 7, 2017 and Jun 22, 2026 — classified as 72 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REPORTED DEVICE WAS EXPLANTED FOR INFECTION, ABX SPACER PLACED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25578412 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24307927 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23853749 ↗
• InjurySep 18, 2025Adverse 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. AFFECTED SITE - LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23082210 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION STAGE 1/2. NO DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22895990 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN RIGHT ATTUNE TOTAL KNEE REPLACEMENT WHICH WAS DONE (B)(6) 2024. REASON FOR REVISION IS DUE TO INFECTION. COMPONENTS WERE WELL FIXED DESPITE THE DEEP INFECTION. THE SURGEON COMMENTED HOW WELL FIXED THE TIBIAL SLEEVE WAS. ALL COMPONENTS WERE REMOVED. PATIENT HAD A UKR PREVIOUSLY WHICH WAS LOOSED AND WAS REVISED TO THIS. DEPUY PRODUCTS WERE NOT USED IN THE UKR THE SITE WAS DEEMED AS NOT INFECTED AT THE TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22838351 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS REMOVED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22232224 ↗
• InjuryMay 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF PATELLA AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS DEPUY SYNTHES. PATIENT HAD LOOSE PATELLA AND FEMUR. ALL IMPLANTS WERE REMOVED AND RP CRS CONSTRUCT WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22059704 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE AN INFECTION. SO, SURGEON PULLED ORIGINAL IMPLANTS AND PUT IN A CEMENT SPACER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21936303 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21878217 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 INCLUDING PATELLA RESURFACING USING COMPETITOR CEMENT. THE PRIMARY OPERATION DID NOT HAVE ANY INTRAOPERATIVE ISSUES. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT KNEE REVISION FOR SYMPTOMS OF JOINT INSTABILITY, DIFFICULTY WALKING AND PAIN. INTRAOPERATIVELY THE SURGEON STATES BOTH FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE SURGEON DID REQUIRE AN IMPACTOR AND MALLET TO REMOVE BOTH COMPONENTS. THE TIBIAL TRAY HAD ALSO SUBSIDED MEDIALLY. AS THE SURGEON WAS REMOVING THE PATELLAR COMPONENT, HE NOTED THERE WAS HETEROTOPIC BONE LATERALLY THAT WAS REMOVED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Pain

  MAUDE report 21775619 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. THERE WAS NO LOOSENING OF IMPLANTS. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN; DOR: (B)(6) 2025; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 21351233 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20532647 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR: DID SUBJECT REPORT ANY NEW AES OR ANY UPDATES TO AN EXISTING AE AT THIS EVALUATION?: YES. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: NO INFORMATION PROVIDED, DATE OF IMPLANT: NO INFORMATION PROVIDED, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: KNEE; NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO REMOVAL/EXCHANGE/REVISION. ADDITIONAL EVENT INFORMATION. CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: (B)(6) 2019, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT KNEE. TREATMENT/IMPACT: ASPIRATION/DRAINAGE; RECOVERED/RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2019.

  Patient problems: Swelling/ Edema

  MAUDE report 20332952 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION. DEVICE (RELATEDNESS): POSSIBLY. PROCEDURE (RELATEDNESS): POSSIBLY. DATE OF EVENT: 29 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: BLANK. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 20293206 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFF KNEE. REVISES THE PATELLA AND DOWN SIZED THE POLY. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 19340545 ↗
• MalfunctionMar 20, 2024Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATELLA PACKAGING WAS RIPPING WHILE ATTEMPTING TO OPEN IMPLANT TO FIELD. THE STAFF WAS NOT COMFORTABLE WITH USING AND ASKED FOR ANOTHER PATELLA TO BE OPENED. THERE IS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941766 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18796719 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18629175 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL, AND KNEE BECAME INFECTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 18608882 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INCREASING PAIN AND INSTABILITY AND PATELLA AND TIBIAL REVISION WAS PERFORMED. THE TIBIA WAS LOOSE AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2015. DOR:(B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18596743 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A LEFT KNEE REVISION AND PLACEMENT OF SPACER DUE TO INFECTION. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17748067 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A INFECTED JOINT. IMPLANTS WERE REMOVED, JOINT WAS WASHED OUT, I&D, CRS FEMUR AND RP CRS INSERT WERE IMPLANTED AS A SPACER. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17165204 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO THE PRESENCE OF INFECTION. THE ATTUNE TOTAL KNEE CONSTRUCT WAS REMOVED AND ARTICULATING ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16806804 ↗
• InjuryApr 5, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSE PATELLA; MALROTATION ON TIBIAL COMPONENT. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS REPORTED UNKNOWN. DOI: (B)(6). DOR: (B)(6). AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16682244 ↗