ATTUNE 1517-10-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295056027), received between Aug 15, 2018 and Aug 11, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (1 report).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  The patient was revised due to infection. A poly swap was performed.DOI: (b)(6) 2021.DOR: (b)(6) 2026.Affected side: Right Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50209519 ↗
• InjuryJul 21, 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 INFECTED RIGHT KNEE. SPACER PLACEMENT WAS DONE. NO SURGICAL DELAY WAS REPORTED. AFFECTED SITE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22556581 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP FOR THE SAME SIZE DUE TO INFECTION. NO HARM TO THE PATIENT. NO DELAY IN THE CASE AND NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21145343 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH POLY EXCHANGED DUE TO INFECTION. THE SURGEON PERFORMED I & D. THERE WAS NO DELAYS, NO HARM TO PATIENT, NO BROKEN INSTRUMENT. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20682642 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20589011 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. THEREFORE THE STAFF DID A WASHOUT AND A POLY SWAP. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20345028 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND UNSTABLE. DOI: UNKNOWN. DPR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20279649 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INSTABILITY. FEMORAL COMPONENT AND POLY WERE REMOVED AND REPLACED WITH LPS COMPONENTS. THERE WAS NO LOSS OF CASE TIME. DOI: (B)(6), 2021. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19567707 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH A WASHOUT POLY EXCHANGE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17806777 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION OF AN UNKNOWN ORIGIN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17153573 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 16264874 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE THE REVISION REPORTED IN (B)(4) (DETAILS RECEIVED FROM ADDITIONAL INFORMATION RECEIVED FROM (B)(4)- UPLOADED AS SOURCE DATA). PRIMARY SURGERY NON DEPUY PRODUCTS. 1ST REVISION (NON DEPUY PRODUCTS FROM PRIMARY REMOVED). 2ND REVISION REVISION FOR POLY EXCHANGE (REPORTED IN (B)(4)).

  Patient problems: Loss of Range of Motion

  MAUDE report 16120395 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION, ATTUNE SPACER PUT IN ITS PLACE. IMPLANTS RETAINED BY HOSPITAL. NO OTHER CONSEQUENCES TO PATIENT. PRIMARY SURGERY DATE IS UNKNOWN, FIRST REVISION SURGERY DATE ON (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15873716 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MEDICAL RECORDS FROM (B)(6) 2022 NOTED THAT THE PATIENT HAD A LEFT TOTAL KNEE REVISION COMPLETED ON (B)(6) 2022. AFTER THE REVISION, THE PATIENT HAD ERYTHEMA OVER THE INCISION AND A STITCH ABSCESS WAS CUT OUT. PATIENT REPORTS HAVING PAIN DUE TO THE SUPERFICIAL INFECTION". NOTE: THE PATELLA WAS LEFT IN SITU DURING (B)(6) 2022 REVISION.

  Patient problems: Abscess; Erythema; Pain; Unspecified Infection

  MAUDE report 15257768 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATCH OF SYNOVITIS LATERAL ASPECT OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2021. (LEFT KNEE). TREATMENT: INJECTED MEDICATION; DIAGNOSTIC INTERVENTION.

  Patient problems: Synovitis

  MAUDE report 15198815 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT ANKLE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2022. RIGHT KNEE. TREATMENT: INJECTED MEDICATION.

  Patient problems: Pain

  MAUDE report 15012678 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PAINFUL RIGHT KNEE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14602961 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13892207 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATCH OF SYNOVITIS LATERAL ASPECT OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2018, DATE OF EVENT: (B)(6) 2021, (LEFT KNEE). TREATMENT: UNSPECIFIED INJECTED MEDICATION AND DIAGNOSTIC INTERVENTION.

  Patient problems: Synovitis

  MAUDE report 12786702 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE STIFFNESS EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: SURGICAL INTERVENTION - MANIPULATION OF RIGHT KNEE UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 11633685 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. POLY SWAP WAS DONE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; UNK AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10105701 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10104208 ↗
• MalfunctionAug 15, 2018Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  CUSTOMER IS COMPLAINING THE STERILE PACKAGE OF ATTUNE INLAY. THE COVER IS VERY HARD TO REMOVE/LIFT AS THERE IS NO POSSIBILITY TO GRASP IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785098 ↗