ATTUNE 1517-10-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295056140), received between Jan 13, 2020 and Aug 19, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  The patient had a poly swap performed for infection.DOI: (b)(6) 2023.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50327226 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS REVISION THAT BECAME INFECTED. PATIENT HAD AN OPEN WOUND AND SO PRIOR TO DOING A SKIN GRAFT, THE SURGEON DID A POLY EXCHANGE. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 23295948 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT IMPLANT REMOVAL DUE TO INFECTION. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22730704 ↗
• InjuryJul 25, 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) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22612723 ↗
• InjuryJul 25, 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) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22612714 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE DONE IN (B)(6) 2024. IT WAS DISLOCATED AND NEEDED TO BE REVISED FOR STABILITY. THE PATIENT HAD AN ATTUNE REVISION FEMUR WITH SLEEVE AND STEM. THE TIBIA WAS AN ATTUNE REVISION ROTATING PLATFORM WITH SLEEVE AND STEM. THE FEMORAL COMPONENT, FEMORAL SLEEVE AND STEM WERE EXTRACTED AND THE PATIENT WAS CONVERTED TO AN SROM HINGE FEMUR WITH UNIVERSAL SLEEVE AND UNIVERSAL STEM, ALONG WITH A BRIDGING BEARING. THE ATTUNE REVISION TIBIAL TRAY/SLEEVE/STEM CONSTRUCT WAS NOT REVISED. 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: LEFT KNEE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21328494 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME IN TODAY FOR WASHOUT. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) OF TOTAL KNEE AND POLY INSERT EXCHANGE. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20200214 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATES THAT NO HARM/CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 20086761 ↗
• InjurySep 27, 2023Adverse 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) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17825617 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) OF TOTAL KNEE AND DID A POLY EXCHANGE FOR UNKNOWN REASON. DOI- (B)(6) 2020 DOR; (B)(6) 2023 ;AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17825383 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, A DEBRIDEMENT WAS DONE AND AFTER A TRIAL A CRS RP SZ7 X 12 MM WAS IMPLANTED. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17710541 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AFFECTED SIDE WAS THE RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 17564075 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LACK OF RANGE OF MOTION. DOWNSIZED FROM A 10MM POLY TO 6MM. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 16742419 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPSIS (STREP B) AND LOOSENING OF THE FEMORAL, SLEEVE AND STEM AT THE CEMENT TO BONE INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis

  MAUDE report 14688690 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT 1ST OF TWO STAGE PROCEDURE ON (B)(6) 2021 WHERE AN ATTUNE CR FEMUR AND INSERT WERE UTILISED AS A KIWI SPACER. THIS WAS DUE TO INFECTION OF THE PRIMARY TKR - NON DEPUY. THIS KIWI SPACER WAS REMOVED ON (B)(6) 2021 AND AN ATTUNE REVISION IMPLANTED. PATIENT HAS DONE WELL BUT HAS RECENTLY PRESENTED WITH A SWOLLEN AND PAINFUL KNEE. A DECISION WAS MADE TO OPEN THE KNEE, PERFORM A WASHOUT AND EXCHANGE THE BEARING. THE KNEE WAS OPENED, INFECTED FLUID WAS EVIDENT. THIS KNEE HAS PREVIOUSLY GROWN GRAM POSITIVE CULTURE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, DOE: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13949512 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PREVIOUS LEFT TOTAL KNEE REVISION WITH ATTUNE REVISION SYSTEM AND PRESENTED WITH A STIFF LEFT KNEE FOLLOWING REVISION. SURGEON REMOVE POLYETHYLENE AND PERFORMED A SYNOVECTOMY. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2021 , LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 13167782 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A POLY SWAP AND A WASHOUT WERE PERFORMED. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11841537 ↗
• InjuryJan 13, 2020Unintended Movement; Unintended Movement

  THE PATIENT WAS REVISED TO ADDRESS FALL ON POST 2ND STAGE SURGERY FOR INFECTED KNEE AND RUPTURED PATELLAR TENDON. THERE WAS A POSSIBLE RP SPIN OUT AFTER A FALL. PATELLAR TENDON WAS REPAIRED AND INSERT WAS EXCHANGED TO 16 MM FROM 10 MM AT REVISION. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9582051 ↗