ATTUNE 1517-10-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295055822), received between Feb 12, 2020 and Mar 30, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED JOINT INSTABILITY FOLLOWING TOTAL KNEE ARTHROPLASTY REVISION, ATTRIBUTED TO MEDIAL COLLATERAL LIGAMENT (MCL) INSUFFICIENCY. THE SURGEON DETERMINED THAT A HINGE PROSTHESIS WOULD BE REQUIRED TO RESTORE STABILITY. FEMORAL SIDE COMPONENTS WERE REMOVED AND A DISTAL FEMORAL PROSTHESIS WAS PLACED WITHOUT DELAY OR HARM. ALL COMPONENTS WERE WELL FIXED AND PERFORMED AS EXPECTED BUT COULD NOT SUPPORT THE LOSS OF STABILITY POST MCL INSUFFICIENCY. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 24729864 ↗
• InjuryMar 26, 2026Fracture; Device Dislodged or Dislocated

  THE POLY INSERT WAS REMOVED FROM A PATIENT ON (B)(6) 2026 AFTER ORIGINALLY BEING IMPLANTED ON (B)(6) 2025. AS SEEN IN THE XRAYS THE FEMUR HAD THEN DISLOCATED FROM THE INSERT IN THE WEEKS FOLLOWING. DURING THE REVISION PROCEDURE ONCE THE KNEE WAS OPENED UP, IT BECAME CLEAR THAT THE POST HAD SNAPPED AT THE TOP OF THE INSERT, UPON MANIPULATION OF THE ARTICULATING SURFACE SOMETHING SEEMED NOT QUITE CORRECT AND THE POST WAS FITTING TOO SNUG IN THE BOX IN THE FEMUR. ALL SIZES WERE CHECKED (AGAINST NJR, WRITTEN ON THE IMPLANTS & ALSO MEASURED WITH CALIPERS) AND COMPATIBLE/CORRECT.

  Patient problems: Joint Dislocation

  MAUDE report 24699742 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT INFECTED, POLY SWAP, DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24495430 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH IRRIGATION AND DEBRIDEMENT DUE TO SUSPECTED INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23019332 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR WASHOUT AND POLY WAS EXCHANGED. 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: Insufficient Information

  MAUDE report 22013044 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STEM PAIN FROM PRIOR REVISION. TIBIA WAS REVISED. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 20461873 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION WHICH CAUSED FEMUR TO LOOSEN. THERE WAS FEMORAL LOOSENING AT THE BONE AND CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20182132 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS RE-IMPLANTED FOLLOWING THE REMOVAL OF AN ANTIBIOTIC SPACER. PATIENT FELL WHEN THEY GOT HOME THE NEXT DAY CAUSING THE MCL TO BE COMPROMISED. PATIENT WAS BROUGHT BACK FOR SURGERY AND ALL FEMORAL COMPONENTS WERE REMOVED AND A SROM HINGE WAS PLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19761802 ↗
• InjuryJul 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. C. PLEASE CLARIFY IF THIS IS IMPLANT LOOSENING OR JOINT INSTABILITY? JOINT INSTABILITY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19711405 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A WASHOUT AND ATTUNE REVISION POLY WAS EXCHANGED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18056264 ↗
• InjuryApr 10, 2023Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  THE PREVIOUSLY IMPLANTED IMPLANTS DIDN¿T DELIVER ENOUGH STABILITY FOR THIS CASE. DOI: (B)(6) 2023 DOR: (B)(6) 2023 UNKNOWN SIDE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707265 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO POSTOPERATIVE PAIN AND INSTABILITY OF THE ATTUNE REVISION RP INLAY, THE FEMORAL COMPONENTS HAD TO BE REVISED TO AN S-ROM HINGED PROSTHESIS.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16632894 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. POLY WAS EXCHANGED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16246810 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SKIN FLAP DIED SHORTLY AFTER INITIAL REVISION. SURGEON PREFERENCE TO DO A DEBRIDEMENT AND SWAP THE POLY IN RESPONSE TO POSSIBLE INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 11558753 ↗
• InjuryDec 3, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2020, UNKNOWN SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 10942952 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE POLY EXCHANGE WAS PERFORMED. NO ADDITIONAL INFORMATION. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9699637 ↗