ATTUNE 1517-10-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295056133), received between Jun 13, 2019 and Nov 3, 2025 — 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.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. PERFORMED I&D POLY SWAP. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23453410 ↗
• InjuryOct 29, 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 INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23413326 ↗
• InjuryJul 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 INFECTION. POLY SWAP WAS DONE. DOI: (B)(6) 2025, DOR: UNKNOWN, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22543106 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY SWAP DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22286001 ↗
• InjuryJun 16, 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 INFECTION. I&D WITH POLY EXCHANGE WAS PERFORMED. THERE WERE NO ADVERSE EVENTS. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22215463 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE WASHOUT AND POLY SWAP DUE TO INFECTION. NO OTHER PRODUCTS WERE REVISED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22104737 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND POLY SWAP WAS BEING PERFORMED DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22053763 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST KNEE REPLACEMENT, AND HAD A PERIPROSTHETIC FRACTURE. IN A SEPARATE SURGERY, THEY ADDED A DISTAL FEMUR CONDYLAR PLATE. PATIENT FELL AGAIN, AND BROKE PROXIMAL TO THE PLATE. THE PLAN WAS TO REMOVE THE FEMUR, AND USE A DISTAL FEMUR REPLACEMENT. HOWEVER THE PATIENT HAS AN ACTIVE KNEE INFECTION, AND PUSS WAS IN THE SURGERY SITE. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 21962846 ↗
• InjurySep 24, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE POLY DISLOCATED FOLLOWING INITIAL REVISION. SURGEON REMOVED THE POLY AND REPLACED WITH A NEW ONE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 20290810 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH WELL ALIGNED, APPROPRIATELY SIZED REVISION TOTAL KNEE WITH THE JOINT LINE IN A GOOD POSITION. NO COMPONENTS ARE LOOSE HOWEVER PATIENT COMPLAINS OF PAIN AND INSTABILITY. NO POLY WEAR IS NOTED AND SURGEON BELIEVES THE PATIENT HAS STRETCHED OUT OVER TIME. A THICKER INSERT IS PLACE WITHOUT COMPLICATION AND NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17172970 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D OF KNEE WITH LINER EXCHANGE WAS DONE TO PREVENT INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16853032 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFF RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE) . TREATMENT: SURGICAL RIGHT KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 10957846 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, SWELLING, AND REDUCED MOTION. THE SURGEON PERFORMED POLY SWAP AND DEBRIDEMENT. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10600691 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A SIGNIFICANT AMOUNT OF HYPER EXTENSION AND THE POLY SIZE NEEDED TO BE UPSIZED SIGNIFICANTLY TO STABILIZE THE KNEE. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10503176 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE WAS DONE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10251698 ↗
• InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10018451 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REVISION TOTAL KNEE DONE ELSEWHERE. CAME IN WITH INFECTION. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS INSERTED. DOI: (B)(6) 2019; DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9848640 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS DRAINING WOUND AND BELIEVED TO BE INFECTED. ALL COMPONENTS WERE REMOVED AND AN CEMENT SPACER WAS IMPLANTED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8697359 ↗