ATTUNE 1517-10-712Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295056157), received between Oct 11, 2021 and Sep 25, 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.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient had an infection. Surgeon performed a debridement, washout and poly swap.DOI- (b)(6) 2023.DOR- (b)(6) 2026.Affected side- Right.

  Patient problems: Unspecified Infection

  MAUDE report 50900147 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLY SWAP WAS PERFORMED FOR INSTABILITY. PATIENT HAD EXPERIENCED GLOBAL LAXITY OF HER SOFT TISSUE. MUCH LARGER POLYETHYLENE INSERT WAS NEEDED. NO SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25461645 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS END-STEM PAIN ON TIBIA. SO IT WAS REVISED TO SHORTER THE STEM. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23095565 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A STRYKER TKA REMOVED ON (B)(6) 2025, AND SURGEON IMPLANTED AN ATTUNE RP REVISION, PATIENT DID NOT HEAL AND SURGEON THOUGHT IT WAS INFECTED. SURGEON DID A POLY EXCHANGE AND WASH OUT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 23089156 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALL. I&D WITH LINER EXCHANGE WERE PERFORMED. THERE WAS NO COMPLAINTS WITH IMPLANT AND NO DELAY. DOI: (B)(6) 2025 DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 23026979 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D WITH LINER EXCHANGE WAS PERFORMED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22038889 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO DELAYS OR ADVERSE EVENTS.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 21873026 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP AND WASHOUT FOR POTENTIAL INFECTION PERFORMED THURSDAY EVENING. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20235512 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A KNOWN STAPH EPI INFECTION. ALL COMPONENTS WERE REMOVED. THERE WAS NO SURGICAL DELAYS. THERE WAS NO PATIENT CONSEQUENCES. NO PARTS WERE BROKEN. LOT NUMBERS WERE NOT VISIBLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19764520 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A KNOWN INFECTION, AND I&D WITH POLY EXCHANGE WAS PERFORMED. THERE WERE NO DELAYS AND NO BROKEN INSTRUMENTS. THE LOT NUMBER WAS READ FROM THE FIELD. NO DEFICIENCIES WERE REPORTED. DOI: (B)(6) 2021. DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19553508 ↗
• InjuryJun 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 19442949 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED, DUE TO KNEE BEING UNSTABLE. THE SURGEON DID POLY SWAP. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19259276 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH I&D POLY EXCHANGE. THERE WAS NO SURGICAL DELAYS AND NO HARM TO PATIENT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18640656 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION CRS POLY IN AND BECAME INFECTED. THE DOCTOR IRRIGATED AND CLEANED OUT THE KNEE, REMOVED THE POLY, AND PUT IN A NEW ONE. ANTIBIOTIC BEADS WERE ALSO PLACED IN THE KNEE AFTER THE NEW POLY WAS PUT IN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18525959 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR POSSIBLE INFECTION AND POLY WAS UPSIZED. UNABLE TO REPORT ON INFECTION. DATE AND LOCATION OF PREVIOUS SURGERY IS UNKNOWN. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16131378 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTED KNEE. DID A POLY EXCHANGE. IMPLANTED A 1517-10-718. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15563750 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED KNEE DUE TO PATIENT DISCOMFORT, HE ALSO FELT THE KNEE WAS UNSTABLE. TIBIA SEEMED TO COME OUT EASIER THAN MOST, NOT SURE IF IT WAS LOOSE OR UNDERSIZED. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 15475134 ↗
• InjuryOct 11, 2021Unintended Movement; Unintended Movement

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE INFECTION OCCURRED AFTER THE SURGERY AND THE 1ST REVISION SURGERY DUE TO INFECTION. THIS PC REPORTS ABOUT THE SPIN-OUT OF THE INSERT OCCURRED AFTER THE 1ST REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT THE SURGERY FOR KNEE. AFTER THE SURGERY, INFECTION OCCURRED. AFTER THE INFECTION HAD SUBSIDED, ON (B)(6) 2021, THE 1ST REVISION SURGERY (TKA) WAS PERFORMED. AFTER THE 1ST REVISION SURGERY, ON (B)(6) 2021, THE SPIN-OUT OF THE INSERT OCCURRED. ON (B)(6) 2021, THE 2ND REVISION SURGERY WILL BE PERFORMED TO REPLACE THE INSERT IN QUESTION TO ANOTHER THICKER INSERT. EVEN AFTER THE OCCURRENCE OF SPIN-OUT, THE PATIENT HAS NO PAIN AND ONLY FEELS STRANGE. THE SURGEON COMMENTED THAT SINCE THE RANGE OF MOTION WAS GOOD AT 130 DEGREES, THERE WAS A HIGH POSSIBILITY OF SPIN-OUT DURING DEEP FLEXION. DOI: (B)(6) 2019. 1ST DOR: (B)(6) 2021. 2ND DOR: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12605719 ↗