ATTUNE 1516-50-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10603295052739), received between Aug 21, 2017 and Sep 9, 2026 — classified as 72 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient fell. Possible infection I&D of knee Poly swap. There was no complications.DOI: (b)(6), 2026DOR: (b)(6) 2026Affected Side: Right Knee

  Patient problems: Unspecified Infection

  MAUDE report 50693369 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an instability that led to a revision procedure in which the insert was replaced with a different polyethylene component.DOI-(b)(6) 2024DOR-(b)(6) 2026 Affected side-Right

  Patient problems: Joint Laxity

  MAUDE report 50591662 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had an infection, so the surgeon did a washout and swapped the polyethylene tibial insert.DOI: (b)(6) 2024.DOR :(b)(6) 2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50071481 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REPORTS THE PATIENT CAME TO HIS CLINIC WITH A TORN PATELLA TENDON AND REPORTS HE FELL LAST (B)(6), LANDING ON HIS KNEE AND HAS PROBLEMS EVER SINCE. SURGEON SWAPPED THE SZ 7 X 8MM ATTUNE PS RP POLY FOR 7MM POLY AND REPAIRED THE TIBIAL PATELLAR TENDON. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 25575720 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, I&D WAS PERFORMED WITH POLY SWAP. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24210525 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 24067498 ↗
• InjurySep 11, 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 INSTABILITY. THE SURGEON DECIDED TO PUT IN A THICKER POLY AND PUT IN A NEW PATELLA TO HELP WITH TRACKING. NO MENTIONED ANYTHING WRONG WITH THE IMPLANTS. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23031913 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON BROUGHT THE PATIENT TO SURGERY FOR INSTABILITY IN THE KNEE. BELIEVED THAT PATIENT TORE THEIR MCL. WENT UP IN POLY SIZE AND THROUGH TRIALING DECIDED IN A 12MM FOR BETTER STABILITY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 23026729 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR WOUND DEHISCENCE WITH IRRITATION. DEBRIDEMENT AND POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Wound Dehiscence

  MAUDE report 22998383 ↗
• InjuryAug 5, 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 POSSIBLE INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22714506 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOCTOR CHANGED INSERT AND WASHED OUT THE KNEE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22420186 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REVISION FOR AN UNSTABLE KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21873819 ↗
• InjuryMar 7, 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 INSTABILITY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21547134 ↗
• InjuryJan 28, 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 PAINFUL TOTAL KNEE ARTHROPLASTY (TKA). DOI: UNKNOWN AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21258019 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON STATED THAT THE PATIENT'S KNEE WAS INFECTED, AND THEY PERFORMED THE IRRIGATION AND DEBRIDEMENT PROCEDURE. THE INSERT WAS REPLACED WITH A NEW ONE. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 21252282 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TKA. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 21071850 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20543801 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. POLY EXCHANGE WAS PERFORMED AFTER DEBRIEDMENT. NOTHING FURTHER TO REPORT. DOI: UNK. DOR: (B)(6) 2024. AFFECTED SIDE: UNK KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 20065358 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AS THE SURGEON TOOK OUT THE LINER TO RULE OUT INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR:(B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19948902 ↗
• InjuryJan 17, 2024Adverse 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 PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18526086 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF KNEE PAIN AND IT WAS THOUGHT THAT THE FEMUR WAS LOOSE, BUT THIS WAS NOT THE CASE. THE SURGEON MENTIONED THAT THE KNEE HAD A LOT OF FLUID IN IT, AND WENT UP A COUPLE OF SIZES ON THE POLY AND THAT WAS THE EXTENT OF THE SURGERY. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18491602 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REFERRED TO SURGEON WITH AN INFECTED TOTAL KNEE. SURGEON OPTED TO DO A TWO STAGE REVISION WITH PLACEMENT OF AN ANTIBIOTIC SPACER UNTIL THE INFECTION HAS CLEARED. AT THIS POINT HE WILL RE-IMPLANT AN ATTUNE REVISION. ALL IMPLANTS WERE REMOVED AND A SURESPACE SPACER MOLD WAS IMPLANTED WITH DEPUY 1 W/ GENT. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17261485 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON SWAPPED THE POLY DUE TO POSSIBLE INFECTION. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17009597 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16860809 ↗
• InjuryMar 27, 2023Adverse 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) 2023, AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Pain

  MAUDE report 16618055 ↗