ATTUNE 1518-20-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295541677), received between Dec 14, 2022 and Jul 27, 2026 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to infection. DOI- (b)(6) 2026.DOR- (b)(6) 2026.Affected side- Left knee.

  Patient problems: Unspecified Infection

  MAUDE report 50024405 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR SYNOVECTOMY LOW RANGE OF MOTION. CHANGED POLY ADDED PATELLA. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Loss of Range of Motion; Synovitis

  MAUDE report 24489220 ↗
• InjuryNov 12, 2025Adverse 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) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23535026 ↗
• InjuryAug 14, 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 GLOBAL INSTABILITY AFTER TORN IT BAND. POLY WAS SWAPPED FROM A 5X8 LEFT FBMS TO A 5X14 LEFT FBMS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 22803431 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS COMING BACK IN FOR A POLY SWAP OF A CR MS DONE ON (B)(6) 2023. THE DOCTOR DECIDED IT WAS BEST TO INCREASE THE POLY THICKNESS FROM AN 8 TO A 12 TO PROVIDE A STABLE JOINT.

  Patient problems: Joint Laxity

  MAUDE report 21223340 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAINFUL LEFT KNEE AND UNDERWENT REVISION KNEE SURGERY AND REMOVAL OF HARDWARE WITH HINGE KNEE REPLACEMENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21095165 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND NEEDED WASH OUT. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE;

  Patient problems: Fall

  MAUDE report 17071255 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST OP AND THE WOUND OPENED. THE SURGEON DID WASH OUT AND POLY SWAP. THERE WAS NO SURGICAL DELAY. DOI : (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE : LEFT KNEE. .

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 15983803 ↗