ATTUNE 1517-10-316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295055730), received between Aug 25, 2022 and Aug 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2022Unintended Movement; Unintended Movement

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT THE PATIENT UNDERWENT THE SECOND REVISION SURGERY DUE TO FALL. THIS PC REPORTS THAT THE THIRD REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION OF THE INSERT. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SECOND REVISION SURGERY WITH THE INSERT DUE TO THE FRACTURE OF THE FEMORAL EXOCONDYLE AND THE LCL FUNCTION FAILURE. THE SECOND REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SECOND REVISION SURGERY, DISLOCATION OF THE INSERT OCCURRED. THEREFORE, THE THIRD REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THE 16MM INSERT WAS REPLACED WITH A 18MM INSERT. ACCORDING TO THE SURGEON, THE FEMORAL EXOCONDYLE WAS DISLOCATED IN CROSS-LEGGED POSITION DUE TO THE LACK OF LCL FUNCTION AT TIME OF THE SECOND REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15293236 ↗