ATTUNE 1517-10-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295055709), received between Jul 15, 2022 and Nov 30, 2023 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND OPENED THE INCISION. SO SURGEON DID A POLY EXCHANGE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 18236411 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY WAS REMOVED, WASHED OUT AND REPLACED WITH A NEW POLY. DOI: (B)(6) 2020, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16418110 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT THE THIRD REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION OF THE INSERT. THIS PC REPORTS THAT THE PATIENT UNDERWENT THE SECOND REVISION SURGERY DUE TO FALL. IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE OTHER COMPANY¿S IMPLANTS FOR THE RIGHT UNILATERAL PRIMARY KNEE OSTEOARTHRITIS. AFTER THE SURGERY, THE INITIAL REVISION SURGERY WAS PERFORMED WITH THE ATTUNE REVISION ON (B)(6) 2022. THE INITIAL REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE INITIAL REVISION SURGERY, THE PATIENT FELL, AND THE FEMORAL EXOCONDYLE FRACTURED. ADDITIONALLY, THE LCL WAS NOT FUNCTIONING. THEREFORE, THE SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 15310734 ↗
• InjuryJul 15, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION SURGERY WITH THE ATTUNE INSERT FOR THE HIP JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT FELL OFF ON (B)(6) 2022, AND GAP OF FLEXION EXPANDED. ON (B)(6) 2022, A SECOND REVISION SURGERY WILL BE PERFORMED, AND THE INSERT REPLACED WITH A THICKER INSERT. THE REASON OF INITIAL REVISION SURGERY IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. UNK: HIP.

  Patient problems: Fall; Joint Laxity

  MAUDE report 15026350 ↗