ATTUNE 1517-10-818Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295056294), received between Aug 8, 2019 and Mar 21, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED HEMATOMAS POSTOPERATIVELY. PATIENT WAS BROUGHT TO OR FOR BILATERAL I&DS WITH POLY EXCHANGES. THERE ARE NO ALLEGATIONS AGAINST ANY COMPONENTS. THERE WAS NO DELAY OR PATIENT HARM. SURGEON FELT LIKE EARLY INTERVENTION WOULD LESSEN THE LIKELIHOOD OF INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 21666314 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. B. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS NO.

  Patient problems: Unspecified Infection

  MAUDE report 20492427 ↗
• InjuryDec 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE FEMUR WAS DISLOCATED AT ONE TIME BUT HAD BEEN REDUCED AT THE TIME OF THE PROCEDURE. NOTHING LOOKED OUT OF THE ORDINARY.

  Patient problems: Joint Dislocation

  MAUDE report 18358447 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO DELAY AND NO HARM TO THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18084294 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A TORN EXTENSOR MECHANISM. A POLY EXCHANGE WAS PERFORMED DURING THE REPAIR. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17107284 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I&D. POLY SWAP WAS PERFORMED. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE, THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 16662787 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT AND SWELLING IN THE KNEE. THE SURGEON REMOVED THE POLY, TOOK CULTURES FOR POSSIBLE INFECTION, WASHED OUT THE KNEE, PLACED NEW POLY IN AND PUT ANTIBIOTIC BEADS INTO JOINT SPACE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, UNK AFFECTED SIDE.

  Patient problems: Discomfort; Edema; No Code Available; Unspecified Infection

  MAUDE report 10206111 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I&D AND POLY EXCHANGE WERE PERFORMED. DOI: WITHIN THE PAST 6-8 MONTHS; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8874673 ↗