ATTUNE 1549-03-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295383024), received between Apr 13, 2020 and Nov 15, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR NAUSEA AND VOMITING AND RE-ADMITTED TO HOSPITAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2005. DATE OF REVISION #1: (B)(6) 2022. DATE OF REVISION #2: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: MEDICAL WORKUP RESULTING IN DX OF SHOWER EMBOLI AND TREATED WITH ELIQUIS.

  Patient problems: Embolism/Embolus; Nausea; Vomiting

  MAUDE report 18138744 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION KNEE ARTHROPLASTY IN (B)(6) 2019. SURGEON REMOVED FEMUR AND SLEEVE AND REPLACED WITH A LARGER SIZE SLEEVE. SURGEON SAID THAT THE PATIENT WAS COMPLAINING OF PAIN. FEMUR AND SLEEVE WERE WELL FIXED AND TOOK TIME TO REMOVE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16487171 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR NEUROLOGICAL PAIN NERVUS INFRAPATELLARIS LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2022, (LEFT KNEE). TREATMENT: NEURECTOMY NERVUS INFRAPATELLARIS.

  Patient problems: Pain

  MAUDE report 13653053 ↗
• MalfunctionSep 20, 2021Difficult to Insert; Difficult to Insert

  COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT THE 3X8MM POSTERIOR AUGMENT WOULD NOT TIGHTEN WITH TORQUE WRENCH. SCRUB FELT THE SET SCREW WAS ¿ALREADY TIGHTENED". NO DELAY IN SURGERY. DOE: (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497883 ↗
• MalfunctionSep 17, 2021Difficult to Insert; Difficult to Insert

  COMPASS (B)(4) REPORT: THE PATIENT WAS REVISED DUE TO PAIN. THE PHYSICIAN REVISED FEMUR COMPONENTS TO CRS WITH STEM. DOI: (B)(6) 2017, DOR: (B)(6) 2021: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487177 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP VENOUS THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: ORAL MEDICATION (UNSPECIFIED).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12167445 ↗
• InjuryApr 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEMATOMA. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. TREATMENT INCLUDES IRRIGATION AND DEBRIDEMENT. PATIENT REPORTED DISSATISFACTION IN A CLINICAL SURVEY; (RIGHT KNEE).

  Patient problems: Hematoma; No Code Available; Pain

  MAUDE report 9954630 ↗