ATTUNE 1517-10-312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295055716), received between Jan 14, 2020 and Mar 6, 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.

• 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 16487265 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE TRACES OF DIRT ON THE SURFACE OF THE TRAY USED IN THE REVISION SURGERY. THIS PC REPORTS ABOUT THE INFECTION AFTER THE FIRST SURGERY. ON UNKNOWN DATE, THE PATIENT UNDERWENT THE FIRST SURGERY FOR UNKNOWN REASON. ON UNKNOWN DATE, THE INFECTION WAS FOUND. IT WAS SCHEDULED TO REMOVE THE TRAY DUE TO INFECTION. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY VIA TKA DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12519531 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S STRYKER PRIMARY KNEE WAS REVISED ON (B)(6) 2019. ATTUNE REVISION COMPONENTS WERE USED TO REVISE THE KNEE. THE PATIENT'S KNEE WAS REVISED A SECOND TIME ON (B)(6) 2020, DUE TO STIFFNESS. DURING THE SECOND REVISION PROCEDURE, SURGEON REMOVED THE ATTUNE REVISION INSERT AND THEN SURGICALLY REMOVED (CLEANED OUT) SCAR TISSUE THROUGHOUT THE PATIENT'S KNEE. HE ALSO PERFORMED SOME SOFT TISSUE RELEASES TO ENABLE THE PATIENT'S KNEE TO BE FULLY EXTENDED UNDER ANESTHESIA. BECAUSE THE ATTUNE REVISION INSERT WAS SCRATCHED AND INDENTED DURING ITS REMOVAL, BY THE SURGICAL INSTRUMENTATION THAT WAS USED TO PRY IT OUT, A REPLACEMENT INSERT OF THE SAME SIZE AND THICKNESS WAS IMPLANTED. A DEVICE EXPERIENCED REPORT WAS NOT SUBMITTED FOR THE (B)(6) 2019 REVISION PROCEDURE, SINCE THE PRIMARY COMPONENTS BEING REVISED WERE STRYKER COMPONENTS. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available

  MAUDE report 10460863 ↗
• InjuryJan 14, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT CROSSED HER LEGS AND THE TIBIAL INSERT SPUN 180 DEGREES. THE SURGEON DETERMINED SHE HAD LIGAMENTOUS LAXITY, SO THE SURGEON PUT IN A THICKER INSERT. THE KNEE IS STABLE. THE FEMUR, TIBIA AND PATELLA ARE WELL FIXED AND RETAINED. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9588629 ↗